St.John's Medical College and Hospital
Bengaluru, Karnataka, 560029, India
Location status: Recruiting
Location contact
Jewel Jones, MBBS
CONTACT
Jewel Jones, MBBS
PRINCIPAL_INVESTIGATOR
Smita Deshpande, MD
CONTACT
NCT Number: NCT06488443
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.
Interested in participating?
Request Info18 year–65 year
Male
Interventional
Not applicable
Bengaluru, Karnataka, 560029, India
Location status: Recruiting
Jewel Jones, MBBS
CONTACT
Jewel Jones, MBBS
PRINCIPAL_INVESTIGATOR
Smita Deshpande, MD
CONTACT
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
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with recent alcohol use (last 3 months) and use of other drugs of abuse
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.
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After one week of intervention
To compare effect of yoga Relapse rate of tobacco use on abstinence with WHO 5As intervention group
Time frame: 1 month after intervention
To compare effect of yoga intervention on relapse rate of tobacco use with WHO 5As intervention group
Time frame: 3 months after intervention
To compare effect of yoga intervention on relapse rate of tobacco use with WHO 5As intervention group
Time frame: After one week of intervention
To compare the change in quit rate after yoga intervention with WHO 5As intervention group
Time frame: 1 month after intervention
To compare the change in quit rate after yoga intervention with WHO 5As intervention group
Time frame: 3 months after intervention
To compare the change in quit rate after yoga intervention with WHO 5As intervention group
Time frame: After one week of intervention
To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group
Time frame: 1 month after intervention
To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group
Time frame: 3 months after intervention
To compare the change in relapse rate after yoga intervention with that of WHO 5As intervention group
Contact information is provided by the study sponsor or research team.
Triptish Bhatia, PhD
CONTACT
Vishwajit L Nimgaonkar, MD, PhD
CONTACT
University of Pittsburgh
Other
Randomized Control Study to Study the Effect of Yoga on Reducing Craving in Tobacco Dependent Individuals Who Want to Quit Tobacco Use
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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