Sample selection

4.2.2.1. Selection criteria of the participants

Bangladeshi adult female volunteers aged over eighteen years, living in the borough of Tower Hamlets, London, chewing paan with tobacco and participating in the tobacco cessation programme organised by Bangladeshi Stop Tobacco Project (BSTP) were recruited for this study. The participants were recruited continuously for the current study based on the same recruitment criteria of the current study as it was for the BSTP except for the male and smoker participants.

The nature and type of tobacco exposure was the same or similar for all study participants. Men were not recruited to avoid the complexity of the effect of smoking and chewing paan tobacco together, as Bangladeshi males may both smoke and chew, which is uncommon in women. Women who were medically compromised, pregnant, on Hormone Replacement Therapy (HRT) and had been suffering from concurrent illnesses such as liver disease and heart problems were not recruited for this study. Women who had a clinical history of major psychological or psychiatric illnesses were also excluded from this study.

4.2.2.2. Recruitment process

The sample was recruited from a population in an unbiased manner. The key elements for unbiased recruitment of study population were: 1) A clear case-definition as mentioned above; 2) Participants identified as volunteers who intended and entered into the paan tobacco cessation programme offered by BSTP receiving behavioural support for paan tobacco cessation, and behavioural support with appropriate nicotine replacement therapy (NRT); 3) Participants were recruited from a single residential area borough of Tower Hamlets, London.

4.2.2.3. Sample size calculation and assumptions

The sample size was calculated to be 165 volunteers for this study. It was calculated using Epi-Info Version 3.5.0, (CDCP, 2005) a statistical software package. The sample size was calculated based on the previous published reports on the prevalence of tobacco use and cessation and estimate of oral pain after paan tobacco cessation and the target population, Bangladeshi adult residents 66,000 (33.4 percent), of the study area borough of Tower Hamlets, London (Croucher et al., 2003b; Pau et al., 2003; THSP, 2007). Sample size using the following statistical assumptions was calculated and the total number was found to be one hundred and forty nine. Total number was then increased to 165 to allow dropout from the study.

Statistical assumptions were:

Confidence Interval = 95 percent Statistical power = 80 percent Risk ratio = 2.00 Odds ratio = 3.00 Tobacco cessation with behavioural support only = 25 percent Tobacco cessation with behavioural support + NRT = 50 percent Significance level = p≤0.05

Sample size = Tobacco cessation with behavioural support + tobacco cessation with behavioural support and NRT Tobacco cessation (ratio) = behavioural support alone: behavioural support and

NRT (1:2)

Oral pain (percentage) = after successful cessation 50 percent;

without cessation 25 percent

Oral pain (ratio) = after cessation: without cessation (2:1)

4.2.2.4. Counselling

All participants recruited for the study received behavioural interventions delivered by one trained counsellor. The initial one-to-one counselling session was conducted in a location of the client’s preferred place, which lasted between 20 to 40 minutes in length, followed by further proactive telephone counselling. This was in accordance with the recommendations prescribed by Cochrane Systematic Review on individual behavioural counselling for smoking cessation (Lancaster and Stead, 2009) and telephone counselling for smoking cessation (Stead et al., 2009). The BSTP tobacco cessation worker was qualified on a master degree level from one of the UK University and trained to level Three counselling and behavioural support therapy. These workers delivered non-clinical tobacco cessation counselling to the participants. This research was carried out only by the researcher. The clinical advice if required such as maintenance of oral hygiene, was given by the researcher, which was also a part of the oral clinical findings.

Data were collected separately by the researcher for the study programme and the BSTP cessation advisor collected data for the Smoking Cessation Services (NHS).

The counselling sessions incorporated the 5A’s as proposed by the UK guidelines for smoking cessation: Ask, Advise, Assess, Assist and Arrange and adopted the guiding style of counselling delivery (Rollinick et al., 2005). A guiding style is empathetic, aiming to enhance self-efficacy, individual responsibility and reaffirming personal choice and commitment. The sessions were culturally adapted and language-matching (Sylheti, Bengali and English) for the Bangladeshi women participants. In addition, there was additional reassurance regarding the nicotine replacement therapy (NRT) and if needed, reference to Islamic tenets and faith. The counselling itself addressed the socio-cultural reasons for using chewing

tobacco and explored other ways of addressing the reasons for its use. The counselling tackled issues of tobacco dependence, barriers to quitting and strategies for negotiating social situations where chewing tobacco products were likely to be consumed. For example, the counsellor had an opportunity to explore with the client alternative activities to counter boredom or preserve cultural identity.

The NRT used in this study were gum, micro tablets, lozenge and trans-dermal patch depending on the nature and severity of tobacco use and general health conditions. The participants contra-indicated for NRT for general health problems were excluded from the study and referred to a General Medical Practitioner (GMP) for further advice and management. The participants were given an option regarding paan tobacco cessation methods which were either behavioural support alone or combined behavioural support and NRT.

4.2.2.5. Frequency and duration of follow up

The participants were followed up weekly for the following six weeks by telephone.

The ‘culturally and religiously appropriate’ counselling was delivered to all participants at the start of the study and additional behavioural support throughout the study period. Any previous paan tobacco cessation attempt was evaluated and based on the effectiveness of the previous cessation attempt, the cessation method, dose and type of NRT was prescribed. The volunteer participants were followed up for six weeks. In addition, the dosage of NRT was adjusted to prevent any possible ‘under replacement’ of nicotine that may compromise successful tobacco cessation (Ebbert et al., 2007).