| CTRI Number |
CTRI/2024/09/074352 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Other (Specify) [Yogic Intervention] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness Of Yogic Interventions |
|
Scientific Title of Study
|
A Randomized Controlled Trial Of The Feasibility And Initial Effectiveness Of Yogic Interventions In Tertiary Cancer Care For Tobacco Cessation: Pilot Study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
Other |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyotiben Somabhai Patel |
| Designation |
Nurse Manager |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital ,Anex Building 10th floor, Parel.
Tata Memorial Hospital,Parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167092270 |
| Fax |
02224146937 |
| Email |
jyotitmh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyotiben Somabhai Patel |
| Designation |
Nurse Manager |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital ,Anex Building 10th floor, Parel.
Tata Memorial Hospital,Parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167092270 |
| Fax |
02224146937 |
| Email |
jyotitmh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyotiben Somabhai Patel |
| Designation |
Nurse Manager |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital ,Anex Building 10th floor, Parel.
Tata Memorial Hospital,Parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167092270 |
| Fax |
02224146937 |
| Email |
jyotitmh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital,Parel,Mumbai-400012 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jyotiben S Patel |
Tata Memorial Centre |
Department of Preventive oncology Room no-313,TCC Tata Memorial Hospital,Parel,Mumbai-12
Mumbai
MAHARASHTRA |
9167092270
jyotitmh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (TMC-IEC I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group
|
During an orientation meeting potential participants will be administered the first pretest questionnaire comprising the Fagerström Test for Nicotine Dependence scale
The standardized TCC
session will be given.
Post-Intervention Assessment
After six weeks of control group finishing the program, participants will fill out the same questionnaire they did at the first meeting.
|
| Intervention |
Yogic Intervention |
Experimental group- Participants Involving Technique 10 Deep Breaths When Craving Tobacco Only
Experimental group- 20 min of 3HZ frequency music using app (morning & before sleep).
Experimental group- Weekly one phone call to participants for 6 weeks (Six phone calls)
Experimental group During each phone call MPSS scale assessment will be done and Post test after six weeks.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Current Tobacco Users (smoker or Smokeless Tobacco)
Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
Severe medical conditions contraindicating yoga practice
Cognitive impairment or inability to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study will assess the practicality and acceptability of implementing yogic interventions in a tertiary cancer care setting, including factors such as patient and healthcare provider engagement, program adherence, and any challenges encountered during the trial.
|
6 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Initial Effectiveness: The study will evaluate the immediate impact of yogic interventions on tobacco cessation outcomes, such as:
Quit rates: The proportion of participants who successfully quit smoking or using tobacco products during the trial period.
Cigarette consumption: The average number of cigarettes smoked per day or other tobacco products consumed reduces after the intervention.
Craving: The frequency and intensity of tobacco cravings experienced by participants can reduced after the intervention.
Stress and anxiety: The levels of stress and anxiety reported by participants can be reduced after the intervention. |
6 MONTH |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2024 |
| Date of Study Completion (India) |
23/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/12/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim-To compare the acute impact of breathing exercises based on yogic intervention along with Tobacco cessation counselling on cravings in abstaining from tobacco ( smoking and smokeless) with Standard Tobacco cessation counselling only. PRIMARY OBJECTIVE: To compare the efficacy of the standard TCC and the combination of TCC+Yogic Intervention on cravings in abstaining from tobacco ( smoking and smokeless). SECONDARY OBJECTIVES: To evaluate the impact of breathing exercises based on yogic intervention on cravings in abstaining from tobacco( smoking and smokeless). To assess the level of nicotine addiction in smokers using the Fagerstrom Addiction Scale, which is a widely accepted and validated tool for measuring addiction to smokers and smokeless tobacco. To evaluate the Mood and Physical Symptoms Scale is a self-report measure that assesses an individual’s mood and physical symptoms over a specified period, typically the past 24 hours. To evaluate changes in stress levels, mood, and mindfulness as potential mediators through 3Hz frequency of the intervention’s impact on tobacco cessation. Patients referred to Preventive from TCC Convenience sampling method as per inclusion and exclusion criteria Both Group-Potential Participants attend orientation and complete Pre test questions Fagerstrom and MPSS(Mood and physical symptoms scale) Both Group- TCC intervention routine session Experimental group- Participants Involving Technique 10 Deep Breaths When Craving Tobacco Only Experimental group- 20 min of 3HZ frequency music using app (morning & before sleep). Experimental group- Weekly one phone call to participants for 6 weeks (Six phone calls) Experimental group- During each phone call MPSS scale assessment will be done and Post test after six weeks. Expected Output Feasibility: The study will assess the practicality and acceptability of implementing yogic interventions in a tertiary cancer care setting, including factors such as patient and healthcare provider engagement, program adherence, and any challenges encountered during the trial. |