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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  
Name  Address 
Nill  Nill 
 
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  
Status 
Not Applicable 
 
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.

 

 
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