Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Feasibility of yoga based intervention
研究概览
简要总结
Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. There is a need to evaluate the feasibility of implementation of a well- designed yoga protocol to address craving in individuals who use tobacco in India.
详细描述
There is a high prevalence of tobacco use in the community that continue to remain underserved in terms of intervention and support for their tobacco use. Yoga is a culturally acceptable practice that can reduce craving and help people quit tobacco. However, we didn't come across Indian studies looking at yoga to reduce craving in individuals who use tobacco. There is a need to evaluate the feasibility of implementation of a well- designed yoga protocol to address craving in individuals who use tobacco in India.
Aim: To study the feasibility of yoga in reducing craving in individuals who use tobacco
Objectives:
Primary
- To evaluate the feasibility of yoga based intervention on craving in tobacco dependent individuals who want to quit tobacco use Secondary/tertiary
- To assess the effect on abstinence
- To assess quit rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded to the randomisation. Principal investigator will not be involved in randomization of participants.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •-Tobacco dependent individuals (Fagerstrom test for tobacco dependence score more than or equal to 4)
- •-Men aged 18 to 65 years
- •-Recruited from Rural community health and training centre, Mugalur, Tobacco cessation centre and OPDs of Department of general medicine, pulmonary medicine, cardiology, oncology, ENT and dental surgery and other superspeciality OPD at SJMCH
排除标准
- •Patients with recent alcohol use (last 3 months) and use of other drugs of abuse
- •-Patients with clinical diagnosis of Intellectual disability
- •-Comorbid Major mental illness including Dementia, Psychosis, Recurrent depressive disorder, Bipolar affective disorder, OCD, generalized anxiety disorder, Panic disorder and Phobias, diagnosed within the last 6 months.
- •-Patients with recent MI and stroke in the last 3 months or those physically unable to perform the yoga postures due to physical disabilities determined by clinical interview.
- •-Patients with severe hypertension(SBP≥180mmHg and BP≥120mmHg)
- •-Patients with seizures disorder
- •-Patients with COPD(GOLD-2,3 and 4)
研究组 & 干预措施
WHO 5As model intervention
The control group will be given the WHO 5As model intervention to help patients ready to quit.
干预措施: WHO 5As model intervention (Behavioral)
Intervention-yoga
Participants in intervention arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser. One week of yoga intervention with the first session offline and the rest of the 6 sessions online
干预措施: Yoga (Behavioral)
结局指标
主要结局
Feasibility of yoga based intervention
时间窗: After one week of intervention
To evaluate the feasibility of yoga-based intervention in changing craving of tobacco in comparison to WHO 5As intervention on individuals who want to quit tobacco use with Visual Analogue scale (upto score 3 not useful: scores 4,5,6 neutral; 7,8,9, 10 useful) Minimum score is 0 and maximum score is 10
Craving of tobacco after intervention
时间窗: After one week of intervention
To evaluate the feasibility of yoga-based intervention in changing craving of tobacco measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use using (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving)Minimm score is 0 and maximum is 100.
Craving of tobacco three months follow up
时间窗: 3 months after intervention
To evaluate the feasibility of yoga-based intervention in changing craving of tobacco (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving)measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use. The minimum score is 0 and maximum score is 100.
Craving of tobacco one month follow up
时间窗: 1 month after intervention
To evaluate the feasibility of yoga-based intervention in changing craving of tobacco measured by Brief Questionnaire of Smoking Urges in comparison to WHO 5As intervention on individuals who want to quit tobacco use (Scale is 10 items likert scale and total of all item scores is the score, more the score more is the craving) Minimum score is 0 and maximum is 100.
次要结局
- Relapse rate of tobacco use(One month sustainability) ((Number of participants start using tobacco again)(1 month after intervention)
- Relapse rate of smoking (One month sustainability)(1 month after intervention)
- Relapse rate of smoking (Three month sustainability)(3 months after intervention)
- Relapse rate of tobacco use (Number of participants start using tobacco again)(After one week of intervention)
- Quit rate of tobacco (Three month sustainability)(3 months after intervention)
- Relapse rate of tobacco use (Three months sustainability)(Number of participants start using tobacco again)(3 months after intervention)
- Quit rate of tobacco(After one week of intervention)
- Quit rate of tobacco (One month sustainability)(1 month after intervention)
- Relapse rate of smoking(After one week of intervention)
研究者
Vishwajit Nimgaonkar, MD PhD
Professor
University of Pittsburgh