| CTRI Number |
CTRI/2025/08/093747 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Better Sleep Habits Can Improve Strength, Reduce Anxiety, and Help Teenage Girls in Sports Recover Faster |
|
Scientific Title of Study
|
Impact of Sleep Hygiene Education on Strength, Competitive anxiety and Recovery In Adolescent Female Athletes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemlata |
| Designation |
PG Student |
| Affiliation |
Pt.BD Sharma PGIMS Rohtak |
| Address |
Physiotherapy Department, E block, College of Physiotherapy, PGIMS ROHTAK
Rohtak HARYANA 124001 India |
| Phone |
9996306097 |
| Fax |
|
| Email |
harsshujangra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Poonam Dhankher |
| Designation |
Associate Professor |
| Affiliation |
College of physiotherapy, Pt. BD Sharma University of Health Sciences, Rohtak |
| Address |
Faculty Room, Physiotherapy Department, E block, College of Physiotherapy, PGIMS ROHTAK
Rohtak HARYANA 124001 India |
| Phone |
8607157000 |
| Fax |
|
| Email |
Poonam.dhankher.jhajhria@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Hemlata |
| Designation |
PG Student |
| Affiliation |
Pt.BD Sharma PGIMS Rohtak |
| Address |
Physiotherapy Department, E block, College of Physiotherapy, PGIMS ROHTAK
Rohtak HARYANA 124001 India |
| Phone |
9996306097 |
| Fax |
|
| Email |
harsshujangra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.BD Sharma PGIMS ,Rohtak, Haryana,India-124001 |
|
|
Primary Sponsor
|
| Name |
College of physiotherapy, PGIMS ,Rohtak, Haryana,India-124001 |
| Address |
Pt. B.D. Sharma PGIMS, Rohtak, Haryana, India - 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Hemlata |
Pt. BD Sharma PGIMS Rohtak |
E block , College of Physiotherapy and Chaudhary Ranbir Singh new OPD, PGIMS ROHTAK Rohtak HARYANA |
09996306097
harsshujangra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee, PGIMS /UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General health and wellness education sessions |
Participants in the control group will attend general health and wellness education sessions, but will not receive specific sleep hygiene education. These sessions will cover importance of a balanced diet for recovery, hydration and its effects on muscle function, general stress management strategies and injury prevention techniques
|
| Intervention |
Sleep Hygiene Education |
Structured sleep hygiene education program will be administered for 7 weeks. Participants will also maintain a Consensus Sleep Diary-Core (CSD-C) to track their bedtime, wake time, and sleep disturbances.
Each session will conclude with a Q&A discussion to clarify doubts and reinforce concepts
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1 Female athletes actively competing at district state or national level in structured training programs
2 No history of diagnosed sleep disorder
3 Willing to comply with the study protocol and intervention procedures |
|
| ExclusionCriteria |
| Details |
1 Athletes with clinically diagnosed sleep disorders (e.g., insomnia, obstructive sleep apnea).
2 Athletes with psychiatric disorders (e.g., anxiety, depression) that may impact sleep patterns.
3 Athletes using medications that affect sleep patterns e.g. sedatives, stimulants
4 Athletes recovering from injuries sustained in the last three months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vertical Jump Test, Sports Anxiety Scale-2, Perceived Recovery Status Scale |
Baseline at week 0, post intervention week 7, follow up at week 12 and 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Yo-Yo test, T-test, Pittsburgh Sleep Quality Index (PSQI) |
Baseline at week 0, post intervention week 7, follow up at week 12 and 24 |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
05/09/2025 |
| 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)
|
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
|
Background
Sleep is a vital physiological process influencing physical recovery, hormonal regulation, cognitive function, and athletic performance. Adolescent female athletes are particularly vulnerable to poor sleep hygiene due to rigorous training schedules, academic responsibilities, social obligations, and psychological stress. Inadequate sleep in this population is associated with fatigue, slower reaction time, reduced strength and endurance, increased injury risk, and impaired recovery.
Sleep hygiene refers to behavioral and environmental practices that promote consistent and restorative sleep. Good sleep habits can optimize the anabolic hormonal environment necessary for post-exercise recovery, regulate mood, reduce anxiety, and improve performance. While nutritional and training interventions in athletes are well-studied, the impact of structured sleep hygiene education on athletic performance and psychological outcomes in adolescent female athletes remains underexplored.
Methodology
This study is a randomized controlled trial (RCT) conducted over a 12-month period with 60 female adolescent athletes aged 18–25 years, actively participating in competitive sports. Participants are randomly divided into two equal groups:
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Experimental Group (n=30): Receives a structured 7-week sleep hygiene education program covering topics such as sleep physiology, behavioral strategies, relaxation techniques (progressive muscle relaxation, paced breathing), and nutrition’s impact on sleep. Participants maintain a sleep diary and attend group sessions.
-
Control Group (n=30): Receives general health and wellness education without sleep-specific content.
Assessments are done at baseline (Week 0), immediately post-intervention (Week 7), and at follow-ups (Week 12 and Week 24) using validated tools:
-
Strength: Vertical Jump Test
-
Endurance: Yo-Yo Test
-
Competitive Anxiety: Sports Anxiety Scale-2 (SAS-2)
-
Recovery: Perceived Recovery Status (PRS) Scale
-
Agility: T-Test Agility Test
-
Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
Statistical analysis includes paired and independent t-tests, repeated measures ANOVA, and Pearson correlation, with significance set at p < 0.05.
Discussion
This study hypothesizes that structured sleep hygiene education will significantly enhance strength, improve recovery, and reduce competitive anxiety in female adolescent athletes compared to controls. By integrating educational sessions with practical interventions like relaxation exercises and personalized sleep routines, the study targets both intrinsic and extrinsic factors affecting sleep quality.
Expected outcomes include improved sleep patterns, better perceived recovery, reduced anxiety levels, and measurable improvements in athletic performance. The longitudinal design and use of validated outcome measures will allow for evaluating both immediate and sustained effects of the intervention.
The findings aim to bridge a research gap by highlighting sleep hygiene as a cost-effective, non-pharmacological tool for improving overall sports performance. If successful, the study could encourage coaches, physiotherapists, and sports institutions to incorporate sleep education into routine athletic training programs. |