| CTRI Number |
CTRI/2025/03/083359 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
using sound of nature or virtual reality videos of natural scenery for decreasing anxiety before surgery |
|
Scientific Title of Study
|
Comparison of unimodal, non-pharmacological, preoperative psychological prehabilitation intervention: Nature Soundscape Immersion and Virtual reality on preoperative anxiety and stress reduction- A randomised non inferiority trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prakash Gyandev Gondode |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 5011, Department of Anaesthesiology , pain Medicine and Critical care, Teaching Block, main building, AIIMS, New Delhi, Ansari Nagar
Room no 5011, Department of Anaesthesiology , pain Medicine and Critical care, Teaching Block, main building, AIIMS, New Delhi, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
8826434672 |
| Fax |
|
| Email |
drprakash777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prakash Gyandev Gondode |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 5011, Department of Anaesthesiology , pain Medicine and Critical care, Teaching Block, main building, AIIMS, New Delhi, Ansari Nagar
Room no 5011, Department of Anaesthesiology , pain Medicine and Critical care, Teaching Block, main building, AIIMS, New Delhi, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
8826434672 |
| Fax |
|
| Email |
drprakash777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prakash Gyandev Gondode |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 5011, Department of Anaesthesiology , pain Medicine and Critical care, Teaching Block, main building, AIIMS, New Delhi, Ansari Nagar
Room no 5011, Department of Anaesthesiology , pain Medicine and Critical care, Teaching Block, main building, AIIMS, New Delhi, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
08826434672 |
| Fax |
|
| Email |
drprakash777@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS New Delhi, Ansari nagar, New Delhi 110003 |
| 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 Prakash Gondode |
All India Institute of Medical Sciences, New Delhi |
Main Operation theatre, Floor no AB8,Room no (OT 1 to OT 12) Department of Anesthesiology, Pain Medicine and Critical care. Main building.
Central
DELHI |
8826434672
prakashgondode@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute_Ethics_Committee_AIIMS_New_Delhi |
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: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nature soundscape intervention |
The NSI intervention will be explained to the group B, following they will receive a Nature soundscape immersion experience for 10 minutes. The NSI audio will be having calming recordings of natural sounds, such as flowing water, birdsong, and rustling leaves. The patients will be asked to adopt the position they were most comfortable with, and the Noice cancelling blue tooth headset will be placed on the patients’ head. [Sony Noice cancelling Bluetooth headset device] After the end of the session, the headset will be removed. |
| Comparator Agent |
Virtual reality |
The VR procedure will be explained to the group A, following they will receive a virtual reality visual experience for 10 minutes. The VR video will be a 360-degree video with calming nature video. The patients will be asked to adopt the position they were most comfortable with, and the VR device will be placed on the patients’ faces at the most appropriate angle. [Jio dive VR headset equipped with a IQOO z7 Pro smartphone.] After the video ended, the VR headset will be removed from the patients’ faces. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
Adults aged 18 to 70 years.
Patients scheduled for first elective surgery under general anesthesia.
Ability to understand and complete APAIS and VAS scales.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Patients with visual impairments (for VR group).
Hearing impairments (for music group).
Known psychiatric conditions affecting anxiety.
Previous experience with VR or music therapy within 3 months before surgery.
Patients on preoperative anxiolytics or sedative medications. |
|
|
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 |
Preoperative Anxiety: Measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Scores range from 6–30, with higher scores indicating
higher anxiety levels. This will be assessed immediately before the intervention and
immediately after the intervention. |
T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceived Stress: Assessed using a 10-point Visual Analogue Scale (VAS), where 0 indicates no stress and 10 indicates extreme stress. This will be assessed before and after the intervention. |
T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room. |
| Patient Satisfaction: Measured using a 10-point VAS to evaluate satisfaction with the anxiety-reducing intervention. This will be assessed postoperatively. |
T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room. |
| Patient Vitas: Heart rate and Blood pressure using the standard monitors. |
T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room. |
| Simulation Sickness score. |
T0- Pre intervention, T1 Post-intervention, T2- Preoperative room, T3- Postoperative Recovery room. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
10/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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 - NO
|
|
Brief Summary
|
Summary of the Study Title: Comparison of unimodal, non-pharmacological, preoperative psychological prehabilitation intervention: Nature Soundscape Immersion (NSI) vs. Virtual Reality (VR) on preoperative anxiety and stress reduction – A randomized non-inferiority trial. Background:
Preoperative anxiety affects 11–80% of surgical patients, leading to adverse physiological and psychological outcomes. While pharmacological treatments exist, they have limitations like side effects and prolonged hospital stays. Non-pharmacological interventions, such as psychological prehabilitation, have shown promise in reducing anxiety and improving surgical outcomes. VR and NSI are two such methods, with VR offering immersive experiences and NSI providing cost-effective, low-risk nature sound immersion. Objective:
To evaluate whether NSI is non-inferior to VR in reducing preoperative anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Secondary outcomes include stress, patient satisfaction, physiological parameters, and simulation sickness scores. Study Design: - Type: Randomized, non-inferiority trial.
- Setting: Preoperative areas, AIIMS New Delhi.
- Duration: 6 months.
- Participants: 120 adults (18–70 years) undergoing elective surgery under general anesthesia.
Intervention: - Group A (VR): 10 minutes of calming VR visual experience.
- Group B (NSI): 10 minutes of nature sound immersion via noise-cancelling headphones.
Outcome Measures: - Primary: Anxiety reduction (APAIS scores).
- Secondary: Stress (VAS scores), patient satisfaction, physiological parameters (BP, HR), and simulation sickness scores.
Key Features: - Randomized allocation to groups using a 1:1 ratio.
- Blinded outcome assessment.
- Statistical analysis includes non-inferiority testing and descriptive statistics.
Ethics and Data Management:
The study adheres to ethical guidelines, with written informed consent obtained from participants. Data will be anonymized and securely stored. This trial aims to provide evidence for NSI as a practical, accessible alternative to VR for managing preoperative anxiety and stress. |