| CTRI Number |
CTRI/2025/07/091903 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of binaural beat music and active noise cancellation on anxiety in laproscopic cholecystectomy in patients under GA |
|
Scientific Title of Study
|
To assess the effects of binaural beat music and active noise cancellation on anxiety and intraoperative anaesthetic requirements in patients undergoing laproscopic cholecystectomy under general anaesthesia. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nipunika Agrawal |
| Designation |
Postgraduate resident |
| Affiliation |
Himalayan Institute Of Medical Sciences |
| Address |
Department of Anaesthesia
Himalayan institute of medical sciences Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
6394147763 |
| Fax |
|
| Email |
Nipunika7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya Gupta |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Himalayan institute of medical sciences
Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9456570288 |
| Fax |
|
| Email |
Divyagupta@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Divya Gupta |
| Designation |
Professor |
| Affiliation |
Himalayan Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Himalayan institute of medical sciences
Dehradun
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9456570288 |
| Fax |
|
| Email |
Divyagupta@srhu.edu.in |
|
|
Source of Monetary or Material Support
|
| Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly grant, Dehradun |
|
|
Primary Sponsor
|
| Name |
Swami Rama Himalayan University |
| Address |
Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun, 248140 |
| 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 |
| Dr Divya Gupta |
Himalayan institute of medical sciences |
1st floor department of Anaesthesiology, main building, Himalayan institute of medical sciences, Swami Rama Himalayan university Dehradun UTTARAKHAND
Dehradun
UTTARANCHAL |
9456570288
Divyagupta@srhu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Board, SRHU, jolly grant , Dehradun |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active noise cancellation |
Headphones attached with active noise cancellation only with general anesthesia |
| Comparator Agent |
Music with noise cancellation |
Headphones attached with Active noise cancellation with binaural beat music with general anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Either sex, patients in age group of 18 to 60 years, ASA grade 1 or 2, undergoing elective laproscopic cholecystectomy requiring general anaesthesia with LMA insertion, duration of surgery to be less than 120 minutes. |
|
| ExclusionCriteria |
| Details |
ASA grade 3 or 4, patients less than 18 and more than 60 years, history of any psychiatric illness, patients with active URTI, MPG grade 3 or 4, anticipated difficult airway, obesity with BMI more than 30, patients with any ear deformity, infection, vertigo, tinnitus, hearing loss,
Patients with significant cardiovascular and respiratory diseases and renal diseases
Patients with GERD, pregnancy , cervical spine pathology
Patient giving negative consent for research |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare effects of music and noise cancellation on intra operative anaesthetic drug requirements and post operative analgesic needs. |
1- immediately after attachment of headphones after induction.
2-immediately before creation of pneumoperitoneum
3- throughout pneumoperitoneum
4-immediately before extubation
5- after extubation.
6- first call for need of analgesics |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effects of music on anxiety relief |
State trait anxiety inventory-6 score calculation both preoperatively and post operatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
11/08/2025 |
| 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="7"
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
|
Preoperative anxiety is a common concern among surgical patients and can lead to increase anaesthetic requirements, delayed recovery and heightened peri operative complications. The topic investigates the effect of binaural beat music and active noise cancellation on anxiety levels and anaesthetic requirements in patients undergoing laproscopic cholecystectomy under general anaesthesia. The aim is to determine whether these non pharmacological interventions can reduce postoperative anxiety and lower intraoperative anaesthetic consumption, potentially improving patient outcomes and enhancing perioperative care.
Aim and objective- 1- to compare the effects of music with noise cancellation v/s active noise cancellation on intra operative anaesthetic drug requirements as well as post operative analgesic requirements on patients undergoing laproscopic cholecystectomy under general anaesthesia. 2- to assess the effects of music with noise cancellation and active noise cancellation on the anxiety relief in each group of patients undergoing laparoscopic cholecystectomy under general anesthesia. |