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Pharmacologic and Psychologic Interventions for Procedural Pain

Anne E. Kazak, PhD*; Biancamaria Penati, PhD‡; Patricia Brophy, MSN, CRNP‡; and Bruce Himelstein, MD*

ABSTRACT. Objective. This study evaluated a com-bined pharmacologic and psychologic intervention (com-bined intervention, CI) relative to a pharmacologic-only (PO) intervention in reducing child distress during inva-sive procedures in childhood leukemia. Predictors of child distress included age, group (CI, PO), and proce-dural variables (medications and doses, technical diffi-culty, number of needles required).

Methodology. This was a randomized, controlled pro-spective study that compared the PO (n545) and CI arms (n 5 47), at 1, 6, and >12 months after diagnosis. A cross-sectional control group consisted of parents of 70 patients in first remission before the prospective study. Parent questionnaires, staff and parent ratings, and data on medications administered, technical difficulty of the procedure, and needle insertions were obtained for each procedure. This article reports on the final data point for the project (>12 months).

Results. Mothers and nurses reported lower levels of child distress in the CI than the PO group. The CI and PO groups showed lower levels of child and parent distress than the cross-sectional control group. Distress decreased throughout the time, and child age was inversely related to distress (younger children had more distress) regard-less of group. Child distress was associated with staff perceptions of the technical difficulty of the procedure and with child age, but not with medications adminis-tered.

Conclusions. The data showed that pharmacologic and psychologic interventions for procedural distress were effective in reducing child and parent distress and support integration of the two approaches. Younger chil-dren experienced more distress and warranted additional consideration. Staff perceptions of the technical diffi-culty of procedures were complex and potentially helpful in designing intervention protocols.Pediatrics1998;102: 59 – 66;pediatric oncology, pain, procedures, intervention.

ABBREVIATIONS. LP, lumbar puncture; BMA, bone marrow as-pirate; GA, general anesthesia; APPO, Analgesia Protocol for Procedures in Oncology; PO, pharmacologic-only; CI, combined intervention; CC, cross-sectional control; ANLL, acute nonlym-phocytic leukemia; PPQ, Perception of Procedures Questionnaire; POQOLS, Pediatric Oncology Quality of Life Scale.

R

educing the pain and anxiety associated with invasive procedures such as lumbar punctures (LPs) and bone marrow aspirates (BMAs) in the diagnosis and treatment of childhood cancer is a widely shared goal in pediatrics, with recommenda-tions of the American Academy of Pediatrics1

pro-viding guidelines for practice. Recent studies have explored the efficacy of different sedation regimens for painful procedures including transmucosal fent-anyl and ketamine.2– 4 Psychologic interventions

demonstrating efficacy during pediatric procedures focus on behavioral and cognitive behavioral tech-niques,5including parental coaching of children

dur-ing procedures6,7and the effectiveness of decreasing

parents’ distress.8Although there has been little

re-search on interventions in which parents are primary interventionists, it is reasonable to maximize paren-tal involvement by encouraging parents to maintain responsibility for their child’s interventions.

The systematic integration of pharmacologic and psychologic approaches and its potential complex impact on outcome has received relatively little at-tention. For example, Jay et al9reported that adding

benzodiazepine to a cognitive behavioral interven-tion did not significantly affect distress. As noted by these researchers, the benzodiazepine may have hin-dered the ability of children to learn and implement the cognitive strategies. In a study comparing cogni-tive behavior therapy with general anesthesia (GA), Jay and colleagues10found that parents reported

bet-ter behavioral adjustment 24 hours afbet-ter the proce-dure with cognitive behavior therapy than GA, al-though the GA was associated with less observed distress during the first minute of the procedure.

The current article is a report of a randomized, controlled, intervention study, the Analgesia Proto-col for Procedures in OnProto-cology (APPO) that com-pared two arms of an 18-month prospective study of pain and distress during LPS and BMAs after the diagnosis of leukemia in children and adolescents. The treatment arms contrasted a pharmacologic-only protocol (PO group) to the same pharmacologic pro-tocol plus a preventive, parent-centered psychologic intervention (CI group). A third arm of the study incorporated a control group of patients with leuke-mia in first remission before the initiation of APPO [cross-sectional control (CC group)]. The major de-pendent variables were child and parent distress based on parent and staff (ie, physician and nurse) ratings and self-report scales and procedural vari-ables that may affect outcome (distress), including the medications administered and technical diffi-From the *Department of Pediatrics, University of Pennsylvania School of

Medicine and Division of Oncology, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania; and the ‡Division of Oncology, Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania.

Received for publication Jun 12, 1997; accepted Nov 17, 1997.

Reprint requests to (A.E.K.) Division of Oncology, Children’s Hospital of Philadelphia, 324 S 34th St, Philadelphia, PA 19104 – 4399.

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culty of the procedure. The APPO protocol was a change in how procedural distress was addressed in our setting and provided an opportunity to examine changes in practice.11,12We have previously reported

on study results at 6 months13and on a parent report

instrument on procedural distress.14 The current

re-port is the full parent and staff rere-port data set at the end of the study, including procedural variables that may be predictive of distress.

There were three sets of questions for the hy-potheses. The first compared the two arms of the prospective study at the final (.12 months) data point. The second compared the prospective data with data collected before the prospective study began. For each, age was a covariate. The third hypothesis examined predictors of child distress, incorporating the procedural variables, group and age, at.12 months from diagnosis. Hypothesis 1: A) The combined intervention group (CI) will re-port lower levels of child and parent distress than the pharmacologic only group (PO). This provides a test of the effect of adding a psychologic inter-vention to the pharmacologic protocol. B) Parent and staff ratings of child and parent distress will decrease during the 18 month period for both groups. C) Parents of younger children will report higher levels of child distress before and during procedures than parents of older children and adolescents, consistent with previous literature (LeBaron S, Zeltzer L. Assessment of acute point anxiety in children and adolescents by self-reports, observer reports, and a behavior checklist. J Con-sult Clin Psychol. 1984;52:729 –738). Hypothesis 2: Children and adolescents with leukemia and their mothers and fathers in the PO and CI groups will have lower levels of child and parent distress than the CC group at .12 months from diagnosis. The rationale is that the introduction of a systematic approach to procedural pain (pharmacologic or pharmacologic plus psychologic) will result in a lessening of child and parent distress. Hypothesis 3: Child distress (staff and parent ratings) will be positively associated with technical difficulty and

number of needles and inversely associated with medication doses and age. It is also hypothesized that group CI will be inversely associated with distress.

METHODS Design

There were three groups: 1) pharmacologic-only (PO), 2) CI, and 3) CC. The PO and CI groups comprised the prospective study, with random assignment, stratified by age, to either group at diagnosis of leukemia in a child under age 18. Patients were accrued for 36 months (February 15, 1992 to February 15, 1995). Prospective data were collected at 1, 2, 6, 12, and 18 months after diagnosis. The CC group consisted of patients in treatment for leukemia in a first remission, during October and November 1991. Therefore, the CC group was not affected by a program that could have indirectly influenced the treatment patients received, or the ways in which staff interacted with patients and families. The study design is illustrated in Fig 1.

Study Group

In the PO and CI groups, participants were children and ado-lescents newly diagnosed with leukemia, and their mothers and fathers at a large, university affiliated pediatric oncology treat-ment center. The CC group consisted of families of 70 patients receiving treatment for leukemia in a first remission before the implementation of APPO. From this group of 70, we selected all families who completed the questionnaires.11 and,25 months postdiagnosis (M517.89). This subset of CC families (n534) provided a match for the.12-month prospective data from the PO and CI groups. There were no significant differences among the groups for diagnosis, age, gender, race, family structure, or parent education (Table 1).

The majority of patients were enrolled on clinical research studies of the Children’s Cancer Group, or similar protocols ap-proved by our hospital’s Institutional Review Board. All protocols required LPs and BMAs. Six to seven LPs were necessary during induction and consolidation. Thereafter (during maintenance che-motherapy), patients with acute lymphocytic leukemia received one LP every 3 months for 2 to 3 years. The protocols required two to three BMAs during induction and one upon ending treatment. Further BMAs were determined by the protocol or were per-formed when clinically indicated (eg, suspected relapse). For all patients, the medical regimen included multiagent chemotherapy. Types of procedures were: LPs (88%), BMAs (4%), and LP1BMA or other procedure combinations (8%). Staff performing the procedures were attending pediatric oncologists (33%), pedi-atric oncology fellows (56%), or pedipedi-atric nurse practitioners (11%). The majority of procedures (73%) were performed by the primary medical care provider for the patient. There were no

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differences between the CI and PO groups on these descriptive data.

Procedure PO and CI Groups

All patients with an admitting diagnosis of possible leukemia were randomized to the PO or CI groups during a 36 month period. The randomization procedure was stratified by age to assure balance developmentally. After confirmation of a diagnosis of leukemia, informed consent was obtained from parents and patients when appropriate, within 2 weeks by a staff member blinded to treatment condition. Families understood the study would evaluate the effectiveness of two approaches to procedural pain. In two-parent families, both parents were encouraged to participate. Seventy-eight percent of eligible families (n5122) consented. There were no significant differences between partici-pants and nonparticipartici-pants on age, race, gender, or diagnosis.

Patients in the PO arm received premedication according to the pharmacologic guidelines of the APPO protocol based on the American Academy of Pediatrics guidelines.1For the first

(diag-nostic) procedure, maximum safe sedation and analgesia were administered to reduce conditioned responses from an adverse first procedure. All medications were standardized and doses for safe and effective conscious sedation were outlined. Conscious sedation implies that the patient remained responsive to verbal and tactile stimuli. The medications included injectable 1% lido-caine, midazolam, and morphine sulfate. Initial doses of morphine and midazolam were 0.1 mg/kg and 0.05 mg/kg, respectively. The use of additional doses of midazolam (0.05 mg/kg up to 3 additional doses) and/or morphine (0.05 mg/kg up to 1 addi-tional dose) was encouraged to attain adequate sedation. Moni-toring by Basic Life Support-certified staff and pulse oximetry, and ready availability of the reversal agents naloxone and fluma-zenil, was enforced. Medical and nursing personnel were trained in the use of these guidelines. The use of a topical anesthetic cream (EMLA; Astra, Westborough, ME) was encouraged when it be-came commercially available.

Patients in the CI arm received the same premedication as the PO group. The psychologic intervention was developed immedi-ately after consent was obtained with the family and an APPO interventionist (a psychologist or social worker who had com-pleted a 6-hour training program in addition to supervised pro-cedural intervention experience). Parents were trained to assume a primary role in the intervention. Interventions were individual-ized based on child’s age and ability to concentrate on concrete versus abstract stimuli. Externally oriented play (eg, bubbles, video games, musical books) were usually used with children,6 years old (eg, a mother joined her 3 year old under the blanket,

their tent, reading children’s books). For children age 6 and older, external and/or abstract interventions such as guided imagery, counting, and/or breathing were used. Examples include using guided imagery to go to special places (eg, enchanted forest), feeling the warm sun relaxing their muscles, or planning how to prepare a perfect meal.

A research assistant was present at every LP and BMA for both groups and obtained data on: 1) ratings of distress from patients (patient ratings of distress were collected; however, because of the young age of the samples and amnesia attributable to midazolam, only a small amount of child data seems to be valid. Therefore we have not reported the child data.), parents, and staff; 2) who performed the procedure (attending, fellow, nurse practitioner) and whether this person was the primary medical care provider for the patient; 3) medications—Whether or not EMLA cream (Astra), lidocaine, midazolam, and/or morphine was adminis-tered, and at what doses, from the nurse present; 4) ratings of technical difficulty of the procedure from the physician or pedi-atric nurse practitioner performing the procedure and the nurse present at the procedure; and 5) number of needles used for the entire procedure. Table 2 summarizes the descriptive data for medications, technical difficulty, and number of needle insertions. For the CI group, an interventionist accompanied the child and family to each procedure. At 1, 2, 6, 12, and 18 months after diagnosis parents completed questionnaires. As with any prospec-tive study, there was shrinkage in the sample throughout the time. During the course of the study, GA was introduced as an option for procedures and 12 APPO patients (8 in the PO group and 4 in the CI group) received subsequent procedures under GA. Patients with acute nonlymphocytic leukemia (ANLL) had completed their treatment before the .12 month point. Therefore, the potential sample at the.12 month point consisted of 31 patients in the CI group and 21 in the PO group. Patients who relapsed, were referred for bone marrow transplantation, died, or moved resulted in further decreases for some analyses at some data points.

At the time at which the CC group was treated, there was no systematic approach or recommendations at this treatment center regarding how children’s distress during procedures should be handled. Although all patients received some pharmacologic sup-port (premedication in the form of analgesics and/or sedatives), medications and doses varied. All patients had a social worker or psychologist who provided psychosocial services, but no preven-tive psychologic interventions were administered specific to pro-cedural distress. Packets with questionnaires for mothers and fathers, a consent form, and a postage paid envelope were mailed to all eligible families. Follow-up letters and calls were used as needed. The participation rate for the CC group was 83.3%.

Measures

The PPQ and POQOLS are instruments for which clinical cut-offs have not yet been reported in the literature.

TABLE 2. Medication and Doses, Technical Difficulty, and Total Number of Needles*

Medication % Received Mean Dose (mg/kg)

Range (mg/kg)

EMLA 92.2% NA NA

Lidocaine 80.4% NA NA

Midazolam 77.8% .12 .05–.40

Morphine 92.5% .11 .10–.20

Mean S.D. Technical difficulty†

Nurse rating 2.2 1.4

Physician/pediatric nurse practitioner rating 1.8 1.1 Lidocaine applications 1.3 .7 Total number of needles 2.3 .8 Abbreviation: EMLA, lidocaine and prilocaine cream.

* There were no significant differences between the combined intervention (CI) and pharmacologic-only (PO) groups on these variables.

† 15minimally difficult; 75extremely difficult.

TABLE 1. Sample Description

PO CI CC

Patients n545 n547 n570 Mothers n543 n546 n568 Fathers n530 n533 n566 Age at diagnosis M55.42 y M55.75 y M55.90 y

SD54.39 y SD54.66 y SD54.13 y Gender

Female 47% 51% 54%

Male 53% 49% 46%

Diagnosis

ALL 78% 87% 80%

ANLL 22% 13% 20%

Family structure

Two-parent families 78% 79% 89% Single-parent families 22% 21% 11% Ethnicity

White 80% 85% 90%

African-American 11% 15% 6%

Hispanic 2% 0% 1%

Asian 4% 0% 3%

Asian-Indian 2% 0% 0%

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The Perception of Procedures Questionnaire (PPQ)

The PPQ is a 19-item scale assessing parent perceptions of procedures.14 Principal components factor analyses were

con-ducted using pairwise deletions and varimax rotations and yielded a five factor solution: parent satisfaction; child distress during procedure; child distress before procedure; parent distress; and parent involvement. In this study we report data from the first four subscales. Cronbach’s coefficient alphas for the total and factor scores were strong (r5.84 to .95). Lower scores indicated lower levels of child and parent distress and higher ratings of satisfaction.

The Pediatric Oncology Quality of Life Scale (POQOLS)

The POQOLS was a 21-item scale measuring frequency of patients’ daily activity during a 2 week period.15It yielded a total

score and three factor scores, presented here with mean scores from the normative sample: role restriction and physical function-ing (M525.5); emotional distress (M520.6); and response to current medical treatment (M518.1). For the total score, the mean was 65.2 (range, 24 to 121). Internal consistency measured by coefficient alphas yielded reliability scores for the three factors ranging from 0.68 to 0.87. Lower scores indicated better quality of life.

Parent and Staff Ratings of Distress

For the PO and CI groups, immediately after each procedure, parents were shown two 7-point Likert-type items, asking them to rate their child’s and their own distress. The oncologist or nurse practitioner completing each procedure and the nurse present for the procedure used 7-point Likert-type scales to rate child and parent distress. Lower scores indicated less distress.

Procedural Distress

To assess the technical difficulty of each procedure, the oncol-ogist or nurse practitioner completing the procedure and the nurse present for the procedure rated each procedure on a 7-point scale from 1 (minimally difficult) to 7 (extremely difficult). Information on doses and the number of needles used for the total procedure was also obtained.

RESULTS Statistical Analyses

Repeated measure analyses of covariance were conducted for Hypothesis 1. The between factor was group (CI, PO); the within factor was time (1, 6,.12 months postdiagnosis). When both a 12- and 18-month data point was available, the 18 18-month point was included in the analyses. For some patients, the 18-month data point was missing, because of having ended treatment (eg, patients with ANLL), relapse, death, or having moved. In these cases, the 12-month data point was used in place of an 18 month point. Child age at diagnosis was a covariate. Repeated

measure analyses of covariance were conducted for Hypothesis 2. Stepwise multiple regressions were used for Hypothesis 3. Analyses of mother and father data were conducted separately. Mothers only were present for 53% of the procedures. Mothers and fa-thers attended 32% of procedures, and fafa-thers alone were present 16% of the time.

Group Differences (Hypothesis 1)

Hypothesis 1A pertained to group (PO, CI) differ-ences in child and parent reported distress. There were three significant main effects supportive of the hypothesis (see Tables 2 to 4). Mothers in the CI group reported on the PPQ that their children were significantly less distressed during procedures than mothers in the PO group (P,.01). Similarly, nurse ratings of distress also showed significantly less child distress for the CI group (P,.02). Fathers rated their satisfaction on the PPQ as significantly higher in the CI group than the PO (P,.05). There were no group significant differences on the other self-report mea-sures for parents nor for physician ratings (Tables 3 and 4).

Support for the hypothesis that distress would decrease throughout time (Hypothesis 1B) was strong. On the PPQ for mothers, child distress during procedures (P,.05) declined (Tables 2 and 3). This was consistent with mother ratings of decreased child distress throughout the time (P , .001) and their own stress (P , .005). Nurse (P , .01) and physician/nurse practitioner (P , .001) ratings of parental distress also showed significantly less dis-tress throughout the time. Mothers’ POQOLS scores indicated a significant time effect for total, F (P , .0001), role restriction/physical functioning (P , .0001), and response to current medical treatment (P , .0001), and emotional expression (P , .01). Fathers’ POQOLS scores yielded a significant effect for total (P , .002) and role restriction/physical functioning (P , .0001), and response to current medical treatment (P,.01).

On the PPQ, for mothers, ratings of child distress before procedures increased throughout the time for the PO group while it decreased throughout the time for the CI group (P , .05). Age at diagnosis was a significant covariate. On the PPQ, mothers (P , .0001) and fathers (P, .01) described younger

chil-TABLE 3. Child Distress: Parent, Nurse, MD/Pediatric Nurse Practitioner (PNP) Ratings for PO and CI Groups at 1, 6, and.12 Months

Pharmacologic-only (PO) (Months) Combined Intervention (CI)

(Months)

Significance (P)

1 6 .12 1 6 .12 Group Time Age Group by

Time Interaction

Mother PPQ distress: during 20.9 19.2 17.6 15.8 12.9 12.3 .01 .05 .0001 NS Mother PPQ distress: before 8.7 10.8 10.1 10.4 7.4 8.5 NS NS NS .05 Father PPQ distress: during 18.5 16.4 16.6 18.2 15.6 15.4 NS NS .01 NS Father PPQ distress: before 8.6 9.4 8.9 14.2 10.0 10.3 NS NS NS NS

Mother rating 4.6 3.7 3.0 3.4 3.2 2.5 NS NS .001 NS

Father rating 3.9 3.1 3.5 3.1 3.1 2.5 NS NS NS NS

Nurses child distress 3.5 3.1 3.0 2.4 2.6 2.3 .05 NS .005 NS

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dren as significantly more distressed during proce-dures than older children.

Differences Among CC, PO, and CI Groups (Hypothesis 2)

Parents in the PO and CI groups were expected to have less distress than the CC group. Significant group differences were found for maternal (P , .0001) and paternal (P , .05) PPQ ratings of child distress during procedures, with significant differ-ences between the CC and the PO and CI groups for mothers, and the PO and CC groups for fathers. Significant group differences were also found for maternal (P , .0001) and paternal (P , .05) PPQ ratings of parents’ own distress. For both mothers and fathers, the significant differences were between the CI and CC groups. Finally, a significant effect was found for mothers’ PPQ satisfaction (P , .05) with CI group mothers reporting significantly higher levels of satisfaction than the CC group. For quality of life, significant group differences were found for

response to treatment for mothers (P,.01). Quality of life was higher in the CI group than the CC group (Table 5).

Predicting Distress From Procedural Variables (Hypothesis 3)

Three stepwise multiple regressions were per-formed, with mother, nurse, and physician/nurse practitioner ratings of child distress as the outcome. Child’s age at diagnosis, technical difficulty of the procedure, group (CI, PO), and administration and doses of lidocaine, EMLA (Astra), midazolam, and morphine were entered as predictors. As is summa-rized in Table 6, across all three analyses, child age at diagnosis and technical difficulty were associated with distress. That is, younger children and proce-dures that were perceived as more difficult were predictive of child distress. For nurses, group was associated with distress, with lower levels of child distress in the CI group (Table 6).

TABLE 4. Parent Distress, Satisfaction, and Quality of Life (QL) for PO and CI Groups Pharmacologic-Only

(PO) (Months)

Combined Intervention (CI) (Months)

Significance (P)

1 6 .12 1 6 .12 Group Time Age Group by

Time Interaction

Mother PPQ distress 8.4 7.3 8.2 6.8 5.8 5.5 NS NS NS NS

Mother PPQ satisfaction 8.4 9.1 8.9 10.2 8.3 9.0 NS NS NS NS Mother QL: role restriction 33.2 25.9 17.6 37.7 25.8 19.0 NS .0001 NS NS Mother QL: emotional expression 21.8 19.7 17.6 23.0 20.7 19.7 NS .01 NS NS Mother QL: response to treatment 18.9 15.1 11.7 20.5 16.8 15.7 NS .0001 NS NS Mother QL: total 73.8 56.8 47.4 85.3 65.3 52.8 NS .0001 NS NS Mother rating distress 4.1 3.1 2.8 3.1 2.8 2.3 NS .005 NS NS

Father PPQ distress 8.1 8.0 8.3 5.3 6.4 5.4 NS NS NS NS

Father PPQ satisfaction 11.5 11.1 10.2 8.1 7.0 7.9 .05 NS NS NS Father QL: role restriction 38.1 29.2 20.7 35.6 20.0 18.8 NS .0001 NS NS Father QL: emotional expression 19.4 17.6 16.4 21.9 20.1 18.2 NS NS NS NS Father QL: response to treatment 16.7 17.3 12.7 18.4 14.0 13.1 NS .01 NS NS Father QL: total 75.7 66.3 51.2 75.6 52.1 49.8 NS .005 NS NS Father rating distress 3.4 3.0 3.1 3.5 3.3 2.9 NS NS NS NS MD/PNP rating of parent present 3.1 2.1 1.9 2.4 2.4 1.5 NS .001 NS NS Nurse rating of parent present 3.3 2.7 2.4 2.7 2.6 2.2 NS .01 NS NS Abbreviation: PNP, pediatric nurse practitioner.

TABLE 5. Child and Parent Distress at.12 Months for CC, PO and CI Groups

CC PO CI Significance (P)

Group Age

Child distress

Mother PPQ child distress: during 24.1 18.2 14.7 .0001 .005

Mother PPQ child distress: before 11.2 10.7 8.9 NS NS

Father PPQ child distress: during 23.7 16.8 17.5 .05 NS

Father PPQ child distress: before 10.8 8.8 11.1 NS NS

Parent distress

Mother PPQ distress 10.3 8.6 5.9 .0001 NS

Mother PPQ satisfaction 12.2 9.1 8.7 .05 NS

Mother QL: role restriction 20.7 18.6 20.4 NS NS

Mother QL: emotional expression 16.6 17.3 18.3 NS NS

Mother QL: response to treatment 10.6 11.9 15.1 .01 NS

Mother QL: total 53.0 53.3 47.3 NS NS

Father PPQ distress 9.7 7.9 5.8 .01 NS

Father PPQ satisfaction 12.0 9.5 8.6 .05 NS

Father QL: role restriction 19.1 21.5 17.6 NS NS

Father QL: emotional expression 17.8 18.4 16.7 NS NS

Father QL: response to treatment 13.0 13.4 12.5 NS NS

Father QL: total 49.8 47.4 53.4 NS NS

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DISCUSSION

Pharmacologic and psychologic interventions for procedural distress in childhood leukemia have much to offer patients, parents, and staff with regard to reducing the distress associated with these neces-sary components of treatment. As the data presented indicate, the outcomes were complex when compar-ing different treatment protocols. At the end point of an 18-month randomized controlled prospective trial, mothers in the CI group perceived a lower level of their child’s distress during procedures than mothers in the PO group, in support of our predic-tion. The nurses’ ratings supported this finding al-though other measures showed no significant effects of the CI condition over the PO condition. However, when compared with the CC group who did not receive any systematic intervention protocol for pro-cedural distress, both intervention conditions seemed to offer parents and children efficacious methods of lowering distress. It is also notable that even those differences that were not statistically sig-nificant generally favored the CI condition, trends that might be amplified in a larger sample. We also found that twice as many patients in the PO group than the CI group (8 as contrasted with 4) were referred for GA, possibly reflecting an added benefit of the CI treatment in modulating more extreme reactions to procedures.

Child distress during procedures generally de-creased throughout time and quality of life in-creased, regardless of intervention group. These data were encouraging in that they indicated that the family and treatment team were likely to achieve a successful intervention plan that helped children de-crease their distress and cope with treatment. The finding that group and time interacted with respect to child distress before procedures (that the CI group decreased in distress throughout time while the PO

group increased), suggests that the parent focused intervention may have provided a means by which parents could apply the intervention strategies be-fore coming to the clinic. In practicing their interven-tions, parents may have successfully decreased dis-tress earlier (eg, anticipatory anxiety) rather than waiting for the administration of medications in the clinic. CI parents may have also felt more confident about having an active role in the intervention and thereby less apprehensive about the procedure be-forehand.

The quality of life data similarly indicate that im-provements are likely to be seen during the course of the first year and one-half of treatment, consistent with results reported by others.16 These data

high-light the inherent fluidity in quality of life and other aspects of psychologic adjustment. That is, child and family psychologic adjustment were not stable. The data were consistent with a model of parents coping successfully with extremely stressful situations. That is, despite the demands of treatment and their report of distress in their child before and during proce-dures, both mothers and fathers indicated that some aspects of parenting and quality of life improved during this period. Clinically, this parallels the tran-sition from induction and consolidation to mainte-nance chemotherapy, the child’s return to school or more regular activities, and increased opportunity for more normal family functioning.

We found strong and consistent inverse associa-tions between child’s age and distress during proce-dures, congruent with previous literature. With the median age for onset of leukemia at 3 to 4 years, these findings highlight the importance of identify-ing ways in which procedural distress can be allevi-ated for younger children. The data underscored the difficulty of applying psychologic approaches that are more appropriate for older children (eg, guided

TABLE 6. Procedural Predictors of Child Distress During Procedures at.12 Months

Variable R2Change Partialr b t P

Mother [R25.56,F(2,31)519.94,P,.0001]

Technical difficulty – – .64 25.36 .0001

Age at diagnosis .22 – .48 23.98 .001

Midazolam dose – .16 .10 – NS

Total needles – 2.27 2.19 – NS

Morphine dose – 2.03 2.02 – NS

EMLA – .13 .09 – NS

Group – .13 .09 – NS

Nurse [R25.40,F(3,38)58.55,P,.001]

Technical difficulty 2 – .49 3.91 .001

Age at diagnosis .13 – 2.35 22.77 .01

Group .07 – .26 2.09 .05

Midazolam dose – .16 .12 – NS

Total needles – 2.15 2.13 – NS

Morphine dose – 2.26 2.20 – NS

EMLA – 2.04 2.03 – NS

Physician [R25.31,F(2,36)58.23,P,.001]

Age at diagnosis – – 2.47 23.38 .005

Technical difficulty .13 – .36 2.62 .01

Midazolam dose – .02 .02 – NS

Total needles – 2.15 2.13 – NS

Morphine dose – .21 .18 – NS

EMLA – .06 .05 – NS

Group – .20 .17 – NS

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imagery, relaxation, hypnosis). Indeed, the psycho-logic interventions with young children centered around distraction and other play-related techniques that augment the natural relationship between young children and their parents while maintaining an appropriate developmental focus. The effective-ness of such interventions supported the importance of working with parents to address their child’s dis-tress.

Across the two treatment arms, ratings of the tech-nical difficulty of the procedure were predictive of child distress. There were also no significant associ-ations between medication doses, technical diffi-culty, and distress. These findings highlight complex interactions between technical difficulty and child distress that warrant further investigation. That is, is it the case that more difficult procedures prompt higher levels of distress, or that a distressed or diffi-cult to sedate child makes the completion of a pro-cedure more difficult? In addition to obtaining a more detailed understanding of these interactions, the data suggest that attention to refining strategies for completing procedures under adverse conditions is recommended. They also point to the importance of alternatives such as GA for patients with consis-tently difficult procedures. Finally, the contribution of high levels of child distress to the successful com-pletion of the procedure should not be underesti-mated, even when the procedurist is highly skilled and experienced.

The lack of significant findings for parental dis-tress was somewhat surprising. By encouraging par-ents to be actively involved in the procedures, it was expected that they too might experience decreased distress. The absence of this finding may be ex-plained in a few ways. First, the distress that parents experience is so significant that it may be unrealistic to expect it to decline in the first 18 months. That is, our data on posttraumatic stress symptoms showed that distress, including that associated with proce-dures, may continue for many years.17,18Second, the

results of these procedures provided critical informa-tion on the child’s treatment status. That is, concerns about relapse were realistic while awaiting the out-come of BMAs and LPs and this continued through-out time. Third, parents may not have focused on their own distress. Indeed, our expectation is often that parents should reorganize themselves and their family to address their child’s treatment related needs. In doing so, they may be unwilling, or unable, to focus on their own distress. Fourth, although chil-dren’s distress may decrease throughout time with the benefit of pharmacologic and psychologic inter-vention, parents may begin to worry about other aspects of cancer and its treatment. That is, as the acute crises of diagnosis and early stages of treat-ment pass, longer-term issues and reminders of the seriousness of the child’s illness may be evoked dur-ing procedures.

One concern in designing APPO was that it would be very difficult to maintain a control condition. We felt that as staff learned new ways of addressing procedural distress, it would be difficult to avoid a contamination of the PO group. We established

mechanisms by which we attempted to keep the groups pure. These included a blinded consent pro-cess and ongoing staff education about the purpose of the study. We also provided reassurances to pa-tients, parents, and staff that pharmacologic ap-proaches could be refined in the PO group, thereby indicating the extent to which both intervention con-ditions would emphasize the child’s comfort. In our multidisciplinary APPO work group and research meetings, these concerns were discussed with the goal of assuring adherence to the study design.

We thought that parents in the PO group might take the initiative to learn about psychologic tech-niques on their own, as the consent form outlined the two treatment conditions. Knowing that there might be something else that could help one’s child, parents might seek this out independently. These complica-tions inherent in the design may have affected the outcome. In anticipation of these difficulties, the CC group offers additional comparisons independent of the above noted complications. Although represent-ing only one data point, unlike the prospective arms, the potential for Hawthorne effects is eliminated. These CC, PO, and CI group comparisons suggest that mothers in the CI condition perceived their child’s distress before and during procedures to be lower than for the CC and PO groups. Thus, it is likely that, from mothers’ perspectives, the CI repre-sented a more efficacious approach to procedures. Because of needing to rely only on self-report data for this hypothesis, we were unable to report the extent to which staff would collaborate these find-ings, if they were to have rated the children and families before initiating APPO.

Data from a related prospective investigation of staff attitudes about APPO indicated that staff be-havior (and approaches to procedures) changed throughout time. Psychologic approaches were viewed as increasingly efficacious and staff reported increases in knowledge about and access to resources for addressing pain and distress.11In this sense, the

current data are supported and suggestive of the changes in our setting associated with APPO. Fur-ther research comparing the efficacy, feasibility, and cost-effectiveness of pharmacologic and psychologic approaches to procedural pain and distress is impor-tant for addressing the comfort and satisfaction of patients, families, and staff. Methodologically, there are other approaches that can also be utilized (eg, behavioral observation) to provide a more complete assessment of the complex interactions among the procedure, patient, family, and staff. As there are well established and diverse approaches available for reducing procedural distress, the process of how specific treatment protocols can be introduced suc-cessfully into practice also warrants further atten-tion.12 The long-term effectiveness of interventions

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as-pects of treatment (such as procedures) and their ability to function successfully after treatment ends. For example, a subset of the APPO families subse-quently participated in a study of cancer survival in which association between adjustment during and after treatment were seen.19

The results of this study have direct applicability for practice. Pharmacologic protocols based on rec-ommended standards of care have proven helpful in our setting and may be able to enhance the care of patients in hospitals and clinics where an established protocol is not utilized. Our data suggested that par-ents derived satisfaction from having participated in psychologic interventions, and that the outcome for their child is positive. The psychologic approaches used were ones that can readily be introduced to parents and other health care staff. Specific attention to the needs of younger children and their parents was supported by our results, with the need to de-velop more effective approaches for the many young children with leukemia. The data also illustrated the distress experienced by parents with regard to pro-cedures and the importance of ongoing attention to parental distress.

CONCLUSION

Support for combining psychologic and pharma-cologic approaches was mixed, although the data indicated that mothers of children with leukemia perceived lower levels of child distress in the CI condition, a finding supported by nurse ratings. Dis-tress diminished throughout time in this prospective evaluation of two active, ongoing, and efficacious interventions. At the same time, parents reported improvements in quality of life and parenting stress. Consistent with previous research, younger children exhibited more distress, signaling the need for fur-ther development of interventions for young chil-dren and their families. Finally, comparisons of the prospective study with a group of families before the initiation of the study indicated that the introduction of the procedural pain protocol was likely to have affected parental perceptions of distress and high-lighted the difficulties of maintaining strict control conditions when the laboratory is the complex, active clinical setting.

ACKNOWLEDGMENTS

This research was supported by grant 57917 from the National Cancer Institute to Anne E. Kazak, PhD.

We gratefully acknowledge the contributions of the following to the planning and implementation of the project: David Beele, LSW; Bret Boyer, PhD; Marie Burkhauser, MA; David Cohen, MD; Kenneth Covelman, PhD; Ruth Daller, MSN, CRNP; Wayne Rack-off, MD; Charles Scher, MD; Sam Scott; and Barbara Shapiro, MD; and interventionists Lamia Barakat, PhD; Lisa Gagen, LSW; Caren

Linder, LSW; and Lauren Riordan, PhD. We also thank APPO research assistants George Blackall, PsyD; Tabitha Callaway; Marc Blumberg, JD, MA; Kelly Johnson, MA; and Mary Katherine Waibel.

REFERENCES

1. Zeltzer L, Altman A, Cohen D, LeBaron S, Muneksela E, Schecter N. Report of the subcommittee on the management of pain associated with procedures in children with cancer.Pediatrics. 1990;86:826 – 831 2. Dachs RJ, Innes GM. Intravenous ketamine sedation of pediatric

pa-tients in the emergency department.Ann Emerg Med. 1997;29:146 –150 3. Marx CM, Stein J, Tyler MK, Nieder ML, Shurin SB, Blumer JL.

Ket-amine-midazolam versus meperidine-midazolam for painful proce-dures in pediatric oncology patients.J Clin Oncol. 1997;15:94 –102 4. Schecter NL, Weisman SJ, Rosenblum M, Bernstein B, Conard PL. The

use of oral transmucosal fentanyl citrate for painful procedures in children.Pediatrics. 1995;95:335–339

5. Jay S, Elliott C, Katz E, Siegel S. Cognitive-behavioral and pharmaco-logic interventions for children’s distress during painful medical pro-cedures.J Consult Clin Psychol. 1987;55:860 – 865

6. Blount R, Corbin S, Sturges J, Wolfe V, Prater J, James L. The relation-ship between adult’s coping behavior and child coping and distress during BMA/LP procedures: a sequential analysis.Behav Ther. 1989;20: 585– 601

7. Powers S, Blount R, Bachanas P, Cotter M, Swan S. Helping preschool leukemia patients and parents cope during injections.J Pediatr Psychol. 1993;18:681– 695

8. Jay S, Elliott C. A stress inoculation program for parents whose children are undergoing painful medical procedures.J Consult Clin Psychol. 1990;58:799 – 804

9. Jay S, Elliott C, Fitzgibbons I, Woody P, Siegel S. A comparative study of cognitive behavior therapy versus general anesthesia for painful medical procedures in children.Pain. 1995;62:3–9

10. Jay S, Elliott C, Woody P, Siegel S. An investigation of cognitive-behavior therapy combined with oral valium for children undergoing painful medical procedures.Health Psychol. 1991;10:317–322

11. Kazak A, Blackall G, Boyer B, et al. Implementing a pediatric leukemia intervention for procedural pain: the impact on staff.Families Systems and Health. 1996;14:43–56

12. Kazak A, Blackall G, Himelstein B, Brophy P, Daller R. Producing systemic change in pediatric practice: an intervention protocol for re-ducing distress during painful procedures.Fam Systems Med. 1995;13: 173–185

13. Kazak A, Penati B, Boyer B, et al. A randomized controlled prospective outcome study of a psychological and pharmacological intervention protocol for procedural distress in pediatric leukemia.J Pediatr Psychol. 1996;21:615– 631

14. Kazak A, Penati B, Waibel MK, Blackall G. The Perception of Procedures Questionnaire (PPQ): psychometric properties of a brief parent report measure of procedural distress.J Pediatr Psychol. 1996;21:195–207 15. Goodwin D, Boggs S, Graham-Poole J. Development and validation of

the Pediatric Oncology Quality of Life Scale.Psychol Assessment. 1994; 6:321–328

16. Brown R, Kaslow N, Hazzard A, et al. Psychiatric and family function-ing in children with leukemia and their parents.J Am Acad Child Adolesc Psychiatry. 1992;31:495–502

17. Kazak A, Barakat L, Meeske K, et al. Post traumatic stress, family functioning, and social support in survivors of childhood cancer and their mothers and fathers.J Consult Clin Psychol. 1997;65:120 –129 18. Stuber ML, Kazak AE, Meeske K, et al. Predictors of posttraumatic

stress symptoms in childhood cancer survivors.Pediatrics. 1997;100: 958 –964

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DOI: 10.1542/peds.102.1.59

1998;102;59

Pediatrics

Anne E. Kazak, Biancamaria Penati, Patricia Brophy and Bruce Himelstein

Pharmacologic and Psychologic Interventions for Procedural Pain

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DOI: 10.1542/peds.102.1.59

1998;102;59

Pediatrics

Anne E. Kazak, Biancamaria Penati, Patricia Brophy and Bruce Himelstein

Pharmacologic and Psychologic Interventions for Procedural Pain

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Figure

Fig 1. Project time lines.
TABLE 1.Sample Description
TABLE 3.Child Distress: Parent, Nurse, MD/Pediatric Nurse Practitioner (PNP) Ratings for PO and CI Groups at 1, 6, and �12Months
TABLE 4.Parent Distress, Satisfaction, and Quality of Life (QL) for PO and CI Groups
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