| CTRI Number |
CTRI/2025/09/094160 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying how listening to special headphone music (binaural beats) can help reduce anxiety in people getting injections to numb the arm beforehand or shoulder surgery. |
|
Scientific Title of Study
|
The Effect Of Binaural Music Therapy On Anxiety In Patients Undergoing Peripheral Nerve Blocks For Upper Limb Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohammed C K |
| Designation |
Post Graduate Student |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
Ansari nagar West
New Delhi
South West
DELHI
110029
India |
| Phone |
9500862133 |
| Fax |
|
| Email |
ck.mohammed14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Banwait, MD |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
Ansari nagar West
New Delhi
South West
DELHI
110029
India |
| Phone |
9811783404 |
| Fax |
|
| Email |
sonalibanwait@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Banwait, MD |
| Designation |
Associate Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care
VMMC and Safdarjung Hospital
Ansari nagar West
New Delhi
South West
DELHI
110029
India |
| Phone |
9811783404 |
| Fax |
|
| Email |
sonalibanwait@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital
Ansari nagar West
New Delhi 110029 |
| Type of Sponsor |
Government 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 Mohammed C K |
VMMC and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care.
Ansari nagar West
New Delhi 110029
South West
DELHI |
9500862133
ck.mohammed14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC AND SAFDARJUNG HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BINAURAL MUSIC THERAPY |
Patients will wear over-the-ear headphones and listen to music embedded with binaural beats in the alpha frequency range (8–14 Hz) for 10 minutes before, during, and 10 minutes after the peripheral nerve block procedure. |
| Comparator Agent |
Control (Headphones without music) |
Patients will wear over-the-ear headphones with no music played for 10 minutes before, during, and 10 minutes after the peripheral nerve block procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients 18- 65 years of age, undergoing peripheral nerve blocks for upper limb surgery,
belonging to ASA physical status I and II. |
|
| ExclusionCriteria |
| Details |
Cognitive impairment and language difficulty
Patient on anti psychotic medication
Any problems with placement of headphones or hearing loss/auditory concern
Patients not able to read/write English language. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Binaural music therapy on anxiety in the patients undergoing peripheral nerve blocks for upper limb surgery, by using the VAS Anxiety score. |
10 minutes before the peripheral nerve block procedure
During the peripheral nerve block procedure
10 minutes after the peripheral nerve block procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To see the effect of Binaural music therapy on:
1.Anxiety in patients undergoing peripheral nerve blocks for upper limb surgery by using the Hamilton Anxiety Rating Scale
2. Perioperative hemodynamics like Heart rate and Blood Pressure. |
10 minutes before the peripheral nerve block procedure
During the peripheral nerve block procedure
10 minutes after the peripheral nerve block procedure
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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)
|
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 study aims to find out whether listening to special headphone music called binaural beats can reduce anxiety in patients before and during injections given to numb the arm for upper limb surgery. Adult patients between 18 and 65 years undergoing elective upper limb surgery under ultrasound-guided peripheral nerve block will be included. After providing written informed consent, participants will be randomly divided into two groups. One group will listen to music with binaural beats through headphones before and during the procedure. The other group will wear headphones without any music. Anxiety levels will be measured before and after the procedure using standard anxiety scales, and changes in vital signs will also be recorded. The study will help to see if binaural music therapy can provide a simple, safe, and non-drug method to reduce patient anxiety before surgery. |