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
|
|
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
|
|
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. |