| CTRI Number |
CTRI/2025/09/095495 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of virtual reality-based learning on knowledge, attitude, and practice regarding self-care management in patients with type-2 diabetes mellitus. |
|
Scientific Title of Study
|
A study to assess the effectiveness of virtual reality assisted learning on knowledge, attitude and practice regarding self care management of diabetes mellitus among patients with type-2 diabetes mellitus in tertiary care hospital: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raj Kumar Nehara |
| Designation |
M.Sc Nursing Student |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
College of Nursing,All India Institute of Medical Sciences,Kunraghat, Gorakhpur, Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9782422175 |
| Fax |
|
| Email |
rajkumarnehara365@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Renuka K |
| Designation |
Professor cum Principal |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
College of Nursing,All India Institute of Medical Sciences,Kunraghat, Gorakhpur, Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9486537848 |
| Fax |
|
| Email |
drrenukak@aiimsgorakhpur.edu.in |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Renuka K |
| Designation |
Professor cum Principal |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
College of Nursing,All India Institute of Medical Sciences,Kunraghat, Gorakhpur, Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9486537848 |
| Fax |
|
| Email |
drrenukak@aiimsgorakhpur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Kunraghat, Gorakhpur, Uttar Pradesh 273008 |
|
|
Primary Sponsor
|
| Name |
Raj Kumar Nehara |
| Address |
All India Institute of Medical Sciences,Kunraghat, Gorakhpur, Uttar Pradesh 273008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Raj Kumar Nehara |
All India Institute of Medical Sciences,Gorakhpur |
Out patient department(OPD) of All India Institute of Medical Sciences,Kunraghat, Gorakhpur, Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH |
09782422175
rajkumarnehara365@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee,All India Institute of Medical Sciences,Gorakhpur,Uttar Pradesh 273008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine Care as usual |
Routine Care as usual |
| Intervention |
Virtual reality assisted learning regarding self care management of diabetes mellitus among patients with type-2 diabetes mellitus |
A mobile-based virtual reality (VR) video program (Android platform, 360° technique) will be delivered using VR headsets. Participants in the intervention group will receive training on program use, followed by a 15–20 minute VR session. Post-test assessment of knowledge, attitude, and practice regarding self-care management of Type-2 Diabetes Mellitus will be conducted 7 days after the intervention. Total Duration of reseach study is 3 months for data collection.
The VR program includes modules on:
Diabetes mellitus (definition, pathophysiology, risk factors, symptoms, diagnosis, treatment)
Diet (importance, menu, guidelines)
Exercise (importance, techniques)
Self-monitoring of blood glucose (importance, procedure, precautions)
Insulin administration (therapy, sites, procedure, instructions, side effects, hypoglycemia management)
Foot care (daily care, footwear use)
Prevention of complications (diet, exercise, medication adherence, glucose control, foot/eye care, stress management, smoking cessation, routine check-ups) |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Type-2 diabetic individuals who have been diagnosed for at least 6 months, are between 21 and 70 years of age, are on insulin therapy, are willing to participate in the study, and can speak and understand Hindi or English. |
|
| ExclusionCriteria |
| Details |
Type 2 diabetic individuals:-
1. Patients with significant visual or auditory Impairment and critically ill.
2. Pregnant women, including those with gestational Diabetes Mellitus.
3. Patients with severe cognitive impairments.
4. Patients with psychiatric disorders.
5. Patients who are currently or were previously enrolled in a diabetes education program.
|
|
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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 |
To evaluate the effectiveness of Virtual Reality (VR)-Assisted Learning on knowledge, attitude and practice regarding self-care management of patients with Type-2 Diabetes Mellitus (T2DM).
|
Post test after 7 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the knowledge, attitude and practice on self care management among patients with type-2 diabetes mellitus (T2DM) before and after administration of virtual reality assisted learning.
2. To find out the relationship between knowledge, attitude and practice of patients with Type2 Diabetes Mellitus (T2DM) before and after administration of intervention.
3. To associate the knowledge, attitude and practice with selected demographic variables of patients with Type-2 Diabetes Mellitus (T2DM) before and after administration of intervention.
|
Post test after 7 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2025 |
| Date of Study Completion (India) |
19/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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 randomized controlled trial aims to evaluate the effectiveness of Virtual Reality-Assisted Learning on knowledge, attitude, and practice regarding self-care management in patients with Type-2 Diabetes Mellitus. The study will be conducted in the outpatient department of All India Institute of Medical Sciences, Gorakhpur. Eligible participants aged 21–70 years with a minimum 6-month history of Type-2 Diabetes Mellitus will be randomly assigned to intervention and control groups (40 each). The intervention group will receive a mobile-based Virtual Reality program with a 20–30 minute immersive learning 1- session, while the control group will receive routine care. After 7-days of Intervention session the outcomes related to knowledge, attitude, and practice will be assessed pre- and post-intervention using self-structured questionnaires and rating scales. Data will be analyzed using descriptive and inferential statistics, with significance set at p < 0.05. The study aims to generate evidence on the role of Virtual Reality in improving diabetes self-care management. |