| CTRI Number |
CTRI/2024/09/073756 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of smartphone based virtual reality in reducing anxiety during dermatosurgical procedures |
|
Scientific Title of Study
|
Efficacy of smartphone based virtual reality for the alleviation of anxiety during dermatosurgical procedures: A Mixed method stratified randomized controlled 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 |
Dr Karthik L |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry |
| Address |
Department of Dermatology,
Jawaharlal Institute of Postgraduate
Medical Education and Research (JIPMER), Dhanvanthri Nagar, Gorimedu,
Pondicherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9944674451 |
| Fax |
4132296000 |
| Email |
jr8329@jipmer.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Laxmisha Chandrashekar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry |
| Address |
Department of Dermatology, Jawaharlal Institute of Postgraduate
Medical Education and Research (JIPMER), Dhanvanthri Nagar, Gorimedu,
Pondicherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9894119058 |
| Fax |
4132296000 |
| Email |
laxmishac@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Laxmisha Chandrashekar |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry |
| Address |
Department of Dermatology, Jawaharlal Institute of Postgraduate
Medical Education and Research (JIPMER), Dhanvanthri Nagar, Gorimedu,
Pondicherry
PONDICHERRY 605006 India |
| Phone |
9894119058 |
| Fax |
4132296000 |
| Email |
laxmishac@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, India.
Pincode: 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
JIPMER Dhanvantri Nagar Gorimedu Pondicherry -605006 |
| 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 Karthik L |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
OPD No -85 Room No:9
Department of Dermatology
JIPMER Pondicherry PONDICHERRY |
9944674451
jr8329@jipmer.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OFFICE OF THE DEAN (RESEARCH) - INSTITUTIONAL ETHICS COMMITTEE FOR INTERVENTIONAL STUDIES - CDSCO Reg. No: ECR/342/Inst/PY/2013/RR-19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator |
Patients who will undergo dermatological procedures without Virtual Reality. |
| Intervention |
Virtual Reality |
Patients who will undergo dermatological procedures with
Virtual Reality |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age ≥18 years
2)Those being planned for cryosurgery, biopsy, electro and radiosurgery and intralesional therapy |
|
| ExclusionCriteria |
| Details |
1) Patients who are coming for follow up visits for dermatological procedures
2) Patients having impairment of vision
3) Patients having impairment of hearing.
4) Patients in whom the virtual reality headset will cause obstruction in the dermatological procedure owing to the location of the lesion.
5) Patients not comfortable wearing the virtual reality headset or undergoing virtual reality intervention.
6) Seizures |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the end point anxiety scores in patients receiving virtual reality during dermatological procedures versus control patients who did not receive virtual reality as measured by VAS (A). |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess & compare the end point anxiety scores in patients receiving virtual reality during dermatological procedures versus control patients who did not receive virtual reality as measured by short version of STAI. |
Baseline |
| To assess & compare the end point pain scores (VAS(P)), galvanic skin response & heart rate measurements & satisfaction scores in patients receiving virtual reality during dermatological procedures versus control patients who did not receive virtual reality. |
Baseline |
| To explore the perspectives of patients & providers on use of VR as an adjunct to dermatosurgical procedures |
Baseline |
| To assess the physician satisfaction as measured using a Likert scale in the two groups |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="232" Sample Size from India="232"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="232" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| Date of Study Completion (India) |
03/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="11" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Anxiety and pain are the commonest symptoms in clinical practice and effective management of these is crucial to optimise medical procedures, boost patients’ satisfaction, reduce hospital stay and minimise long-term analgesic dependence. Hence, some sort of distraction and relaxation techniques becomes necessary to keep the patient at ease during the procedure. Various modalities have been tried including music 1, watching videos 1, virtual reality (VR) 2, stress balls 3, etc., The use of virtual reality (VR) technology has emerged as a potential tool to distract patients and to modify their perception of pain 2. Previous studies have shown that distraction is the most common technique used to reduce pain in short invasive medical procedures 4. Techniques like watching video via VR prevents patients from seeing what is happening in the real world and directs the focus on what is going on in the virtual world and it works by utilizing some part of human’s cognitive capacity leaving less of it available for processing pain 2. Its adoption in clinical practice especially in dermatology remains limited. Dermatology practice also includes several minor procedures for skin lesions, including skin cancers, most of which are done performed under topical or injectable local anaesthesia. Pain and anxiety during the procedure is a significant concern since the patient is alert and awake intraoperatively and can be challenging for both clinicians and patients 3. Several previous studies have assessed the role of VR in the management of pain and anxiety in medical and surgical procedures. However, studies the efficacy of VR on pain and anxiety during dermatological procedures is scarce. Hence, we propose to study the efficacy of VR on pain and anxiety during dermatological procedures which has not been evaluated so far to the best of our knowledge. This study will assess the efficacy of virtual reality as a clinical tool in the alleviation of pain and anxiety during dermatological procedures. |