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CTRI Number  CTRI/2020/12/029999 [Registered on: 23/12/2020] Trial Registered Prospectively
Last Modified On: 17/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   study on the effect OF music therapy and relaxation therapy in exam fear 
Scientific Title of Study   Comparative study on the effectiveness of Music Therapy and Progressive Muscular Relaxation in Chittodvega (Test Anxiety) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita Kishor Kale 
Designation  PG Scholar Department of Manovigyan evum Manasaroga 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Department of Manovigyan evum Manasaroga, OPD number 8 Thanniruhalla, B.M Road Hassan

Hassan
KARNATAKA
573201
India 
Phone  9422157545  
Fax    
Email  ankitakale2712@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suhas Kumar Shetty 
Designation  Professor and Head Department of Manovigyan evum Manasaroga 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Department of Manovigyan evum Manasaroga, OPD number 8 Thanniruhalla, B.M Road Hassan

Hassan
KARNATAKA
573201
India 
Phone  9449603234  
Fax    
Email  drsuhasshetty@sdmcahhassan.org  
 
Details of Contact Person
Public Query  
Name  Dr Suhas Kumar Shetty 
Designation  Professor and Head Department of Manovigyan evum Manasaroga 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Department of Manovigyan evum Manasaroga, OPD number 8 Thanniruhalla, B.M Road Hassan.

Hassan
KARNATAKA
573201
India 
Phone  9449603234  
Fax    
Email  drsuhasshetty@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, B.M Road Hassan 573201 Karnataka India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, B.M Road Hassan 573201 Karnataka India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR Ankita Kishor Kale  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  Department of Manovigyan evum Manasaroga, OPD number 8 BM Road, Thanniruhalla
Hassan
KARNATAKA 		 9422157545

ankitakale2712@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects between the age 18-30 years irrespective of gender and socioeconomic status. One month before exam time with signs and symptoms of test anxiety  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Music Therapy  Flute instrumental music - Raga desi-todi METHOD:Each participant will be explained about the influence of listening Indian music especially the Desi-todi raga which will be played on flute musical instrument by renowned flute musician Pandit Hariprasad Chaurasia and later they will be instructed to lie down comfortably in supine position, relaxed,focus mind on the recorded music, with closed eyes. TIMINGS:15 minutes in morning between 7am-10am DURATION:20 days  
Intervention  Progressive Muscular Relaxation  Each participant will be explained Progressive Muscular Relaxation technique which involves learning to monitor the tension in specific muscle groups. This tension is then released as attention is directed towards the differences felt during tension and relaxation. All subjects will made to listen a prerecorded tape instructing them in progressive muscular relaxation technique.Subjects will be given the following instructions: lie down comfortably in supine position,focus mind on the instructions, with closed eyesand perform accordingly. TIMINGS: 15 minutes in morning between 7am-10am DURATION:20 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1)One month before exam time with signs and symptoms of test anxiety will be selected.
2)Those subjects who are ready to sign informed consent form and be a part of study.
 
 
ExclusionCriteria 
Details  1)Prior history of psychiatric illness.
2)Subjects with known case of hearing disabilities.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of Music and Progressive Muscular Relaxation in Test anxiety.  20 days 
 
Secondary Outcome  
Outcome  TimePoints 
Westside Test Anxiety Score  20 Days 
 
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   N/A 
Date of First Enrollment (India)   01/01/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  


This study is a Randomized Open labeled double arm prospective clinical trial comparing the effectiveness of music therapy and progressive muscular relaxation in exam anxiety. Students residing in Hassan from different professions like Medical, Engineering, Nursing, and Ayurveda fulfilling the inclusion criteria will be selected for the study. Subjects will be assessed on 0th day (before treatment),on 21st that is after treatment(10daysbefore exam) and score will be Interpreted using Westside test anxiety scale. The aim of this research is that comparing both the therapies allows investigation of how relieved anxiety affects the exam performance and also which one of the therapies has more effect.


 
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