| CTRI Number |
CTRI/2024/02/063135 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on psychological variables in athletes |
|
Scientific Title of Study
|
Effect of yoga practice on psychological correlates in young 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 |
Priyanka Saraswati |
| Designation |
Research Scholar |
| Affiliation |
IIT - (BHU) |
| Address |
Department of Humanistic Studies IIT-(BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
pakhis33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satish Kanaujia |
| Designation |
Assistant Professor |
| Affiliation |
IIT(BHU)- Varanasi |
| Address |
Department of Humanistic Studies IIT-(BHU) Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
919027216799 |
| Fax |
|
| Email |
skanaujia.hss@iitbhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Saraswati |
| Designation |
Research Scholar |
| Affiliation |
IIT - (BHU) |
| Address |
Department of Humanistic Studies IIT-(BHU
Department of Humanistic Studies IIT-(BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
919027216799 |
| Fax |
|
| Email |
pakhis33@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IITBHU - Indian Institute of Technology (BHU) Varanasi |
| Address |
IITBHU - Indian Institute of Technology (BHU) Varanasi |
| Type of Sponsor |
Other [] |
|
|
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 Bhuwan Chandra Kapri |
Banaras Hindu University, Varanasi, India |
Department of Physical Education, BHU, Varanasi
Varanasi
UTTAR PRADESH |
919450851042
dr.bckapri@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IMS - (BHU) |
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 |
No intervention |
| Intervention |
The Yogic intervention contains pranayama and meditation will be practiced for 45 min only by intervention group for 45 days. |
Preparation
Yogic Intervention Prayer
Skull Cleansing( Kapal Bhati) 2-3 min
Heating Pranayama (Ujjai & Bhastrika) 5-7 min
Cooling Pranayama (Sitli & Sitkari) 5-7 min
Alternate Nostril Breathing (Anulom Vilom) 6-7 min
Bee Breathing (Bhramari) 3-4 min
Meditation(OM Chanting) 5-7 min
Closing Prayer
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
recreational athletes from sports (curling, volleyball, Basketball, swimming, Football, cricket, wrestling, badminton, skating, Kabaddi tennis, and hockey) will be included. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria are a likely severe psychiatric disorder (schizophrenia, mania, bipolar disorders OCD), chronic illness (diabetes mellitus, hypertension, allergic asthma, tuberculosis.), endocrine or metabolic disorders (hypothyroidism or hyperthyroidism), substance abuse, disability, and history of using psychotropic drugs, and smoking, less than four hours of athletic training per week, previous experience with yoga or mindfulness training, or being younger than 18. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep quality and pattern |
After one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stress, anxiety, and sports performance in athletes. |
After one month |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/03/2024 |
| 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="1"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Psychological balance is related to mindfulness and yoga, and other behavioral therapies. Mindfulness
practices involve mind-body exercises such as yoga, focusing on learning awareness for listening
and responding to bodily stirs. This awareness
helps athletes enhance their psychological well-being and performance in
challenging situations. This study will
evaluate the effects of yoga practice on sleep quality, stress, anxiety, and sports performance in athletes. It will also explore the athletes’
compliance and acceptability of yoga practices.
If the study results benefit the athletes in improving their stress, anxiety, sleep, and, consecutively, their sports performance, the
practice can be used as a part of their routine sports practice.
|