Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures (VR)

August 2, 2023 updated by: Assuta Ashdod Hospital

Using Virtual Reality (VR) Technology in Gynecological Procedures

A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will.

After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology.

Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
  • amniocintesis -single tone,gestional age 16-24 week,
  • hysteroscopy-women age 18-60 , diagnostic procedure,

Exclusion Criteria:

  • ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
  • amniocintesis- Known fetal malformations, amnionitis
  • hysteroscopy-pregnancy, PID

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
patients undergoing one of the procedures without using VR device
Active Comparator: VR without sound
patients undergoing one of the procedures using VR device without sound
Device: VR without positive psychology
Using VR goggles showing relaxing short videos without sound
Active Comparator: VR with sound
patients undergoing one of the procedures using VR device with sound
Device: VR with positive psychology
Using VR goggles showing relaxing short videos with positive psychological messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress cortisol saliva level
Time Frame: up to 5 minutes after the procedure
each arm after the procedure will be mesured stress cortisol level in saliva
up to 5 minutes after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain levels
Time Frame: up to 5 minutes after
each arm after the procedure will fill pain questioner. pain questioners using visual analog score. 0- to 10, while 0 is no pain at all, 10 is the worse pain ever felt.the patients will fill the questioner before and after the procedures.
up to 5 minutes after
anxiety levels
Time Frame: up to 5 minutes after
each arm after the procedure will fill anxiety questioner. anxiety questioner using the short depression , anxiety and stress scale (DASS-21). the patients will fill the questioners before and after the procedures.
up to 5 minutes after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assuta Ashdod Hospital

Investigators

  • Principal Investigator: Noa glick fishman, MD, Assuta Ashdod

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

July 10, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 0125-22-AAA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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