Top PDF Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial

Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial

Infant sleep hygiene counseling (sleep trial): protocol of a randomized controlled trial

The fieldwork team is composed of visitors, interviewers, fieldwork supervisors, and coordinators. All visitors were females with graduation in Nursing, Nutrition or Peda- gogy. Visitors training included general instructions in re- gard to the study protocol, reading of the questionnaire and fieldwork manual, detailed discussion of each ques- tion, and practice questionnaire administration among themselves and with volunteer mothers (not participating in the study). Special focus was given to the training of visitors on the delivery of the intervention: written training material focusing on normal sleep behaviors, how to facilitate sleep onset and how to manage night awakenings were produced to the intervention training. Two Pediatricians, two Psychologists, one Nutritionist and one Geneticist were the Facilitators at the training sections. The training program lasted 48 h, with 75 % of the time spent in practical sessions with volunteer mothers not belonging to the Pelotas 2015 Birth Cohort. The development of counseling skills was em- phasized. The performance of all trainees was formally assessed at the end of the training to document its ef- fectiveness and to aid the coordinators in the selection of the fieldworkers. For standardization proposals, the visitors were re-trained in the content and delivery of the intervention three months after the start of the fieldwork.
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Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial

The study has several strengths, including the low cost and durability of the interventions demonstrated in past trials. The estimated cost for 3 hours of social worker time (sufficient for the four sessions of BBTI) is US$90–126. The cost for a 16-week course of SHUTi is US$129. By comparison, the approximate retail price of generic zolpi- dem 5 mg is US$19.99 per month, or US$239.88 per year [92]. Importantly, the effects of CBT-I are more durable than those of medications [23, 24]. The trial is pragmatic in that it addresses a common clinical problem using interventions that have high potential for dissemination in real-world settings. Therapists (nurses, health educators, social workers) can be trained within a few hours to de- liver BBTI, and can reach a large number of patients when the intervention is centralized by telephone/web. Likewise, SHUTi is available to any patient with Internet access. The study also leverages an academic medical center with more than 120 clinical practices that share a common EHR within a large, integrated healthcare delivery and finance system. The trial uses EHR RRAs to recruit a sample of real-world patients with INS plus HTN and to collect key health-related outcome measures. Finally, the trial emphasizes outcomes relevant to patients, providers, and health systems. The aims focus on rigorously vali- dated patient-reported outcome measures (e.g., PROMIS measures; Fig. 4), on health indicators (e.g., health-related quality of life, HBPM) relevant to patients and providers, and on healthcare utilization and cost data relevant to healthcare systems.
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Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial

Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial

Participants receive six weekly sessions delivered by an animated “virtual therapist” (The Prof ). These sessions are self-delivered at a convenient time for each partici- pant, over an 8-week period. The program comprises a fully automated media-rich web application, driven dynamically by baseline, adherence, performance, and progress data. At the start of each session, the Prof con- ducts a progress review with the participant, explores the diary data submitted during the week, the partici- pant’s current sleep status and pattern, and progress achieved against goals previously set. Underlying algo- rithms feed the delivery of information and provide sup- port and advice in a personally tailored manner. The content of the cognitive behavioral therapy component of the intervention is consistent with the literature, and covers behavioral (for example, sleep restriction, stimu- lus control) and cognitive (for example, putting the day to rest, thought restructuring, imagery, articulatory sup- pression, paradoxical intention, mindfulness) strategies, as well as additional relaxation strategies (progressive muscle relaxation and autogenic training) and advice on
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Randomized controlled trial of computer based treatment of social cognition in schizophrenia: the TRuSST trial protocol

Randomized controlled trial of computer based treatment of social cognition in schizophrenia: the TRuSST trial protocol

The Experimental Treatment Program (SocialVille) is a computerized social cognitive remediation program con- sisting of a set of specific social cognitive exercises. To use the experimental treatment program, a participant opens a standard web browser on a broadband connected computer and goes to the experimental treatment program study web site. The participant then logs into the experi- mental treatment program server (using a study provided login that contains no personally identifiable information). The participant completes 7 cognitive exercise blocks scheduled for the day, and performs each exercise for about 6 minutes (see Fig. 2). Participants perform tens to hundreds of trials over the course of a session, with auditory and visual feedback and rewards to indicate if the trial was performed correctly or incorrectly. After each session, the difficulty of the next session is up- dated (e.g., more distractors in the response array) to ensure that each participant is appropriately challenged.
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A randomized double blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial

A randomized double blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial

Progestogens have been used to treat threatened mis- carriage for many years. In 1989, Goldstein et al. pub- lished a meta-analysis of 15 randomized controlled trials and concluded that progesterone and its analogs are in- effective in the maintenance of pregnancy in women with threatened miscarriage [8]. Some recent studies suggest that the use of progestogen is associated with re- duction in risk of miscarriage in women with threatened miscarriage [9–11]. It has been suggested that progester- one potentially sustains the survival of the embryo by shifting the immune system towards production of non- inflammatory T-helper 2 cytokines and by increasing nitric oxide production, thus improving blood flow and oxygen supply [12, 13]. Progesterone also plays an important role in keeping the myometrium quiescent, as demonstrated by enhanced uterine contractility and sen- sitivity to prostaglandins, after treatment with mifepris- tone, an anti-progestogen [14].
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Effect of low level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double blinded randomized controlled trial

Effect of low level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double blinded randomized controlled trial

There are several treatment options for fibromyalgia, such as drugs [7,8], psychotherapy [9], hydrotherapy [10], electrotherapy [11], exercise [12] and laser therapy [13,14]. However, there is no consensus or defined protocol regarding the use of these treatment options. Low-level laser therapy (LLLT) is one of the more recent pain treatment modalities in the field of physical ther- apy. According to Laakso et al. [15], the analgesic effect of phototherapy may be mediated by hormonal/opioid mechanisms, the responses of which depend directly on the dose and wavelength used to irradiate the tissue. Thus, the parameters directly affect the results. LLLT is also reported to act on peripheral neural stimulation and the regulation of microcirculation, interrupting pain mechanisms and promoting analgesia [16]. The
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The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial

The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial

Subjective measurements related to sleep Multiple sleep-related variables are measured to characterize the impact of sleep disorders in the population. The German version of the Pittsburgh Sleep Quality Index [105] is used to quantify subjective sleep disturbance. This 18 item scale assesses subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep dis- turbances, use of sleeping medication, and daytime dysfunction. It has adequate psychometric properties (Cronbach ’ s α = 0.83) [106]. The corresponding global score with a cut-off value of ≥ 5 has been shown to distinguish good and poor sleepers [107]. We measure sleep reactivity, i.e., the degree to which an individual experiences disrupted sleep due to stress, with the Ford Insomnia Response to Stress Test [108, 109]. The nine-item self-report questionnaire is answered on a four-point Likert scale (not very likely to very likely) with higher total scores indicating a higher likelihood of stress-induced insomnia. The reliability (Cronbach ’ s α = 0.80) and validity of the German version have been demonstrated [110]. Dysfunctional sleep-related thoughts and attitudes are related to the development and trajectory of sleep disorders [111]. The reliability and vali- dity of the German short form of the dysfunctional beliefs and attitudes about sleep scale have recently been de- monstrated (average Cronbach ’ s α = 0.71) [112]. Sixteen items measure four domains (consequences, worry/help- lessness, expectations, medication) on a ten-point Likert scale (strongly disagree to strongly agree). Excessive day- time sleepiness is associated with insomnia and depres- sion [113, 114] as well as reduced quality of life and work performance [115]. We assess chronic daytime
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Effect of strength training on sleep apnea severity in the elderly: study protocol for a randomized controlled trial

Effect of strength training on sleep apnea severity in the elderly: study protocol for a randomized controlled trial

Methods/design: This is a randomized clinical trial including patients between 65 and 80 years of age, with obstructive sleep apnea, and an apnea-hypopnea index (AHI) between 20 and 50 events/hour, diagnosed by out-of-center in-home type III polysomnography. Forty subjects will be included and randomly assigned to two equal sized groups. The participants allocated to the intervention group will attend two sessions per week of one-hour strength training for the legs, arms, chest, back, and abdomen and the controls will receive advice on lifestyle change. The primary outcome measure of the study will be the change in apnea-hypopnea index and the secondary outcomes will be the body composition, evaluated by anthropometric and bioelectrical impedance variables; maximum dynamic force, appraised by one-repetition maximum strength test; muscle quality and thickness by ultrasound; physical function assessed by sit-to-stand test, timed up and go test, handgrip strength test. The study duration will be 12 weeks. Intention-to-treat and per-protocol analyses will be performed.
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Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial

Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial

A key issue is the association of FM with other mus- culoskeletal comorbidities, such as temporomandibular dysfunction (TMD) [5]. It has been shown that TMD can develop as a result of mandibular compression dur- ing daily living activities and sleep in the patients with FM [5–7], in which the coexistence of these pathologies generates a clinical outcome of high complexity [8]. Un- fortunately, no published studies of patients with FM and TMD have evaluated an effective pharmacologic and/or nonpharmacologic therapeutic intervention. Pre- vious studies have examined only the role of different interventions in the situation of a pathology per se. In this issue, exercise training is highly recommended in the controlling of patients with FM. Aerobic, strength, and mixed training programs (combination of aerobic, strength, and flexibility) were shown to reduce pain, num- ber of tender points, fatigue, depression, and anxiety and to improve health-related quality of life as well as func- tional capacity [9, 10]. Exercises targeted for the face are also indicated for treatment of TMD as a procedure com- bined with other therapies (e.g., electrotherapy, physio- therapy, temporomandibular joint mobilization, and facial massage) to improve pain sensitivity [11–13].
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The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial

The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial

Patients will be recruited from services across the Oxford Health NHS Foundation Trust, which covers a population of 1.1 million. We will seek referrals from all relevant outpatient and inpatient clinical teams who see patients with schizophrenia and related diagnoses. The inclusion criteria are: a current delusion or hallucination that has persisted for at least three months; a score of at least 2 on the distress scale of the Psychotic Symp- tom Rating Scales (PSYRATS) for either a delusion or hallucination [18]; a clinical diagnosis of schizophrenia, schizoaffective disorder or delusional disorder (that is, diagnosis of nonaffective psychosis (F2) in the Inter- national Classification of Diseases and Diagnostic and Statistical Manual IV); sleep difficulties lasting one month or longer with an ISI score of 15 or above (that is, above subthreshold insomnia). Participants must be aged between 18 and 65, and, where changes in medi- cation are being made, entry to the study would not occur until at least a month after stabilization of dos- age. It should be noted that we will be seeing patients
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The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial

Overall the evidence shows that chlorthalidone and amlodipine are the most effective drugs for the initial treatment of hypertension. Their use in OSA has not been appropriately tested to date. Thus, a trial testing the effi- cacy of these drugs to control both blood pressure and sleep apnea is warranted. Such a trial could contribute to our understanding of the relation between hypertension, fluid levels, hypoxia and OSA.

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Weighted Blankets and Sleep in Autistic Children—A Randomized Controlled Trial

Weighted Blankets and Sleep in Autistic Children—A Randomized Controlled Trial

Professor Gringras was involved in the design of the study, the funding application, development of the protocol, and recruitment of patients as a local principal investigator; was co – chief investigator for the trial and a member of the trial management group; and cowrote the article; Dr Wiggs contributed to the design of the study, the funding application, and development of the protocol; advised on the use of actigraphy and patient-reported outcomes; was principal investigator and co – chief investigator for the trial; was a member of the trial management group; and helped write the article; Ms Rush coordinated the trial, recruited patients, scored actigraphy, helped write the article, and was a member of the trial management group; Ms Sparrowhawk and Ms Pratt recruited patients, helped write the article, and were members of the trial management group; Dr Wright helped recruit patients and coordinate the trial, helped write the article, was co – principal investigator for the trial, and was a member of the trial management group; Ms Hooke and Ms Moore helped recruit patients, respond to family queries, and collect and record data; Dr Allgar helped with the statistical analysis plan, analyzing data, and writing the article; Dr Green contributed to the design of the study, the funding application and ethical submission, advised on the use of sensory questionnaires and patient reported outcomes, helped write the article, and was a member of the trial management group; and Dr Zaiwalla helped with the initial study design and recruitment as lead clinician from the Oxford Group and helped write the article.
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A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)

A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)

The Brazilian National Review Board (CONEP) approved the study under the number 1.055.555. Each local Institutional Review Boards also approved the study protocol (a list of ethic committee is available in Additional file 1). Protocol modifications will be reported to each relevant part including national and local institutional review boards and will be available to trial participants through the project website, to the investigators by an internal bulletin, to the registries and journals by publications, and to regulators by the review board report. A written informed consent will be obtained from study participants. In case of an eligible participant under 18 years old, a consent form will be signed for both the underaged participant and his/her legal guardian/parent before been admitted into the study.
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A scalable cognitive behavioural program to promote healthy sleep during pregnancy and postpartum periods: protocol of a randomised controlled trial (the SEED project)

A scalable cognitive behavioural program to promote healthy sleep during pregnancy and postpartum periods: protocol of a randomised controlled trial (the SEED project)

The sleep intervention aims to address 3 types of peri- natal sleep complaints identified in the literature: [1] symptoms of insomnia, [2] pregnancy and infant-related sleep disturbance, and [3] sleep-related daytime impair- ments (e.g., sleepiness, fatigue). The following evidence- based therapeutic components are included: (a) General skills for better sleep to promote resilience to sleep chal- lenges: sleep hygiene, identifying and addressing unhelp- ful thoughts and beliefs about sleep, relaxation, and strategies for calming the mind when trying to sleep; (b) Understanding the difference between symptoms of in- somnia versus sleep deprivation, and managing sleep ini- tiation and maintenance difficulty using stimulus control; time-in-bed restriction is not included in writ- ten materials, but administered by the trained psycholo- gist if necessary; (c) Education about typical sleep patterns of new parents and infants to foster realistic ex- pectations about sleep and normalise some sleep loss; (d) Mindfulness-based strategies targeting physical dis- comfort, pain, and cognitive arousal; (e) Strategies to
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Sleep Treatment Outcome Predictors (STOP) Pilot Study: a protocol for a randomised controlled trial examining predictors of change of insomnia symptoms and associated traits following cognitive–behavioural therapy for insomnia in an unselected sample

Sleep Treatment Outcome Predictors (STOP) Pilot Study: a protocol for a randomised controlled trial examining predictors of change of insomnia symptoms and associated traits following cognitive–behavioural therapy for insomnia in an unselected sample

In this study, we obtained saliva samples from our participants after obtaining consent during the recruit- ment days. Samples were collected by a researcher from the BioResource team in compliance with their ethically approved protocol. The BRC is the custodian of the samples received. On receipt, samples were logged and prepared for extraction of DNA. The BRC ensured that genetic samples were processed in accordance with strict health and safety guidelines and under the requirements of the Human Tissue Act (HTA). King’s College London holds a HTA licence, number: 12293. All samples are stored in tubes labelled with a barcode that includes the participant number. The link between the participant ID and de-identified data is kept in a secure folder. The DNA samples collected as part of this study are stored by the BRC for future analysis and hypothesis testing with appro- priate ethical approval in the future, and under existing BRC BioResource approvals.
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Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep

Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep

This paper describes the protocol for a two-arm RCT that assesses the benefits of online CBT-I compared with an alternative, active control intervention (online patient education about sleep (PE)). First, we will examine any differential change in the severity of insomnia, imme- diately after completing the interventions. Second, we will examine if there are differential changes in symp- toms of physical and mental health (eg, psychological distress, fatigue and health-related quality of life) imme- diately postintervention, and whether any improvements in insomnia or other symptoms are reported at further follow-ups (6 months and 24 months post-treatment). Third, we will use national registry data collected routinely in Norway to compare rates of time off work due to sick leave days for up to 2 years before and after participating in the RCT, as well as monitoring medication and health resource utilisation according to condition in the same time interval. Fourth, we will try to extend the knowledge base about online interventions by undertaking explor- atory analyses to assess whether change in specific clinical variables (eg, sleep variability, psychological measures of beliefs about sleep) mediate the effects of the CBT-I inter- vention. Lastly (subject to additional funding to collect saliva samples), we will examine a subset of psycho-bio- social factors to try to identify potential treatment moder- ators that might inform the stratification of individuals with insomnia into ‘treatment-relevant’ subgroups in the future.
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A randomized controlled trial of an intervention for infants’ behavioral sleep problems

A randomized controlled trial of an intervention for infants’ behavioral sleep problems

Our secondary outcomes were infants’ longest sleep time in minutes (actigraphy) and mean wakes (actigraphy and diary) and parents’ experiences, using the Multi- dimensional Assessment of Fatigue Scale [MAF] [33], Center for Epidemiologic Studies Depression Measure [CESD] [34], Pittsburgh Sleep Quality Index [PSQI] [35], and Maternal (parental) Cognitions about Infant Sleep Questionnaire [MCISQ] [36], at six weeks post-teaching session. For psychological measures, higher scores indicate more difficulty. There is support for validity and reliability; instrument testing occurred in the pilot study [14, 15]. For the trial, Cronbach’s alphas were: MAF 0.94, 0.95; CESD 0.90, 0.89; PSQI 0.64, 0.53; MCISQ 0.79, 0.84. The MCISQ has not been validated with fathers; however, Morrell’s items were developed from therapy vignettes for couples experiencing an infant sleep problem [36] and other studies have used the measure with mothers and fathers [22, 23]. Our original secondary hypothesis specified sig- nificantly improved changes in experimental versus con- trol group parents’ experiences; however, we capitalized on data from both parents by conducting a post hoc analysis comparing primary and secondary caregivers separately.
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A randomized controlled trial of Tai chi for balance, sleep quality and cognitive performance in elderly Vietnamese

A randomized controlled trial of Tai chi for balance, sleep quality and cognitive performance in elderly Vietnamese

In a randomized, controlled trial, 102 subjects were recruited. Six subjects did not meet the exclusion criteria (Mini Mental State Examination score $ 25). Subjects were divided randomly into two groups – Tai chi group and control group. The subjects were expected to consent and volunteer. Participants in the Tai chi group (n = 48, mean age = 69.2 years, standard deviation = 5.3) were assigned 6 months’ Tai chi training. Participants in the control group (n = 48, mean age = 68.7, standard deviation = 4.9) were instructed to maintain their routine daily activities and not to begin any new exercise programs. Statistical analysis was based on previous findings, 10,11 using the standardized mean difference of the group
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Behavioral Interventions for Infant Sleep Problems: A Randomized Controlled Trial

Behavioral Interventions for Infant Sleep Problems: A Randomized Controlled Trial

This randomized controlled trial of behavioral interventions for infant sleep problems found meaningful effects for both graduated extinction and bedtime fading. Compared with the control group, large reductions in nocturnal wakefulness resulted from each treatment. Despite assertions that extinction-based methods may result in elevated cortisol, emotional and behavioral problems, and insecure parent-infant attachment, our data did not support this hypothesis. Coupled with the findings from Price and colleagues, 41

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Preventing Early Infant Sleep and Crying Problems and Postnatal Depression: A Randomized Trial

Preventing Early Infant Sleep and Crying Problems and Postnatal Depression: A Randomized Trial

Our study had a number of strengths. We recruited a large community sample with a diversity of sociodemographic characteristics, including infants born to experienced caregivers. We used validated measures of infant behavior (diary) and caregiver mental health. We used multiple imputation to account for missing data at follow-up with little change in our outcomes, suggesting that sample attrition has not biased our fi ndings. Limitations include attrition rate at 6 months, use of caregiver re- port, and a lack of blinding of the intervention, which may lead to re- sponder bias. However, an absence of group differences in infant outcomes suggests that the latter is unlikely. Compared with adults residing in the state of Victoria, 41 our caregivers were
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