| CTRI Number |
CTRI/2025/07/090694 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
checking the sleep quality in traffic police officers |
|
Scientific Title of Study
|
Efficacy of brain gym exercises on quality of sleep and stress level in traffic police personnel |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Gagan Deep Singh |
| Designation |
Assistant Professor |
| Affiliation |
TDTR DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION,YAMUNA NAGAR |
| Address |
ROOM NO 1 DEPARTMENT OF NEUROLOGY TDTR DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION YAMUNANAGAR HARYANA ROOM NO 1, DEPARTMENT OF NEUROLOGY TDTR DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION YAMUNANAGAR HARYANA Yamunanagar HARYANA 135001 India |
| Phone |
9896918644 |
| Fax |
|
| Email |
drgagan150@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Gagan Deep Singh |
| Designation |
Assistant Professor |
| Affiliation |
TDTR DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION,YAMUNA NAGAR |
| Address |
ROOM NO 1 , DEPARTMENT OF NEUROLOGY TDTR DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION YAMUNANAGAR HARYANA ROOM NO 1 , DEPARTMENT OF NEUROLOGY TDTR DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION YAMUNANAGAR HARYANA Yamunanagar HARYANA 135001 India |
| Phone |
9896918644 |
| Fax |
|
| Email |
drgagan150@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Inderjeet |
| Designation |
Student MPT(Neurology) |
| Affiliation |
T D T R DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION,YAMUNA NAGAR,HARYANA |
| Address |
ROOM NO 1, DEPARTMENT OF NEUROLOGY TDTR DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION YAMUNANAGAR HARYANA ROOM NO 1, DEPARTMENT OF NEUROLOGY TDTR DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION YAMUNANAGAR HARYANA Yamunanagar HARYANA 135001 India |
| Phone |
7347464745 |
| Fax |
|
| Email |
ratheeinder@gmail.com |
|
|
Source of Monetary or Material Support
|
| Inderjeet(MPT student) room no.1,Department of neurology, T D T R DAV INSTITUTE OF PHYSIOTHERAPY AND REHABILITATION,YAMUNA NAGAR,HARYANA pin code 135001 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Inderjeet |
TDTR DAV institute of physiotherapy and rehabilitation |
ROOM NO 1, DEPARTMENT OF NEUROLOGY Yamunanagar HARYANA |
7347464745
ratheeinder@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee TDTR DAV Institute Of Physiotherapy And Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
in quality of sleep (insomnia) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Gym Exercises |
Procedure
Written consent will be obtained from all participants who meet the inclusion criteria. A pretest assessment will be conducted on the first day, followed by weekly follow-up assessments.
Assessment
Sleep quality will be measured using a validated tool such as the Pittsburgh Sleep Quality Index (PSQI).
Intervention
A 4-week Brain Gym exercise program will be implemented to enhance cognitive function, reduce stress, and promote relaxation.
Training
Participants will be trained to perform the exercises correctly before starting the program.
Session Duration
Each session will last 30 minutes, including rest breaks. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
1. Traffic police personnel working in Yamuna Nagar despite of their gender.
2. Non-smoking status, confirmed through self-reporting.
3. Age range (e.g., 18-58 years) to ensure participants are within the typical working age
range for traffic police personnel. Along with a scoring of 15 or more on insomnia severity
index.
4. Ability to understand perform the required set of exercise sets effectively.
5. Willingness to participate in the study and provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Participants are not included in the study who have any pre-existing respiratory
diseases (e.g., asthma, chronic obstructive pulmonary disease) that may counter-up
respiratory activity independently of occupational exposure.
2. Participants are exposed who have history of significant respiratory tract infection
4. Any co-morbidities or medical conditions that could affect the mental function.
5. Currently taking medications or treatments that could affect brain function.
6. Any participant who have any kind of trauma or fracture. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pittsburgh sleep quality index(PSQI) scale
2. insomnia severity index |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh sleep quality index (PSQI) scale |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
21/07/2025 |
| 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="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
The present study is designed to evaluate the efficacy of Brain Gym exercises on improving sleep quality and reducing stress levels among traffic police personnel stationed in Yamuna Nagar and Panchkula . Due to their constant exposure to long working hours, environmental stressors, and irregular schedules, traffic policemen are particularly vulnerable to poor sleep and heightened stress, which may negatively impact their health and job performance. Chronic stress and sleep disturbances can lead to reduced cognitive function, impaired decision-making, and overall diminished well-being. As mental fitness is vital for sustained occupational effectiveness, it is essential to assess and enhance sleep and stress parameters in this high-risk group. Brain Gym exercises, which involve simple movements aimed at enhancing brain-body coordination, may offer a feasible, non-pharmacological approach to address these issues. This study seeks to explore the potential benefits of these exercises as a practical intervention for improving psychological resilience and sleep health in traffic police personnel. |