| CTRI Number |
CTRI/2025/02/079845 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Autonomous Sensory Meridian Response Combined with Bensons Relaxation Technique on Quality of Sleep and Sleep Related Fatigue Levels in Physiotherapy Students |
|
Scientific Title of Study
|
Effect of Autonomous Sensory Meridian Response(ASMR) Combined with Bensons Relaxation Technique on Quality of Sleep and Sleep Related Fatigue Levels in Physiotherapy Students: A Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Gite |
| Designation |
Intern |
| Affiliation |
Department of Kinesiotherapy and Movement Sciences, Dr. D. Y. Patil College of Physiotherapy. |
| Address |
Ground Floor,Dr. D.Y. Patil College of Physiotherapy, Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune. Ground Floor,Dr. D.Y. Patil College of Physiotherapy, Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune. Pune MAHARASHTRA 411018 India |
| Phone |
9763324365 |
| Fax |
|
| Email |
sakshiisachin@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Divya Gohil |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Physiotherapy, Dr D Y Patil Vidyapeeth, Pimpri, Pune. |
| Address |
THIRD FLOOR, KINESIOTHERAPY AND MOVEMENT SCIENCE DEPARTMENT, Dr. D.Y. Patil College of Physiotherapy, Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune.
Pune MAHARASHTRA 411018 India |
| Phone |
7767828290 |
| Fax |
|
| Email |
divyagohil28@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Divya Gohil |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Physiotherapy, Dr D Y Patil Vidyapeeth, Pimpri, Pune. |
| Address |
THIRD FLOOR, KINESIOTHERAPY AND MOVEMENT SCIENCE,Dr. D.Y. Patil College of Physiotherapy, Dr. D.Y. Patil Vidyapeeth, Pimpri, Pune.
Pune MAHARASHTRA 411018 India |
| Phone |
7767828290 |
| Fax |
|
| Email |
divyagohil28@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD, Dr D Y PATIL COLLEGE OF PHYSIOTHERAPY |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College Of Physiotherapy |
| Address |
Dr D Y Patil College of Physiotherapy, Dr D Y Patil Vidyapeeth, Pimpri, Pune-411018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Divya Gohil |
Dr D Y Patil College of Physiotherapy |
OUT PATIENT DEPARTMENT, GROUND FLOOR DEPARMENT, Dr. D. Y.Patil College Of Building. Pune MAHARASHTRA |
7767828290
divyagohil28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Sub-Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Poor sleep quality and physical fatigue |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autonomous Sensory Meridian Response(ASMR) |
The Autonomous Sensory Meridian Response(ASMR) is a sensory phenomenon, an effect of which is, that people get tingling sensations in reaction to audible stimuli which can cause sleep and is accompanied by a sense of comfort and calmness.
The participants will listen to the ASMR audio using a headphone device through their mobile phones right before bedtime for a period of 20 minutes regurarly for 7 days. |
| Comparator Agent |
Bensons Relaxation Technique |
Bensons Relaxation Technique is a basic relaxation method that emphasizes lowering stress while promoting relaxation.
There are four steps to it Choose a comfortable atmosphere, then focus on a word or a phrase, while relaxing the muscles and keep a calm attitude.
The participants will practice relaxation exercise in bed in a calm and comforatble environment while simultaneously listening to the ASMR audio for 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) University-enrolled Bachelor of Physiotherapy students and interns.
2) Students who have complaints of poor sleep quality.
3) Students who complain of sleep-related fatigue.
4) Between the ages of 18 to 25 years.
5) Receiving the proposed intervention.
|
|
| ExclusionCriteria |
| Details |
1. Any medical history that could compromise the quality of sleep.
2. Students using any drugs that may change their sleeping pattern.
3. Coffee intake before bedtime.
4. Heavy use of electronics right before sleeping.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Pittsburgh Sleep Quality Index(PSQI) |
2-time points
Pre-intervention and post one week of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Modified Fatigue Impact Scale(MFIS) |
2-time points
Pre-intervention and post one week of intervention |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
10/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" 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
|
The extensive impacts of sleep deprivation on academic performance, health, and general well-being make it a major cause for concern when it comes to physiotherapy students. Thus, there is a need to assist students improve their sleeping patterns by addressing the effects of sleep deprivation, which will also create a more encouraging and productive learning environment. The benefits of technology-mediated therapies for health and well-being are becoming more and more evident in the expanding field of digital mental health and health-tech research. Autonomous Sensory Meridian Response (ASMR) interventions are particularly accessible to younger individuals who are regular users of social media. Bensons’ Relaxation technique is an evidence-based method for enhancing the quality of sleep. It has been shown to reduce stress and improve relaxation, potentially enhancing sleep quality. However, its effectiveness in combination with other methods like Autonomous Sensory Meridian Response (ASMR) is not well-explored. Research explicitly looking at the joint effects of ASMR and Benson’s Relaxation Technique on fatigue levels and quality of sleep in physiotherapy students is limited. The majority of studies concentrate on these treatments alone. Thus by combining the unique application of Autonomous Sensory Meridian Response with Bensons’ Relaxation technique, the study will address both the physical and psychological aspects of exhaustion and thus give better outcomes when compared with the individual approaches. This study supports larger educational and health goals to support student wellness, which is in line with the growing understanding of the significance of mental and physical health for academic performance. Future research will be supported by the unique treatment strategy addressing a major void in the literature. The study might also offer practical recommendations for incorporating these methods into wellness programs for students, which may improve their general academic and clinical outcomes. |