| CTRI Number |
CTRI/2025/12/099629 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Music therapy] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating music therapy to reduce anxiety in patients undergoing spinal anaesthesia for Orthopaedic Lower Limb Surgeries -A prospective randomized controlled study |
|
Scientific Title of Study
|
Evaluating music therapy as a perioperative anxiolytic in patients undergoing spinal anaesthesia for Orthopaedic Lower Limb Surgeries -A prospective randomized controlled 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 |
ALBIN KURIAKOSE |
| Designation |
Post graduate Student |
| Affiliation |
St. Johns Medical College and Hospital, Bangalore |
| Address |
Department of Anesthesiology St Johns Medical College and Hospital Sarjapur road Koramangala
Bengaluru-560034
Bangalore
KARNATAKA
560034
India |
| Phone |
08848041505 |
| Fax |
|
| Email |
albinparappattu1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moses Charles DSouza |
| Designation |
Professor and Head of Surgical and Neuro ICU |
| Affiliation |
St. Johns Medical College and Hospital, Bangalore |
| Address |
Department of Anesthesia and Critical Care St. Johns Medical College and Hospital.
Bengaluru-560034
Bangalore
KARNATAKA
560034
India |
| Phone |
7829000524 |
| Fax |
|
| Email |
moses.cd@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moses Charles DSouza |
| Designation |
Professor and Head of Surgical and Neuro ICU |
| Affiliation |
St. Johns Medical College and Hospital, Bangalore |
| Address |
Department of Anesthesia and Critical Care St. Johns Medical College and Hospital.
Bengaluru-560034
Bangalore
KARNATAKA
560034
India |
| Phone |
7829000524 |
| Fax |
|
| Email |
moses.cd@stjohns.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Critical Care St. Johns Medical College and Hospital. Bengaluru-560034 |
|
|
Primary Sponsor
|
| Name |
St.Johns Medical College and Hospital |
| Address |
Room no 7 OT Complex,2nd floor, St. Johns Medical College and Hospital, Sarjapur-Marathahalli Rd, beside Bank of Baroda, John Nagar, Koramangala Bengaluru-560034 |
| 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 |
| ALBIN KURIAKOSE |
St. Johns Medical College and Hospital |
Room No. 7 OT Complex, 2nd floor St. Johns Medical College and Hospital Sarjapur
road Koramangala
Bengaluru-560034
Bangalore
KARNATAKA |
8848041505
albinparappattu1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St Johns Academy of Health Sciences, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music Therapy |
Patients in the Music Therapy
Group (Group M with 25 patients) will listen to their preferred music( Selected by themselves on the day prior to surgery) through noise cancellation headphones
connected to mobile devices just after giving spinal anaesthesia. After the completion of surgery, the music therapy will be discontinued in group M |
| Comparator Agent |
Not giving music therapy |
Patients in the Group c will not listen to music through noise cancellation headphones after giving spinal anaesthesia during surgery
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiologists Classification: Patients classified as ASA Grade I or II.
2.Age: Patients under 18-59 years old.
3.Lower limb Orthopaedic surgical procedures performed in Supine position lasting for 3 hours or less
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Any Psychiatric illness or memory impairment.
3.Pregnancy
4.Hearing disability
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate music therapy as a perioperative anxiolytic in patients undergoing orthopaedic lower limb surgeries under spinal anaesthesia |
Patients anxiety levels will be assessed based on the Visual Analog Scale for Anxiety (VASA) score preoperatively 15 minutes before anesthesia, 30 min after spinal anesthesia and postoperatively 60
minutes after the surgical procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the impact of music therapy on:
1.Hemodynamic parameters
2.Pain intensity
3.Incidence of nausea and vomiting
4.Patient satisfaction
5.The requirement for rescue analgesics, anxiolytics, and antiemetics in patients undergoing spinal anaesthesia for orthopaedic lower limb surgeries
|
Patient’s hemodynamic parameters will be recorded preoperatively 15 min before spinal anaesthesia, every 15 minutes after spinal anaesthesia and post operatively after 60 min.
Pain will be assessed 60 min after surgery using VAS score.
Postoperative nausea vomiting will be assessed during the surgery and within first 24 hour after surgery
Overall patient satisfaction will be assessed postoperatively 60 min after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/01/2026 |
| 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="2"
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
|
Need
for Study
Anxiety is a pervasive concern for patients undergoing
orthopedic lower limb surgeries, potentially leading to increased stress,
discomfort, and analgesic requirements. Spinal anesthesia, although effective,
can provoke anxiety due to the unfamiliar environment, needle insertion, and
temporary loss of motor control. Current anxiolytic regimens often rely on
pharmacological interventions, which may have undesirable side effects.
Music therapy has emerged as a promising adjuvant
anxiolytic strategy, leveraging the calming effects of music to mitigate
anxiety. However, its efficacy in the context of spinal anesthesia for
orthopedic lower limb surgeries remains understudied.
This randomized controlled study aims to investigate
the anxiolytic effects of music therapy as an adjunct to standard care in
patients undergoing spinal anesthesia for orthopedic lower limb surgeries,
providing valuable insights into the potential benefits of this non pharmacological
intervention. Objectives
of Study: To evaluate music therapy as a
perioperative anxiolytic in patients undergoing orthopaedic lower limb
surgeries under spinal anaesthesia
|