| CTRI Number |
CTRI/2025/07/090019 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Music Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Ananda Bhairavi Raga to Reduce Anxiety in Claustrophobic Patients During MRI Scans – A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effectiveness Of Ananda Bhairavi Raga For Claustrophobic Patients Undergoing MRI: A Randomized Controlled 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 |
Gana Pilinja |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, NITTE DEEMED TO BE UNIVERSITY Deralkatte, Mangalore, Karnataka, India
Nitte Institute of Physiotherapy, NITTE DEEMED TO BE UNIVERSITY Deralkatte, Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9900315254 |
| Fax |
|
| Email |
gana.pilinja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Dhanesh Kumar KU |
| Designation |
Principal |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, NITTE DEEMED TO BE UNIVERSITY Deralkatte, Mangalore, Karnataka, India
Nitte Institute of Physiotherapy, NITTE DEEMED TO BE UNIVERSITY Deralkatte, Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Dhanesh Kumar KU |
| Designation |
Principal |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, NITTE DEEMED TO BE UNIVERSITY Deralkatte, Mangalore, Karnataka, India
Nitte Institute of Physiotherapy, NITTE DEEMED TO BE UNIVERSITY Deralkatte, Mangalore, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Study is not funded
Study is held at the MRI department of Justice K.S Hegde Hospital, Deralkatte, Mangalore |
|
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Primary Sponsor
|
| Name |
Nitte Deemed to be University |
| Address |
Nitte Institute of Physiotherapy, NITTE (DU), PO 12. Deralkatte, Mangalore - 575018 Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Gana Pilinja |
Dr Gana Pilinja |
Nitte Institute of Physiotherapy, NITTE DEEMED TO BE UNIVERSITY, Deralkatte, Mangalore- 575018 Karnataka, India
Dakshina Kannada
KARNATAKA |
09900315254
gana.pilinja@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of NITTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ananda Bhairavi Raga(Music Therapy) |
Intervention Name
Ananda Bhairavi Raga -Music Therapy
Type of Intervention
Behavioral or Non Pharmacological Music Therapy
Intervention Description
Participants in the intervention group will receive music therapy using instrumental compositions in Raga Ananda Bhairavi, an Indian classical raga known for its calming and anxiety reducing effects.
Procedure
1. Pre-MRI Preparation
Participants will perform a 10-minute guided deep breathing exercise in a quiet, dimly lit room to promote relaxation.
The breathing cycle includes
Inhale through the nose for 4 seconds
Hold the breath for 7 seconds
Exhale slowly through the mouth for 8 seconds
This cycle is repeated continuously for 10 minutes.
2. During MRI Scan
Participants will listen to pre-recorded instrumental compositions in Raga Ananda Bhairavi.
Compositions are by renowned Carnatic composers including Bhadrachala Ramadas, Tyagaraja, Shyama Shastri, and Muthuswami Dikshitar.
The music will be played for 40 minutes, and looped if the scan duration is longer.
Music is delivered via MRI-compatible headphones volume is adjusted remotely from the control room to be comfortably audible above scanner noise.
The bass and tempo of the music are pretested to ensure clarity and therapeutic benefit.
Participants are continuously monitored for comfort and will have access to an emergency alert button to signal any distress during the scan. |
| Comparator Agent |
Deep Breathing with No Music |
Comparator Agent Deep Breathing with No Music
Type of Comparator Behavioral or Non-Pharmacological – Relaxation without Music
Description of Comparator/Control Intervention
Participants in the control group undergo the same MRI procedure as the intervention group but without the music therapy component. Instead, they receive a non-auditory relaxation technique.
Procedure
1. Pre-MRI Preparation
Participants perform a 10-minute guided deep breathing exercise, identical to the intervention group, in a quiet, dimly lit room.
Breathing pattern
Inhale through the nose for 4 seconds
Hold the breath for 7 seconds
Exhale through the mouth for 8 seconds
This cycle is repeated continuously for 10 minutes to promote relaxation.
2. During MRI Scan
Participants do not receive music therapy.
They wear noise-canceling headphones or standard earplugs to minimize scanner noise, but no auditory stimulation is provided.
Comfort is monitored throughout the scan, and an emergency button is available for the participant to alert staff if needed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants may need to fall within a certain age range (e.g., 18-65 years old) for factors related to age and emotional regulation.
Patients must be able to understand the study and the informed consent to the participant will be given.
Participants must have their MRI procedure eligibility confirmed by the Department of Radiodiagnosis as patients must be eligible to undergo an MRI scan (e.g., no metal implants, pacemakers, or other contraindications).
Only participants undergoing MRI scans with the head end positioned inside the MRI machine will be considered for the study.
Any score or response from the pre-test anxiety and stress questionnaire will be considered for analysis, ensuring inclusion regardless of initial anxiety or stress levels.
Participants should not have taken sedatives or other medications that might alter the results of the anxiety or claustrophobia response during the MRI.
|
|
| ExclusionCriteria |
| Details |
Individuals with severe anxiety disorders (other than claustrophobia), mood disorders, psychosis, or intellectual disabilities might be excluded due to potential confounding factors.
Individuals who do not consent to participate or are unable to cooperate during the procedure will be excluded.
Pediatric patients and the patient who are unconscious are excluded.
Patients with Acute window stroke, and uncontrolled chronic illnesses, particularly those that might contraindicate MRI (e.g., severe cardiovascular or neurological conditions), would typically be excluded.
Individuals who are unable to hear the music (if it is auditory music therapy) would likely be excluded, as they would not be able to experience the intervention as intended.
Participants who have previously undergone an MRI scan or those scheduled for repeated scans will be excluded from the study.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Generalized Anxiety Disorder-7 (GAD-7) scale |
Primary Outcome:
Change in anxiety levels assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale.
Time Points:
Baseline (immediately before MRI scan)
Post-intervention (immediately after MRI scan)
Description
This outcome evaluates the effectiveness of Raga Ananda Bhairavi in reducing pre-procedural anxiety among claustrophobic patients by comparing anxiety scores before and after the MRI procedure.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Claustrophobia Questionnaire (CLQ) |
Outcome Name:
Change in Claustrophobic Symptoms
Measurement Tool:
Claustrophobia Questionnaire (CLQ)
Time Points
Baseline (immediately before MRI scan)
Post-intervention (immediately after MRI scan)
Description
Claustrophobic symptoms will be assessed using the CLQ, which evaluates fear of suffocation & restriction. Scores recorded before & after the MRI will help determine the immediate effect of the intervention on claustrophobic responses. |
| Visual Analogue Scale (VAS) |
Outcome Name
Self-Reported Anxiety & Comfort Levels
Measurement Tool
Visual Analogue Scale (VAS)
Time Points
Baseline immediately before MRI scan
Post-intervention immediately after MRI scan
Description
Self-reported anxiety & overall comfort will be assessed using the Visual Analogue Scale (VAS) to capture the participant’s subjective experience before & after the MRI scan. This will help evaluate the immediate emotional impact of the intervention |
| open-ended questions post-MRI |
Outcome Name:
Qualitative Feedback on MRI Experience
Measurement Tool:
Open-ended Questionnaire (Post-MRI)
Time Point:
Post-intervention (immediately after MRI scan)
Description:
Qualitative data will be collected through open-ended questions administered immediately after the MRI scan. This feedback aims to explore participants emotional, cognitive, & physical responses to the experience, particularly in relation to the music intervention. |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2025 |
| 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="0"
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
|
This randomized controlled trial aims to evaluate the effectiveness of Raga Ananda Bhairavi, an Indian classical raga, in reducing anxiety and claustrophobic symptoms among patients undergoing MRI. A total of 100 participants aged 18–65 years will be randomly assigned to either the intervention group, which receives music therapy using Raga Ananda Bhairavi during the MRI scan along with deep breathing exercises, or the control group, which practices deep breathing only without music. Anxiety levels will be measured using the Generalized Anxiety Disorder-7 (GAD-7) scale, claustrophobic symptoms with the Claustrophobia Questionnaire (CLQ), and subjective experience through the Visual Analogue Scale (VAS), both pre- and post-scan. Additional qualitative feedback will be collected via open-ended questions. The study aims to explore a safe, cost-effective, and culturally relevant non-pharmacological intervention to improve patient comfort, reduce anxiety-related scan terminations, and enhance the overall MRI experience. |