| CTRI Number |
CTRI/2025/12/098497 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Operation Room Noise on Patient Stress and Comfort |
|
Scientific Title of Study
|
Impact of Intraoperative Noise and Patient Sensitivity on Stress and Satisfaction During Regional Anesthesia: A Prospective Observational 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 |
Jasmine Abika |
| Designation |
Pg Scholar |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No:D4-23,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU
603203
India |
| Phone |
6379601423 |
| Fax |
|
| Email |
jasmineabikafotat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthika Urkavalan |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science And Technology |
| Address |
Room No:D4-27,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU
603203
India |
| Phone |
9894234694 |
| Fax |
|
| Email |
Karthiku1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthika Urkavalan |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science And Technology |
| Address |
Room No:D4-27,4th floor, D block Extension, Department of Anesthesia, SRM medical college, SRM Nagar,Potheri, Kattankulathur, Chengalpattu district, Tamil Nadu -603203 India.
Chennai
TAMIL NADU
603203
India |
| Phone |
9894234694 |
| Fax |
|
| Email |
Karthiku1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science And Technology |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science And Technology |
| Address |
SRM medical college Hospital and Research Centre,
SRM Nagar Potheri, Kattankulathur Chengalpattu Tamil Nadu -603203
India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 karthika Urkavalan |
SRM Medical College Hospital |
Room No:D4 23,4th floor,
D block Extension,
Department of Anesthesia SRM medical college,
SRM Nagar Potheri, Kattankulathur,
Chengalpattu district,
Tamil Nadu 603203 India
Chennai
TAMIL NADU |
9894234694
Karthiku1@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M151||Heberdens nodes (with arthropathy), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified Weinstein Noise Sensitivity Questionnaire
|
A validated questionnaire used to measure each patient’s general sensitivity to everyday sounds. It helps identify whether a patient is more likely to be disturbed by noise before surgery.
|
| Intervention |
NIL |
NIL |
| Comparator Agent |
Noise Satisfaction and Annoyance Questionnaire |
A postoperative questionnaire that evaluates the patient’s satisfaction with the noise level during surgery and assesses how annoyed or disturbed they felt by the sounds in the operating room. |
| Comparator Agent |
Noise-Related Stress Questionnaire |
A brief questionnaire completed after surgery to measure the amount of stress the patient experienced due to intraoperative noise. It helps quantify the emotional impact of the operating room sound environment. |
| Comparator Agent |
smartphone - decibel x meter app |
A calibrated smartphone sound-level meter application used to measure intraoperative noise. It records minimum, maximum, and average noise levels (in decibels) at regular time intervals during surgery. |
| Comparator Agent |
State-Trait Anxiety Inventory – State Short Form (STAI-6) |
A short 6-item scale used to assess the patient’s immediate anxiety level after surgery. It measures how anxious the patient felt during and right after the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 65 years
2.Elective orthopedic surgeries under regional anesthesia
3.ASA I to II
4.Conscious and communicative during procedure
5.Provides informed written consent
6.Willing to complete pre operative and post operative questionnaires
|
|
| ExclusionCriteria |
| Details |
1.Surgery under general anesthesia or sedation
2.Hearing impairment or hearing aid use
3.Psychiatric illness affecting stress perception
4.Anxiolytic or sedative use within 24 hours
5.Cognitive or communication impairment
6.Emergency or revision surgeries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study is expected to show a significant link between higher noise levels during surgery and increased stress in awake patients. Additionally, patients who are more sensitive to noise may report lower satisfaction with their surgical experience. These findings could support efforts to improve the acoustic environment in operating rooms, enhancing patient comfort during regional anesthesia.
|
Patients noise sensitivity will be checked before surgery. Noise levels will be noted during surgery every 30 minutes. After surgery, patients will be asked a few simple questions about their stress, anxiety, and satisfaction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
15/12/2025 |
| 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="8"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- 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 - Proposals should be directed to [jasmineabikafotat@gmail.com].
- For how long will this data be available start date provided 01-10-2026 and end date provided 01-10-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This prospective observational study evaluates how intraoperative noise and individual noise sensitivity affect stress and satisfaction in orthopedic patients undergoing regional anesthesia. Baseline demographics, vitals, and noise sensitivity are recorded preoperatively using the Modified Weinstein Questionnaire. During surgery, the noise in the operating room will be measured using a smartphone sound meter. The app will check how loud the sound is at different times and record the lowest, highest, and average noise levels every 30 minutes. Immediately after surgery, patients is assessed for anxiety using the STAI (State- Trait Axiety Inventory)-6 and Noise Satisfaction and Annoyance Questionnaire . Postoperatively, patients complete a Noise-Related Stress Questionnaire and a Visual Analog Scale. All data are collected in a standardized case report form. The study aims to identify associations between noise sensitivity, actual noise exposure, intraoperative stress, and overall patient satisfaction. |