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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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