| CTRI Number |
CTRI/2024/02/062347 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF MUSIC THERAPY VS GUIDED IMAGERY ON HEALTH CARE PROFESSIONAL STUDENTS WITH STRESS AND ANXIETY A RANDOMISED CLINICAL TRIAL |
|
Scientific Title of Study
|
EFFECT OF MUSIC THERAPY VS GUIDED IMAGERY ON HEALTH CARE PROFESSIONAL STUDENTS WITH STRESS AND ANXIETY- A RANDOMISED CLINICALL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Muragod |
| Designation |
MPT, PhD. Professor, HOD of Geriatric Physiotherapy, KAHER Institute of physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Sagar floor, Advanced Physiotherapy Center Room No 39 Dr
Prabhakar kore Hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Muragod |
| Designation |
MPT, PhD. Professor, HOD of Geriatric Physiotherapy, KAHER Institute of physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Sagar floor, Advanced Physiotherapy Center Room No 39 Dr
Prabhakar kore Hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmurgod@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jenisha Rajendra Dalal |
| Designation |
Physiotherapy Intern |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy, Nehru Nagar, Belgavi- Karnataka
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
7338180982 |
| Fax |
|
| Email |
jenishadalal01611@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education And Research |
| Address |
Nehru Nagar Belagavi, Karnataka. |
| 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 Anil Muragod |
KLE Prabhakar Kores Hospital |
Sagar floor, Advanced Physiotherapy Center Room No 39 Dr
Prabhakar kore Hospital and MRC, Belagavi
Belgaum
KARNATAKA
590010
India
Belgaum
KARNATAKA |
9164694970
anilmurgod@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress and Anxiety |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Guided Imagery |
Intervention: 3 weeks
Sessions : 4 times a week
Duration : 15 mins
Guided imagery exercise by C. Raudebaug will be given for 15 minutes
|
| Intervention |
Music Therapy |
Intervention : 3 weeks
Session : 4 times a week
Duration : 15 minutes
Music therapy will be given in a noise free room .
The music album “ the angels gift†by Peter Sterling will be played for 15 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
College going students.
Students of University campus colleges.
Students with both stress and anxiety.
Students with mild to moderate level of stress with a score of 10 to 26 according to perceived stress scale and/or mild to moderate level of anxiety with a score of 14 to 30 according to Hamilton Anxiety Scale.
|
|
| ExclusionCriteria |
| Details |
Students not willing to participate in the study.
Students with severe depression.
Students with psychiatric medications.
Students with hearing issues.
Recent tragic event.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perceived Stress Scale
|
T1- Week 0
T2- Week 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hamilton Anxiety Scale |
T1- Week 0
T2- Week 3 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
19/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Title:
Objective : To evaluate the effect of music therapy versus guided imagery in college going students with stress and anxiety using Perceived Stress Scale and Hamilton Anxiety Scale (HMA-A) respectively.
Inclusion Criteria: College going students (both male and females) of 19-30 years of age. Students of University campus colleges. Students with both stress and anxiety. Students with mild to moderate level of stress with a score of 10 to 26 according to perceived stress scale and/or mild to moderate level of anxiety with a score of 14 to 30 according to Hamilton Anxiety Scale.
Exclusion Criteria: Students not willing to participate in the study. Students with severe depression. Students with psychiatric medications. Students with hearing issues. Recent tragic event.
Outcome Measure: Perceived Stress Scale Hamilton Anxiety Scale
Procedure: Group A intervention will consist of Music Therapy and Group B will be given Guided Imagery. The intervention will last for 15 mins and effects will be assessed after 3 weeks. The intervention will be carried out for 4 Alternate days of the week for both the groups. |