| CTRI Number |
CTRI/2026/01/100134 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
“Can Craniosacral Therapy Improve Stress Management and Performance in Competitive Shooters? A Randomised Sham-Controlled Study”
|
|
Scientific Title of Study
|
A Randomized Sham-controlled Trial to see the Impact of Craniosacral therapy on Stress-Coping and Performance in Shooters |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishita Ayla Sona |
| Designation |
PG Scholar |
| Affiliation |
Jaipur National University |
| Address |
Near New RTO Office, Jagatpura, Jaipur department of physiotherapy division- sports and orthopedics, room 02
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302017
India |
| Phone |
7000058519 |
| Fax |
|
| Email |
nishitasona123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Atul Singh(PT) |
| Designation |
HOD, Physiotherapy Department |
| Affiliation |
Jaipur National University |
| Address |
Near New RTO Office, Jagatpura, Jaipur department of physiotherapy division- sports and orthopedics, room 02
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302017
India |
| Phone |
9782468066 |
| Fax |
|
| Email |
hod.physiotherapy@jnujaipur.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arushi Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Jaipur National University |
| Address |
Near New RTO Office, Jagatpura, Jaipur department of physiotherapy division- sports and orthopedics, room 02
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302017
India |
| Phone |
9664389674 |
| Fax |
|
| Email |
arushi.saxena@jnujaipur.ac.in |
|
|
Source of Monetary or Material Support
|
| Jaipur National University,Near New RTO Office, Jagatpura, Jaipur department of physiotherapy division- sports and orthopedics, room 02
Jaipur
RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
Jaipur National University |
| Address |
Near New RTO Office, Jagatpura, Jaipur department of physiotherapy division- sports and orthopedics, room 02
Jaipur
RAJASTHAN |
| Type of Sponsor |
Other [self-sponsored] |
|
|
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 |
| Nishita Ayla Sona |
Jaipur National University |
Near New RTO Office, Jagatpura,Jaipur
Jaipur
RAJASTHAN |
7000058519
nishitasona123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jaipur National University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Competition related Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Craniosacral Therapy
|
its an hands on manual therapy approach for assessing and managing the craniosacral system
Given for 6 weeks |
| Comparator Agent |
Sham Therapy |
its a placebo therapy designed to mimic any real therapy to assess its effectiveness
Given for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Athletes Specializing in Shooting at professional level
Athletes engaging in high intensity sports with increased competition Anxiety |
|
| ExclusionCriteria |
| Details |
Athletes undertaking any medications
Athletes who engage in any other sports
Athletes undergoing other physical therapy interventions
Athletes participating in sports as recreational Activity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CSAI-2 |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shooting Accuracy Score |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This randomized sham-controlled trial aims to evaluate the effect of Craniosacral Therapy on stress coping and performance in competitive shooters. Forty athletes will be randomly allocated to receive either Craniosacral Therapy or Sham Therapy for six weeks. Stress levels will be assessed using the Competitive State Anxiety Inventory-2, and performance will be evaluated using shooting accuracy scores. The study aims to determine whether Craniosacral Therapy is an effective non-invasive intervention for improving stress management and performance in shooters. |