FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/071148 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Virtual Reality as a tool for counselling about office hysteroscopy can reduce anxiety 
Scientific Title of Study   Preoperative virtual reality video to reduce anxiety in women undergoing office hysteroscopy 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanvir  
Designation  Consultant, MS OBGYN 
Affiliation  Tanvir Hospital  
Address  Tanvir Hospital, Department of Obstetrics and Gynaecology, Minimally Invasive Surgery Division, First floor. 8-3-833/100, phase.1, kamalapuri colony, Hyderabad

Hyderabad
TELANGANA
500073
India 
Phone  919924766379  
Fax    
Email  tanvirsinghtan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tanvir  
Designation  Consultant, MS OBGYN 
Affiliation  Tanvir Hospital  
Address  Tanvir Hospital, Department of Obstetrics and Gynaecology, Minimally Invasive Surgery Division, First floor. 8-3-833/100, phase.1, kamalapuri colony, Hyderabad

Hyderabad
TELANGANA
500073
India 
Phone  919924766379  
Fax    
Email  tanvirsinghtan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tanvir  
Designation  Consultant, MS OBGYN 
Affiliation  Tanvir Hospital  
Address  Tanvir Hospital, Department of Obstetrics and Gynaecology, Minimally Invasive Surgery Division, First floor. 8-3-833/100, phase.1, kamalapuri colony, Hyderabad

Hyderabad
TELANGANA
500073
India 
Phone  919924766379  
Fax    
Email  tanvirsinghtan@gmail.com  
 
Source of Monetary or Material Support  
Tanvir Hospital  
 
Primary Sponsor  
Name  Tanvir 
Address  8-3-833/100, phase.1, kamalapuri colony,Hyderabad Hyderabad TELANGANA 500073 India  
Type of Sponsor  Other [Self] 
 
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 Tanvir   Tanvir Hospital   8-3-833/100, phase.1, kamalapuri colony, Hyderabad
Hyderabad
TELANGANA 		 9924766379

tanvirsinghtan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tanvir Hospital - Institutional Ethics Committee for Biomedical & Health Research  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  No Virtual reality  For the comparator group after primary counselling about the need for office hysteroscopy by the gynaecologist, their visual analogue score of anxiety is noted. These women are not exposed to the virtual reality video preoperatively. 
Intervention  Virtual reality   The virtual reality (VR) video is made with the help of the UNITY 3D software platform using C# computer language. The gynaecologist provides primary counselling regarding the need for office hysteroscopy to the woman. The VR video consists of a 4-minute video explaining the procedure of office hysteroscopy in general and not specific to any pathology, and care to be taken before and after hysteroscopy is shown to the woman. They are made to experience office hysteroscopy through VR video preoperatively. After experiencing VR the patients doubts will be clarified by the care provider and a visual analogue score of anxiety (VAS - A) will be noted.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Women above 18 years of age planned for OH. Those who are able to provide informed consent. 
 
ExclusionCriteria 
Details  Those who have hearing problems. Those who cannot give consent. Those who decline participation. Women who have undergone previous office hysteroscopy by vaginoscopy technique. Women with a prior history of psychological disease.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measured is the comparison of preoperative anxiety scores as assessed by
VAS - A, in both interventional and control groups. 		 At baseline  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the postoperative pain scores, success rate & Likert scale of satisfaction in the interventional group & the control group.  At baseline  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   05/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="10" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [tanvirsinghtan@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 01-12-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Hysteroscopy is the gold standard for diagnosis and treatment of intrauterine pathologies. Traditionally, it is performed under anaesthesia. Today, because of the miniaturization of the instru ments, hysteroscopy, both diagnostic and operative is feasible without anaesthesia in the physician’s office, where it’s possible that the patient can walk in and walk out in less than an hour. The challenge is anxiety faced by women prior to office hysteroscopy (OH) in anticipation of pain. Virtual reality (VR) is a non - pharmacological intervention to reduce pre- operative anxiety, by sensitising patients of the planned surgery and the operating room. This helps in reducing their fear. The VR consists of a video of 4 minutes duration explaining the procedure of OH in general and not specific to any pathology, and care to be taken before and after hysteroscopy.The VR is made with the help of  a UNITY 3D software platform using C# computer language. After experiencing VR, doubts will be clarified by the health care provider and a visual analogue score of anxiety (VAS - A) is noted.  We aim to do an open labelled randomised controlled trial and compare the anxiety rates between both groups of women undergoing office hysteroscopy.

 
Close