| CTRI Number |
CTRI/2024/09/074469 [Registered on: 27/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study if applying headphones on the patient to remove all background sounds during surgery reduces the postoperative pain experienced after laproscopic cholecystectomy |
|
Scientific Title of Study
|
Effect of noise cancellation using noise cancelling
headphones during laparoscopic cholecystectomy on postoperative pain |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V VIMALANATHAN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 303, BL Taneja Block, 3rd Floor, Department of
Anaesthesia, Maulana Azad Medical College
Central DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
8754124900 |
| Fax |
|
| Email |
vymalanath96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anju Romina Bhalotra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 303, BL Taneja Block, 3rd Floor, Department of
Anaesthesia, Maulana Azad Medical College
Central
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
9968604219 |
| Fax |
|
| Email |
drakgk@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vimalanathan v |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 303, BL Taneja Block, 3rd Floor, Department of
Anaesthesia, Maulana Azad Medical College
Central DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
8754124900 |
| Fax |
|
| Email |
vymalanath96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar 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 V Vimalanathan |
Lok Nayak Hospital |
Room No. 303, BL Taneja Block, 3rd Floor, Department of
Anaesthesia, Maulana Azad Medical College Central DELHI 110002
India
Central
DELHI |
8754124900
vymalanath96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maulana Azad Medical College |
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 |
Application of noise cancelling headphones intraoperatively during laproscopic cholecystectomy under general anaesthesia |
Noise cancelling headphones will be applied after induction of general anaesthesia but before surgery starts.The headphones will be removed after awakening the patient just before removal of airway device. |
| Comparator Agent |
No application of noise cancelling headphones intra operatively during laproscopic cholecystectomy under general anaesthesia |
No noise cancelling headphones will be applied after induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients between the age of 18 to 65 years of age scheduled to undergo elective laproscopic cholecystectomy under general
anaesthesia.
2.American Society of Anesthesiologists (ASA)
physical status 1,2,3 |
|
| ExclusionCriteria |
| Details |
1. Hearing abnormalities.
2. Preoperative chronic pain or long-term use of pain medications.
3. History of alcohol or psychoactive drugs use. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Movement evoked pain scores using numerical rating scale(NRS) in both study groups. |
Arrival in PACU
6 hours of surgery
12 hours of surgery
24 hours of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Resting pain score using numerical rating scale (NRS) in both study groups
2) Duration of analgesia given after surgery in both study groups
3)Total analgesic consumption in both study groups
4)Quality of recovery-15
(QoR-15)score |
1)Arrival in PACU,6 hours of surgery,12 hours of surgery,24 hours of surgery
2)First requirement of post operative analgesia will be noted
3)Within 24 hours after surgery
4)At 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
21/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Proposals should be directed to vymalanath96@gmail.com
- For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
we are comparing post operative pain scores in patients between the age group 18 to 65 years who had undergone elective laproscopic cholecystectomy with and without noise cancelling headphones. Aim of the study is to study the effect of noise cancellation using noise cancelling headphones during laproscopic cholecystectectomy on post operative pain ,taking a total sample size of 50 , 25 in each group |