| CTRI Number |
CTRI/2025/08/092868 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out if using noise-cancelling headphones during hip replacement surgery helps reduce pain after surgery |
|
Scientific Title of Study
|
Effect of noise cancellation headphones during total hip arthroplasty under spinal anaesthesia on postoperative pain; a randomized trial 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 |
Arun Prasannan |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number 415, BL Taneja Block, 4th Floor, Unit 3, Department of Anesthesiology, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8590501366 |
| Fax |
|
| Email |
arun.prasannan1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anju Romina Bhalotra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number 415, BL Taneja Block, 4th Floor, Unit 3, Department of Anesthesiology, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604219 |
| Fax |
|
| Email |
drakgk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Arun Prasannan |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number 415, BL Taneja Block, 4th Floor, Unit 3, Department of Anesthesiology, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8590501366 |
| Fax |
|
| Email |
arun.prasannan1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
JLN Marg, New Delhi, 110002 |
| 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 Arun Prasannan |
Lok Nayak Hospital |
Room Number 415, Unit 3, Department of Anesthesiology, BL Taneja Block, 4th Floor
Central
DELHI |
8590501366
arun.prasannan1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals, New Delhi |
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 |
| Comparator Agent |
No headphones (standard care) |
Spinal anaesthesia without headphones. |
| Intervention |
Noise cancellation headphones |
Spinal anaesthesia + noise-cancelling headphones till end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 to 65 years with American Society of Anaesthesiologists (ASA) physical status I to III. |
|
| ExclusionCriteria |
| Details |
Patients with hearing impairment or use of hearing aids; chronic pain syndromes or regular opioid analgesic use in the last three months; neurological disorders including dementia, Parkinson’s disease, or stroke; psychiatric illness such as major depression, schizophrenia, or severe anxiety; contraindications to spinal anaesthesia such as coagulopathy, infection at injection site, or spinal deformities; BMI greater than 35 kg/m²; uncontrolled cardiovascular disease such as severe hypertension, recent myocardial infarction, or heart failure. |
|
|
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 |
| Difference between mean of highest pain scores in the first 24 hours after surgery, measured using a 11-point numeric rating scale (NRS)in both groups. |
First 24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean post operative pain scores using NRS at 4, 8, 12, and 24 hours after surgery. |
4, 8, 12, and 24 hours after surgery. |
| Mean time to requirement of first postoperative analgesic. |
Within first 24 hours after surgery. |
| Mean analgesic consumption over first 24 hrs postoperatively. |
First 24 hours after surgery. |
| Mean duration of sensory blockade and motor blockade of spinal anaesthesia. |
From administration of spinal anaesthesia until complete recovery of sensory and motor function. |
| Mean quality of Recovery -15 (QoR- 15) scores at 24 hours. |
24 hours after surgery. |
| Mean intraoperative Bispectral Index Scores (BIS). |
During intraoperative period. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/09/2025 |
| 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 Applicable |
| 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
|
Single-blind, randomized controlled pilot study of 70 adults undergoing elective total hip arthroplasty under spinal anaesthesia to assess the effect of noise-cancellation headphones on postoperative pain. Primary outcome: highest NRS pain score in first 24 h. Secondary outcomes: pain scores at set intervals, time to first analgesic, total analgesic use, sensory/motor block duration, QoR-15 at 24 h, and intraoperative sedation. |