Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yoga, WHO 5As model intervention.
- Who it may be relevant to
- Registry conditions: Tobacco Dependence. Basic parameters: 18 years — 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use
Overview
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.
Detailed description
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
Sampling frame:
Screened positive participants will be 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 super speciality OPD at SJMCH
.
Sample recruitment/sampling method:
Participants who fulfilled the inclusion criteria will be approached by the principal investigator and/or junior research fellow, and those who agreed to participate in the study will be randomly allocated to one of two groups via simple randomization. Randomisation will be computerised. This will be done in blocks of 10. Outcome assessor will be blinded to the randomisation. Principal investigator will not be involved in randomization of participants.
Training/ interventions/assessments/ procedures in the study -Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.
Procedure:
Screening positive participants fulfilling eligibility criteria, information regarding study is given and informed consent is documented. Selection of a quit date within 21 weeks.
Standard of living index(SLI) or Modified Kuppuswamy Scale for sociodemographic data (10mins), Fagerstrom scale(5 mins), Motivation to stop smoking (1 min) .
Participants are randomized into intervention and TAU groups with 48 participants each.
For intervention group, sixty minute yoga session will be imparted. The first session shall be offline, the rest of the 6 sessions shall be online.. After Completion all assessments will be done again both of intervention and TAU groups.Follow up at 21 weeks, 1 month and at 3 months.
-To assess relapse
Hypothesis Yoga will be a feasible method to reduce craving in tobacco dependent individuals who want to quit tobacco use
Interventions
- Behavioral Yoga
Participants in yoga arm will receive intervention from an instructor who would be trained in the intervention by the yoga adviser.All the yoga exercises selected for this study are low-impact and involve highly controlled movements. All yoga exercises will be taught and supervised by a skilled yoga-instructor. The yoga-instructor will take great care to emphasize to participants that they should not go beyond their usual range of motion/comfort for any of the yoga exercises. - Behavioral WHO 5As model intervention
WHO 5As model to help patients ready to quit. The five major steps to intervention are the "5 A's": Ask, Advise, Assess, Assist, and Arrange.
Primary outcome measures
- Feasibility of yoga based intervention [Time frame: After one week of intervention]
- Craving of tobacco after intervention [Time frame: After one week of intervention]
- Craving of tobacco one month follow up [Time frame: 1 month after intervention]
- Craving of tobacco three months follow up [Time frame: 3 months after intervention]
Secondary outcome measures (9)
- Relapse rate of tobacco use (Number of participants start using tobacco again) [Time frame: After one week of intervention]
- Relapse rate of tobacco use(One month sustainability) ((Number of participants start using tobacco again) [Time frame: 1 month after intervention]
- Relapse rate of tobacco use (Three months sustainability)(Number of participants start using tobacco again) [Time frame: 3 months after intervention]
- Quit rate of tobacco [Time frame: After one week of intervention]
- Quit rate of tobacco (One month sustainability) [Time frame: 1 month after intervention]
- Quit rate of tobacco (Three month sustainability) [Time frame: 3 months after intervention]
- Relapse rate of smoking [Time frame: After one week of intervention]
- Relapse rate of smoking (One month sustainability) [Time frame: 1 month after intervention]
- Relapse rate of smoking (Three month sustainability) [Time frame: 3 months after intervention]
Eligibility criteria
Inclusion criteria
- -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
Exclusion criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
India · 1 center
- St.John's Medical College and Hospital — Bengaluru
Identifiers
NCT: NCT06488443 · STUDY23050176 · D43TW009114