| CTRI Number |
CTRI/2025/03/083274 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Raga-Music Therapy and Cognitive Behavioral Therapy on Sleep Quality, Anxiety and Quality of Life among Anxiety induced Insomnia Patients. |
|
Scientific Title of Study
|
The Effect of Raga based Music Therapy and Cognitive Behavioral Therapy on Sleep Quality, Anxiety level and Quality of Life among patients with Moderate to Severe Anxiety induced Insomnia - A Randomized control 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 |
ELAKIYA S |
| Designation |
PhD Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Outpatient consultation room
2nd floor G block
Department of Psychiatry
Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9094233679 |
| Fax |
|
| Email |
u022401043@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.NATARAJAN S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Room no 11
A1 first floor
Medical Center
Department of Psychiatry
Sri Ramachandra Institute Of Higher Education and Research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9843730810 |
| Fax |
|
| Email |
natarajans@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
ELAKIYA S |
| Designation |
PhD Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) |
| Address |
Outpatient consultation room
2nd floor G block
Department of Psychiatry
Sri Ramachandra Institute of Higher Education and Research
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9094233679 |
| Fax |
|
| Email |
u022401043@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ELAKIYA S |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
Faculty of Behavioral and Social Sciences,
Porur, Chennai - 600 116
Tamil Nadu, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Elakiya S |
Sri Ramachandra Hospital ( G-Block) |
Department of Psychiatry, Out-Patient room,
Porur, Chennai.
Chennai
TAMIL NADU |
9094233679
-
u022401043@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Asusual medical treatment |
Patients in the control group will receive routine medical treatment including psychotropic medications and sleep hygiene counseling from the Psychiatrist. |
| Intervention |
Raga based Music therapy and Cognitive Behavioral therapy |
The Experimental group takes part in Raga-Music therapy and Cognitive-Behavioral Therapy (MT + CBT) with routine medical treatment including psychotropic medication while the control group will receive routine medical care with psychotropic medication. A pre-test using psychological assessments such as HAM-A for anxiety testing, Pittsburg sleep quality index for sleep quality, and WHOQOL_BREF for measuring quality of life is done. The experimental group will be exposed to 60 minutes of intervention at Psychiatry OP. Raga- music-based therapy followed by Cognitive behavioral therapy will be given during that time. Initiating the patients with breathing exercises and some relaxation techniques, recorded raga-based instrumental music will be played for 20 minutes, followed by a CBT session focusing on Cognitive Restructuring, Sleep Hygiene Education, Anxiety Management Techniques, and Relapse Prevention. Overall 8 sessions,1 session per week for 2 months will be given. During direct therapy sessions, Raga-based music therapy intervention is provided using laptops, and headphones with a volume range of 25-30db for 20 minutes.
A Raga-based instrument playlist will be instructed to the patients to hear 1 hour before going to sleep daily for 8 weeks until post-test results are collected. During a home-based intervention, participants are instructed to listen to the playlist mindfully in a relaxing posture by using a personal MP3 player on a mobile or laptop in an open space without any other noise focusing only on the soothing texture of the raga-based instrumental music with 70% of volume on everyday basis for 45 minutes. The participants were also instructed to maintain a log book and the PI will ensure the daily usage of this Music playlist by arranging for a G-meet/video call. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients experiencing insomnia due to anxiety disorder and who are on psychotropics.
Patients diagnosed with moderate and severe symptoms of Anxiety and Insomnia. |
|
| ExclusionCriteria |
| Details |
Patients with psychosis, substance abuse, adjustment disorders, and other psychiatric disorders will be excluded from the study. Patients with major medical or neurological co-existing conditions. Patients who are not interested in listening to raga-based instrument music. Patients with hearing deficit. Patients who are not willing to participate in the study will be excluded. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Sleep quality and reduction in Anxiety level of patients experiencing Insomnia due to Anxiety. |
Baseline Assessment (Pre-test), Intervention Phase and Follow-up Assessment (Post-test) will be done in the 10th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of life |
Baseline Assessment (Pre-test), Intervention Phase and Follow-up Assessment (Post-test) will be done in the 10th week. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/04/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Title: The Effect of Raga-Based Music Therapy and Cognitive Behavioral Therapy on Sleep Quality, Anxiety Levels, and Quality of Life Among Patients with Moderate to Severe Anxiety-Induced Insomnia “ A Randomized Control Study. Background and Objective:
Anxiety-induced insomnia significantly affects sleep quality, mental health, and overall quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a proven therapeutic intervention, while raga-based music therapy, rooted in Indian classical music, is emerging as a complementary approach. This study aims to evaluate the combined effects of these interventions on sleep quality, anxiety levels, and quality of life in patients with moderate to severe anxiety-induced insomnia. Methodology:
A randomized controlled trial (RCT) design will be employed. Patients meeting the inclusion criteria will be randomly assigned to two groups: experimental and control group. The Experimental group takes part in Raga-Music therapy and Cognitive-Behavioral therapy (MT + CBT) while the control group will receive routine medical care with psychotropic drugs. Outcome measures will include sleep quality (assessed using Pittsburgh Sleep Quality Index), anxiety levels (measured using the Hamilton Anxiety Rating Scale), and quality of life (evaluated through WHOQOL-BREF). Assessments will occur at baseline and post-intervention phases. This trial seeks to establish raga-based music therapy as an effective adjunctive treatment alongside CBT-I for managing anxiety-induced insomnia.
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