| CTRI Number |
CTRI/2025/04/083801 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [music therapy ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to check the effect of music to relieve anxiety in patients during surgical procedures. |
|
Scientific Title of Study
|
Exploring the therapeutic influence of music on preoperative and
intraoperative anxiety and vital signs under spinal anesthesia. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patel Shivangi |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
310, GMERS Medical College, Majewadi gate Junagadh.
310, GMERS Medical College, Majewadi gate Junagadh.
Junagadh
GUJARAT
362001
India |
| Phone |
9408575739 |
| Fax |
|
| Email |
shivangipatel133@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Patel Shivangi |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
310, GMERS Medical College, Majewadi gate Junagadh.
310, GMERS Medical College, Majewadi gate Junagadh.
GUJARAT
362001
India |
| Phone |
9408575739 |
| Fax |
|
| Email |
shivangipatel133@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Patel Shivangi |
| Designation |
Assistant professor |
| Affiliation |
GMERS Medical College Junagadh |
| Address |
310, GMERS Medical College, Majewadi gate Junagadh.
310, GMERS Medical College, Majewadi gate Junagadh.
GUJARAT
362001
India |
| Phone |
9408575739 |
| Fax |
|
| Email |
shivangipatel133@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College Junagadh |
|
|
Primary Sponsor
|
| Name |
Dr. Shivangi Patel |
| Address |
87/88 street 4, raijinagar, Junagadh. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivangi Patel |
Gynec operation theatre |
407, forth floor, GMERS Medical College, Majewadi gate, Junagadh.
Junagadh
GUJARAT |
9508575739
shivangipatel133@gmail.com |
| Dr Shivangi Patel |
Surgical Operation Theatre |
307, Third floor, GMERS Medical College, Majewadi gate Junagadh.
Junagadh
GUJARAT |
9408575739
shivangipatel133@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, GMERS Medical College,Junagadh. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional care |
patients will not be provided with music therapy. |
| Intervention |
music therapy for 30 minutes preoperatively |
pt will be provided with muscic of their choice preoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Both |
| Details |
1. elective cases
2. asa 1-2
3. patients giving consent |
|
| ExclusionCriteria |
| Details |
• 1. patient refusal
• 2. suffering from or with a history of any psychiatric disorder
• 3. deaf or hearing impaired patients
• 4. patients who are unable to communicate.
• 5.any known hepatic, renal, cardiac, or respiratory diseases
• 6. any previous history of exposure to anaesthesia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation of effectiveness of music therapy in reducing anxiety |
VASA score at0, 30 and 60 minutes after initiation of procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare haemodynamic parameters between 2 groups |
heart rate & blood pressure at 0,30 & 60 minutes after initiation of procedure. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
11/04/2025 |
| 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="0"
Months="2"
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 evaluates effectiveness of music to relieve anxiety perioperatively an its effect on various vitals of patients like blood pressure and heartrate as to check does music has any soothing effects or not ! |