| CTRI Number |
CTRI/2025/07/090785 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Thought behavioral therapy and mindfulness yoga: outcomes on body mind variables in female hockey players |
|
Scientific Title of Study
|
Cognitive behavioral therapy vs mindfulness yoga: outcomes on psychosomatic variables in female hockey athletes: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanalakshmi K |
| Designation |
Research Scholar |
| Affiliation |
SRM institute of science and technology |
| Address |
Directorate of Sports, SRM institute of science and technology, Kattankulathur, Chengalpattu District.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7448985875 |
| Fax |
|
| Email |
jesubalanrebecca@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhanalakshmi K |
| Designation |
Research Scholar |
| Affiliation |
SRM institute of science and technology |
| Address |
Directorate of Sports, SRM institute of science and technology, Kattankulathur, Chengalpattu District.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7448985875 |
| Fax |
|
| Email |
jesubalanrebecca@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayasingh Albert Chandrasekhar |
| Designation |
HOD, Associate professor |
| Affiliation |
SRM institute of science and technology |
| Address |
Directorate of Sports, SRM institute of science and technology, Kattankulathur, Chengalpattu District.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9043889551 |
| Fax |
|
| Email |
balajip880@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Institute of science and technology, Kattankulathur, chengalpattu district 603203. India. |
|
|
Primary Sponsor
|
| Name |
Dhanalaksshmi K |
| Address |
SRMIST,Kattangalathur, Chengalpattu, 603203 |
| 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 |
| Dhanalakshmi K |
SRM Institute of science and technology |
Room.No.101,Directorate of Sports, Department of Physical Education and Sports Sciences, Faculty of Science and Humanities, Kattankulathur, Chengalpattu 603203, India.
Chennai
TAMIL NADU |
7448985875
dk5523@srmist.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical college Hospital And Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Behavioral Therapy |
one hour, alternative 3 days per week.
Total duration of 12 weeks. |
| Intervention |
Mindfulness Yogic Practices |
one hour, alternative 3 days per week.
Total duration of 12 weeks. |
| Comparator Agent |
regular sports activity |
Total duration of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
College level women hockey players age range from 18 to 25 years only will be included.
Volunteers without any ailments and medication only will be included.
|
|
| ExclusionCriteria |
| Details |
Other age groups and other gender volunteers will be excluded from this study.
Volunteers having any ailments and medication will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To analyze the effects of mindfulness yogic practices on the selected psychosomatic variables such as cognitive anxiety, somatic anxiety, self-confidence and trauma among women hockey players.
•To analyze the effects of cognitive behavioral therapy on the selected psychosomatic variables such as cognitive anxiety, somatic anxiety, self-confidence and trauma among women hockey players.
|
12 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2025 |
| Date of Study Completion (India) |
27/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Group I (CBTG) will undergo Cognitive Behavioral Therapy Group, Group II (MYPG) will undergo Mindfulness Yogic Practices Group, Group III (CG) will function as a control group. Participants will be recruited from SRMIST, Kattankulathur (TN). The experimental groups will take part in the training for a period of twelve weeks to find out the outcome of the training packages, and the control group, who did not undergo any specific training during the experimental period of 12 weeks other than their regular practice in the curriculum. The CBTG will undergo cognitive behavioral therapy and MYPG will undergo mindfulness Yogic practices for one hour of practice a week at alternative 3 days for 12 weeks. Pre-test will be assessed in cognitive anxiety, somatic anxiety, self-confidence, trauma and sleep quality level will be assessed through Revised Competitive State Anxiety–2 (CSAI-2R), Childhood Trauma Questionnaire (CTQ-SF) and Athlete Sleep Screening Questionnaire (ASSQ) respectively. After 12 weeks of intervention, Post-test will be taken through the same questionnaires. All the data will be analyzed using statistical techniques and results will be concluded. |