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CTRI Number  CTRI/2023/05/052258 [Registered on: 03/05/2023] Trial Registered Prospectively
Last Modified On: 02/05/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Well being sessions]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of practice of Yoga, Pranayam and Well being sessions on Pain Tolerance  
Scientific Title of Study   Effect of Yoga, Pranayam and Well being sessions on Pain Tolerance and Pain Threshold Levels in Normal Healthy Participants using the cold pressor technique 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sweta Salgaonkar 
Designation  Professor, Department of Anesthesiology, Seth GS Medical College and KEM Hospital 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Department of Anesthesiology, Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9869078541  
Fax    
Email  swetavs21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Darsita Jatakia 
Designation  Second year MBBS student 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9769169277  
Fax    
Email  mbbs200087@kem.edu  
 
Details of Contact Person
Public Query
 
Name  Darsita Jatakia 
Designation  Second year MBBS student 
Affiliation  Seth GS Medical College and KEM Hospital 
Address  Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  9769169277  
Fax    
Email  mbbs200087@kem.edu  
 
Source of Monetary or Material Support  
Research Society Seth G S Medical College and KEM Hospital 
 
Primary Sponsor  
Name  Research Society Seth G S Medical College and KEM Hospital 
Address  Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sweta Salgaonkar  Seth G S Medical College and KEM Hospital  Department of Physiology, Experimental lab, Theatre 3 and 5, Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 
09869078541

swetavs21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) Seth G S Medical College and KEM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Relief from Pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cold pressor technique   Cold pressor technique will be used to determine pain threshold values and pain tolerance levels by requiring a participant to place their bare non-dominant hand in cold water bath at 4°C for as long as they can. Once pain is present, they let researcher know. Once pain is unbearable, participant removes his/her hand. This provides a measure of threshold (first feeling pain) and tolerance (max time subject can keep their hand in cold water bath) All participants will be assessed at 3 assessment points: -baseline (T0) to assess baseline values, pre-intervention (before randomized allocation and before first Cold pressor trial) week 0 -Test 1(T1), 4 weeks, after intervention begins -Test 2 (T2) At end of study, after 8 weeks 4 batches will undergo different interventions after baseline assessment: - 1First Batch – Control It is a non-interventional group. They would be allowed to do reading/journal completion for 20 min to maintain homogeneity and also for comparison between four groups 2Second batch - Will be given Pranayama and yoga sessions for 20 min Yoga and pranayama sessions would include different permutations and combinations of 2 or 3 yoga asanas and pranayama each time. Yoga asanas to be included in intervention: Surya namaskar Pranayama that will be included in interventions Anulom vilom, Bhramari pranayama, Kapal Bhati pranayama, Bhastrika pranayama 3Third batch - Will attend 20 min wellbeing sessions for 8 weeks which would be conducted as interactive sessions on a few routine topics - Interpersonal relationships, Gratitude, Grit, Anger management, Time management, bouncing back, Stress management, Communication skills which would help participants in living a better life 4Fourth batch – Will be given a Combination of both Pranayama and yoga, and well-being sessions for 20 min each -Sessions would be taken on college campus after students complete their theory classes and practicals that are scheduled for that day -Complete procedure would be completed in 40-45 min -Yoga sessions would be carried out by Co-PI, Dr. Anita Agrawal who is a certified yoga trainer -Well-being sessions would be carried out by PI, Dr. Sweta Salgaonkar in lecture theatres of college building after due permission -In addition to that, participants of groups 2 and 4 would be asked to practice yoga for 20 min at their homes on other days of week also -Participants of group 3 would be asked to write reflections on session that was held in previous week and would be asked to implement life lessons covered in session in their day-to-day lives  
Comparator Agent  Reading/ Journal completion (Control group)   The Comparator/control is a non-interventional group. They would be allowed to do reading/journal completion for 20 minutes to maintain homogeneity and also for comparison between the four groups 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  1.Students who give their consent for the study.
2.MBBS Students of Seth GS Medical College of the age group of 18-21 years. 
 
ExclusionCriteria 
Details  1.Students who refuse to give their consent for the study.
2.Students who are suffering from any underlying illnesses
3.Students who have any open wounds, cuts, or fractures on their hand
4.Students suffering from migraine
5.Students who are non-cooperative with the researchers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Sociodemographic factors: Age, Sex, Non-Dominant hand measured through Percentage and Mean+- SD
2.Perception of Pain (as perceived by the subject): Perceived levels of pain,
Pain tolerance measured through Percentage Score on Likert scale  
0,1,2,3,4,5,6,7,8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effects of yoga and well being sessions on pain threshold levels in different genders

To assess the changes in blood pressure and heart rate before and after the cold pressor technique measured through Percentage and Mean SD 
0,1,2,3,4,5,6,7,8 weeks 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The International Association for the Study of Pain (IASP) has defined pain as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage". Pain is regarded as an extremely prevalent health issue in the world affecting thousands of people daily. 

Pain is known to occur in a variety of diseases that affect mankind, including cancer, rheumatoid arthritis, osteoarthritis, myocardial infarction, etc. Surgeries could also lead to chronic postoperative pain, eg: Invasive procedures like cardiac surgeries. Thus, pain is found to be extremely widespread, affecting different organs and tissues. Pain causes not only physical but also social, economic, and mental issues thus adversely affecting populations. 

Due to its high prevailing nature, many studies are being carried out to reduce pain. Though conventional methods are useful for treating pain, it has now been understood that alternative therapies also prove to be very useful in the treatment of pain especially chronic pain, and also in increasing pain tolerance.

 Yoga and pranayama are some of the ancient Eastern therapies that have long been proven helpful in easing down pain which include alignment of the mind with the soul. Yoga is also found to be useful in relieving chronic low back pain, menstrual pain, and other types of pain and thus is considered to be beneficial for pain management. On the other hand, well-being sessions include the dissemination of information on major professional and personal life skills.

A lot of studies have shown that short-term meditation (yoga and pranayama) has led to increased pain tolerance. But lesser studies have been undertaken on the comparison of yoga/pranayama sessions with well-being sessions.

So, our study mainly focuses on the benefits of yoga and pranayama and well-being sessions on pain; as also, compares the effects of yoga/pranayama to well-being sessions on the pain tolerance and pain threshold levels by experimentally inducing pain in healthy individuals.

 

 
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