| CTRI Number |
CTRI/2026/03/105427 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Music Therapy and Patient Anxiety and Satisfaction Following Total Knee Arthroplasty |
|
Scientific Title of Study
|
Influence of Music Therapy on Perioperative Patient Anxiety Levels and Satisfaction Following Total Knee Arthroplasty |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roohi Reddy |
| Designation |
Arthroplasty Fellow |
| Affiliation |
Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals |
| Address |
KIMS - Sunshine Hospitals, Begumpet
Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500003
Hyderabad
TELANGANA
500003
India |
| Phone |
9949356960 |
| Fax |
|
| Email |
roohireddy1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Roohi Reddy |
| Designation |
Arthroplasty Fellow |
| Affiliation |
Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals |
| Address |
KIMS - Sunshine Hospitals, Begumpet
Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500003
TELANGANA
500003
India |
| Phone |
9949356960 |
| Fax |
|
| Email |
roohireddy1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Roohi Reddy |
| Designation |
Arthroplasty Fellow |
| Affiliation |
Sunshine Bone and Joint Institute, KIMS - Sunshine Hospitals |
| Address |
KIMS - Sunshine Hospitals, Begumpet
Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500003
TELANGANA
500003
India |
| Phone |
9949356960 |
| Fax |
|
| Email |
roohireddy1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| KIMS - Sunshine Hospitals, Begumpet |
|
|
Primary Sponsor
|
| Name |
KIMS Sunshine Hospital |
| Address |
Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500003 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Tarun Jayakumar |
KIMS-Sunshine Hospital |
Dept. of Orthopaedics, 1st floor, Metro Pillar No. C1327, beside Jamia Masjid, Prakash Nagar, Begumpet, Hyderabad, Telangana 500003
Hyderabad
TELANGANA |
9663365766
tarunjaykumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, KIMS-Sunshine Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Music therapy |
Music therapy given using headphones intra-operatively |
| Comparator Agent |
No Music therapy |
Routine surgical protocol |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing Unilateral Primary Total Knee Arthroplasty under Spinal Anaesthesia.
Age between 18 and 80 years.
|
|
| ExclusionCriteria |
| Details |
H/o Psychiatric disorders- Depression and Anxiety
Patients on sedatives and other sleep medications
H/o Alcohol use and Narcotic consumption
H/o previous Hip/Knee Surgeries
H/o previous intra-articular injection
H/o Deafness
B/L TKR requiring GA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Assess:
1. Patient anxiety- State-Trait Anxiety Inventory (STAI)
|
Pre-operative, Intra-operative, post-operative day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Sedation requirements during surgery (BIS index)
3. Postoperative satisfaction score ( 5 point scale)
4. Patient vitals
5. VAS score
6. Cortisol levels |
Pre-operative, Intra-operative, post-operative day 1 |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 4 |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="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
|
The operating room environment, especially for orthopedic procedures, and more specifically for joint replacement surgery, can be loud since hammers and drills are often used. The sound of an orthopedic oscillating saw can reach up to 105 decibels (db). With spinal anesthesia, patients are more aware of this noise, potentially adding to the anxiety and necessitating the administration of additional sedating medications. Music therapy is an effective non-pharmacologic intervention that is cost-effective, easy to implement, and customize. It has been shown to significantly alleviate anxiety and improve patient satisfaction. Several studies have shown that music therapy can inhibit stress, reducing anxiety and neurohormonal responses to psychological stress, as well as preoperative anxiety and postoperative pain. AIM: Aim of this study is to examine the effects of music therapy intraoperatively on patient anxiety and satisfaction in patients undergoing unilateral total knee arthroplasty. |