| CTRI Number |
CTRI/2025/04/085887 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Effect of virtual reality distraction] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Virtual reality for reducing pain and anxiety during dialysis needle insertion |
|
Scientific Title of Study
|
A randomized crossover trial to assess the effectiveness of virtual reality on pain and anxiety during vascular cannulation among patients undergoing maintenance hemodialysis at AIIMS, New Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit mann |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
College of Nursing, All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
9311097010 |
| Fax |
|
| Email |
mannamit811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manju Rajora |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
College of Nursing, All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
manjuakrajora@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Rajora |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
College of Nursing, All India Institute of Medical Sciences New Delhi
South
DELHI
110029
India |
| Phone |
9870260036 |
| Fax |
|
| Email |
manjuakrajora@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Indian society of Nephrology North zone, Department of Nephrology & Renal Transplant Medanta – The Medicity,
Choudhary Baktawar Singh Road,
Sector 38 Gurugram, 122001 |
|
|
Primary Sponsor
|
| Name |
Amit Mann |
| Address |
College of Nursing, Sri Aurobindo marg, Ansari nagar, All India Institute of Medical Sciences, New Delhi, India, PIN - 110029 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Amit Mann |
All India Institute of Medical Sciences |
Dialysis Unit, Fourth floor, Main Hospital All India Institute of Medical Sciences New Delhi
South
DELHI |
9311097010
mannamit811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
Routine care involves hand hygiene, the use of personal protective equipment, disinfecting the puncture site, inserting the needle, securing the needle, and observing the procedure as it progressed. |
| Intervention |
Virtual reality |
Hardware - The Oculus Quest 2 headset which has built-in audio will be used in the study.
Software – "ReMind" is a software developed by Sparsh Mind Innovations Pvt. Ltd. that will be used to display 3 dimensional (3D) videos to participants through headsets.
3D videos of natural landscapes like hills, tropical beaches, deserts, underwater scenes, and green forests, with calming nature sounds will be played through the VR headset.
The duration of the intervention will be 5 minutes, with 2 minutes of video shown before the arteriovenous fistula puncture for vascular cannulation, and the remaining 3 minutes during the vascular cannulation procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients aged between 18 and 75 years.
b) Patients undergoing maintenance hemodialysis 3 times in a week.
c) Patients scheduled for AV fistula cannulation for hemodialysis.
d) Patients who are willing to participate in the study and provide informed consent..
e) Patients have an orientation to time, person, and place.
f) Patient having sufficient vision and hearing capabilities (ability to see images with or without glasses and hear sounds from a distance of at least half a meter).
|
|
| ExclusionCriteria |
| Details |
a) Patient had seizure episodes within the last 6 months.
b) Patient having difficulty in speaking.
c) Claustrophobia
d) Patients with a known history of cybersickness.
e) Patient received analgesic within 6 hours before of vascular cannulation.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
1. Expected pain during vascular cannulation will be assessed before intervention.
2. Pain experienced during vascular cannulation will be assessed immediately once procedure is completed and virtual headset device is removed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anxiety |
1. Pre procedural anxiety before intervention
2. Procedural anxiety experienced during vascular cannulation after removal of headset device. |
| Physiological parameters which includes various components i.e. heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), respiration rate (RR), saturation of peripheral oxygen(spo2). |
1. Before intervention
2. During vascular cannulation
3. After vascular cannulation and removal of virtual reality headset device |
| Patient satisfaction with virtual reality |
1. 10 minutes after vascular cannulation |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2025 |
| Date of Study Completion (India) |
31/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - NO
|
|
Brief Summary
|
This study aims to evaluate the effectiveness of virtual reality as a non-pharmacological intervention to reduce pain and anxiety during vascular cannulation in hemodialysis patients. This study will use a Quantitative, Randomized crossover trial design among patients undergoing arteriovenous fistula cannulation for maintenance hemodialysis in the dialysis unit at All India Institute of Medical Sciences, New Delhi. Intervention: Group 1: VR intervention using the Oculus Quest 2 headset with calming, nature-themed 3D videos during vascular cannulation. Group 2: Standard care involving routine cannulation procedures. Groups will switch interventions after a two-week washout period. Outcomes: Pain (Numeric Pain Rating Scale), anxiety (Visual Analogue Scale for Anxiety), physiological parameters (e.g., HR, BP, RR, SpO2), and patient satisfaction. Collected data will be analysed through descriptive and inferential statistics.
|