| CTRI Number |
CTRI/2025/07/090982 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Binaural Beat Music and Noise Cancelling Headphones to Reduce Anxiety During Surgery Under Spinal Anaesthesia"
|
|
Scientific Title of Study
|
Comparing Binaural Beat Music and Noise Cancelling Headphones
for reducing intraoperative anxiety in patients undergoing
surgery under spinal anaesthesia - A 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 |
Navya G |
| Designation |
Postgraduate |
| Affiliation |
Ballari medical College and research centre Ballari |
| Address |
Navya G
1st year Junior resident
Department of Anaesthesia
Contonment
Ballari medical College and research centre Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9606419082 |
| Fax |
|
| Email |
navyag2603@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothsna M |
| Designation |
Professor |
| Affiliation |
Ballari medical College and research centre Ballari |
| Address |
Dr Jyothsna M
Department of Anaesthesia
Contonment
Ballari medical College and research centre Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9900055996 |
| Fax |
|
| Email |
jyothsnabk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyothsna M |
| Designation |
Professor |
| Affiliation |
Ballari medical College and research centre Ballari |
| Address |
Dr Jyothsna M
Department of Anaesthesia
Contonment
Ballari medical College and research centre Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9900055996 |
| Fax |
|
| Email |
jyothsnabk@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Ballari medical College and research centre Ballari |
| Nil |
|
|
Primary Sponsor
|
| Name |
Ballari Medical College and research centre Ballari |
| Address |
Ballari Medical College and Research Centre
OT Complex
Contonment
Ballari 583104
Karnataka state
India 91 |
| 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 Navya G |
Ballari Medical College and Research Centre |
BMCRC
Department of Anaesthesiology
OT complex
Contonment
Ballari
583104
Karnataka
Bellary
KARNATAKA |
9606419082
navyag2603@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Ballari medical College and research centre, Ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K37||Unspecified appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Binaural beat music |
Duration 1 to 2 hrs
Headphones with music |
| Intervention |
Noice cancellation |
Duration 1 to 2 hrs
Headphones without music |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing lower abdominal surgery under spinal anaesthesia
ASA 1 and 2
Age 18-60 yrs
Male and Female gender
Patients able to provide written and informed consent |
|
| ExclusionCriteria |
| Details |
Patients with hearing impairment
Pre-existing psychiatric or neurological disorders.
Contraindications to spinal anaesthesia
Pregnant and lactating mother
Patients with chronic use of anxiolytics and sedatives |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of change in intraoperative anxiety levels |
30min after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperatively
Sedation
Ramsay score will used to monitor sedation, also any need for rescue sedation during surgery (e.g., midazolam, propofol) will be noted with dosage & frequency.
Hemodynamic Parameters
Heart rate, systolic/diastolic blood pressure
Measured at baseline & intraoperatively at regular intervals (e.g., every 10 minutes) Used as physiological indicators of anxiety
Communication
Patients communication intraoperatively is monitored using Likert score Postoperatively
Satisfaction
Postoperative satisfaction survey regarding intraoperative experience is assessed using VAS-S score
Incidence of Adverse Effects
Dizziness, discomfort due to headphones/music
Nausea, vomiting, or auditory disturbances |
Preoperatively baseline
Intraoperative 10min 20min 30min 40min 60min 80min 100min 120min
Postoperatively |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/08/2025 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [navyag2603@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 31-08-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The study will include adult patients of either gender, aged 18 to 60 years, with ASA physical status I or II, scheduled for lower abdominal surgeries under spinal anaesthesia. Patients with hearing impairment, psychiatric or neurological disorders, contraindications to spinal anaesthesia, and pregnant or lactating women will be excluded.
Participants will be randomly assigned to one of two groups: Group N (noise-cancelling headphones without music) or Group B (binaural beat music through headphones). Randomisation will be done using computer-generated numbers and allocation will follow the sequentially numbered opaque sealed envelope technique. Patients will be blinded to the intervention.
During preanaesthetic evaluation, patients will be briefed about the interventions, and baseline vitals along with STAI-6 anxiety scores will be recorded. Spinal anaesthesia will be administered, and once a sensory level of T8 is confirmed, the assigned intervention will commence. Intraoperative monitoring will include heart rate, blood pressure, Ramsay Sedation Scale, and communication difficulty using a Likert scale. These will be recorded at specified intervals. At the end of surgery, STAI-6 and VAS-S (Visual Analogue Scale for Satisfaction) will be documented. Headphones will be sanitized after each use.
|