| CTRI Number |
CTRI/2024/09/074011 [Registered on: 18/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [physiotherapy including yoga and emotional intelligence training] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How yoga and emotional intelligence training can reduce stress and improve problem solving skills in physiotherapy students |
|
Scientific Title of Study
|
Effect of Emotional Intelligence Training with Yoga Training on perceived stress and problem-solving skills in Physiotherapy students – An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pushpak Patil |
| Designation |
mpt student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
room no 309 3rd floor Parul institute of physiotherapy (PIPT), Parul university Limda Waghodia Vadodara GUJARAT
391760 India
Vadodara GUJARAT 391760 India |
| Phone |
9359652655 |
| Fax |
391760 |
| Email |
pushpakpatil6437@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DRChaitali Shah |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Physiotherapy. |
| Address |
room no 309 3rd floor Parul institute of physiotherapy (PIPT), Parul university Limda Waghodia Vadodara GUJARAT
391760 India
Vadodara GUJARAT 391760 India |
| Phone |
9998107262 |
| Fax |
|
| Email |
2307202020005@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
DRChaitali Shah |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Physiotherapy. |
| Address |
room no 309 3rd floor Parul institute of physiotherapy (PIPT), Parul university Limda Waghodia Vadodara GUJARAT
391760 India
Vadodara GUJARAT 391760 India |
| Phone |
9998107262 |
| Fax |
|
| Email |
2307202020005@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul institute of physiotherapy, Parul university, Limda, Vadodara, Gujarat 391760 India |
|
|
Primary Sponsor
|
| Name |
Pushpak Patil |
| Address |
room no 309 3rd floor Parul institute of physiotherapy (PIPT), Parul university Limda Waghodia Vadodara GUJARAT
391760 India
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| pushpak patil |
Parul institute of physiotherapy |
room no 309 3rd floor Parul institute of physiotherapy (PIPT), Parul university Limda Waghodia Vadodara GUJARAT
391760 India
Vadodara GUJARAT |
9359652655
pushpakpatil6437@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
perceived stress and problem-solving skills |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Emotional intelligence training with yoga training |
1) Emotional intelligence training
Introduction to emotional intelligence and getting acquainted with its concepts
Training on emotional self-awareness
Teaching self-expression, assertiveness, and decision-making skills
Instruction on methods to enhance self-confidence and self-esteem
Training on self-fulfillment, personal growth, and self-motivation
Teaching emotional intelligence to manage stress
Training on controlling negative emotions and fostering positive thinking
Instructions on Building Intimate Interpersonal Relationships and Empathy
Problem-solving training.
Emotional intelligence training given for 35 minute 3 days per week for 12 sessions.
Along with emotional intelligence training physical therapy exercises are given in each session to
improve emotional intelligence, exercises are following:
A. Deep breathing exercise,10 reps for every session for 5 minutes
B. Jacobson’s relaxation techniques
2) yoga exercises
A) Meditation for 2 min
B) Pranayama- anulom vilom for 2.5 minute and Kapalbhati for 2.5 minute
C) Asanas-
1.siddhasana
2.Paschimottasansa
3.Gomukhasana
4.Kandhasana
5.Pawanmuktasana
6.Tadasana
7.Trikonasana
D) Cool Down
Shawasana for 2 minutes
Yoga exercises given for 30 min. 3 days per week 12 session.
|
| Comparator Agent |
yoga training |
yoga exercises
A) Meditation for 2 min
B) Pranayama- anulom vilom for 2.5 minute and Kapalbhati for 2.5 minute
C) Asanas- 1.siddhasana 2.Paschimottasansa 3.Gomukhasana 4.Kandhasana 5.Pawanmuktasana 6.Tadasana 7.Trikonasana
D) Cool Down Shawasana for 2 minutes
Yoga exercises given for 30 min. 3 days per week 12 session. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Students those who are willing to participate
Both male and female
Students having moderate to high perceived stress
Student with low problem-solving skills
Students with Low to very Low Ravens matrices score
1st to 4th year physiotherapy students
|
|
| ExclusionCriteria |
| Details |
Any physical and mental illness.
Any student’s close relative death in last month.
Tightness which will not restrict any functional activity
|
|
|
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 |
Problem Solving Style Questionnaire
Perceived Stress Scale |
4-week,3 days per week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ravens Progressive Matrices Test. |
4-week,3 days per week |
|
|
Target Sample Size
|
Total Sample Size="84" Sample Size from India="84"
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)
|
18/09/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Medical students face multiple demands including high expectation and potential liability. Recent international meta-analysis showed that more than 25% medical student experience symptom of depression. Fear of examination, high parental expectation, relationship problems, home sickness and aspiration of higher studies are factors to develop stress, low emotional intelligence and less problem-solving skills. In previous study it was found that 33.6% of 1st year medical college students were poor in all domains of the emotional intelligence and problem-solving skills. There are very few studies on emotional intelligence and problem-solving skills in Physiotherapy students. Emotional events can affect intellectual processor through how it enters emotion to cognitive system and change knowledge so it is used as part of cognitive process such as problem solving and decision making so while developing emotional intelligence skills it boosts ability to manage emotion when problem solving so that People with high EI significantly solve problems better than people with low EI. Yoga exercises reduces stress and improve problem solving skill by reducing sympathetic activation and increasing vagal activity so that it leads to decrease in cortisol and HPA axis activation occur there is improvement in neuroendocrinal activity, positivity, compassion and mindful adjustment. |