| CTRI Number |
CTRI/2025/08/093690 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Wet Sheet Pack on Sleep Quality among College Going Female Students |
|
Scientific Title of Study
|
Effect of Wet Sheet Pack on Sleep Quality among College going Female Students – A Randomized Controlled Trial |
| Trial Acronym |
WSPS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komal Kumari |
| Designation |
PG Scholar Clinical Naturopathy |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room No BS 22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9315998331 |
| Fax |
|
| Email |
komal.kumari14679@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saraswati Tewani |
| Designation |
Professor HOD Department of Naturopathy |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room No BS 22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9131588356 |
| Fax |
|
| Email |
jyotitewanimgps@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Komal Kumari |
| Designation |
PG Scholar Clinical Naturopathy |
| Affiliation |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women Room No BS 22 Department of Research Lake Road Bairagarh Bhopal
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9315998331 |
| Fax |
|
| Email |
komal.kumari14679@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Lake Road, Bairagarh, Bhopal, Madhya Pradesh- 462030 |
|
|
Primary Sponsor
|
| Name |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
| Address |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Lake Road, Bairagarh, Bhopal, Madhya Pradesh- 462030 |
| Type of Sponsor |
Private 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 |
| Dr Komal Kumari |
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women |
Room No BS 22 Department of Research Lake Road Bairagarh
Bhopal
MADHYA PRADESH |
9315998331
komal.kumari14679@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sant Hirdaram Medical College of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy female students associated with reduced quality of sleep. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sleep Hygiene Counselling |
Participants will receive counselling on healthy sleep habits |
| Intervention |
Wet Sheet Pack |
A total of 10 sessions will be administered over a period of 5 weeks, with an interval of 3 days between sessions.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1.College students
2.PSQI more than 5
3.Subjects willing to sign the informed consent.
4.Subjects willing to take wet sheet pack for 10 sessions
|
|
| ExclusionCriteria |
| Details |
1.Feeble or weak person
2.Psychological disorder or neurological disorder
3.Open wound, skin eruption
4.Those using conventional or alternative treatments for insomnia.
5.Participating in another ongoing researches.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep quality measured by Pittsburgh Sleep Quality Index (PSQI) |
Baseline (Day 0) and Post-intervention (5th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep duration, Sleep latency, habitual Sleep efficiency (PSQI Subscale) |
Baseline (Day 0) and Post-intervention (5th week) |
| Daytime Sleepiness measured by Epworth Sleepiness Scale(ESS) |
Baseline (Day 0) and Post-intervention (5th week) |
| Perceived Stress measured by Perceived Stress Scale(PSS) |
Baseline (Day 0) and Post-intervention (5th week) |
| Visuospatial working memory measured by Corsi Block Tapping Test |
Baseline (Day 0) and Post-intervention (5th week) |
| Health-related Quality of Life measured by SF-36 questionnaire |
Baseline (Day 0) and Post-intervention (5th week) |
| Body Mass Index (BMI) |
Baseline (Day 0) and Post-intervention (5th week) |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
15/09/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [komal.kumari14679@gmail.com].
- For how long will this data be available start date provided 14-11-2027 and end date provided 14-11-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Effect of Wet Sheet Pack on Sleep Quality among College going Female Students—A Randomized Controlled Trial
Sleep quality is a vital determinant of physical and mental health among the students and even adults, but students are often vulnerable to poor sleep due to academic stress and their irregular lifestyle. One of the hydrotherapeutic modality known to produce calming, sedative, and stress-relieving effects is the wet sheet pack. This study aims to evaluate the effect of wet sheet pack on sleep quality among college-going female students, allocated randomly to either the intervention group receiving 10 sessions of wet sheet pack or to the control group for sleep hygiene counselling. The primary outcome assesses sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include PSQI subscales (sleep duration, sleep latency, and habitual sleep efficiency), the Epworth Sleepiness Scale (ESS), the Perceived Stress Scale (PSS), the Corsi Block Tapping Test for measuring cognitive performance, Body Mass Index (BMI), and health-related quality of life by SF-36.
|