Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

May 30, 2022 updated by: Tel-Aviv Sourasky Medical Center
To evaluate the effectiveness of virtual reality glasses as a distraction technique in the management of acute pain and anxiety during conization of cervix uterus under local anesthesia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective, open-label, randomized control trial in a tertiary university affiliated medical center between March 2021 to March 2023. Overall, 100 women referred for conization of cervix due to cervical dysplasia will be randomly allocated to undergo conization either with the use of virtual reality glasses (study group) or with standard treatment (control group). The primary outcome measures will include self-reported pain, anxiety scores, and vital signs as an indirect measurement of pain and anxiety, including pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes will be measured as numeric rating scores.

Study Type

Interventional

Enrollment (Anticipated)

100

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

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
        • Principal Investigator:
          • eli shprecher, prof.
        • 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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Patients over 18 years referred for conization of cervix due to cervical dysplasia

Exclusion Criteria:

  • patients under 18 years
  • pregnant women

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality glasses
Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure with Virtual reality glasses on
Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted display
For the study group, virtual reality content will be shown to the participant for the duration of the conization procedure through a head-mounted display, RelieVRTM. The default VR content for the trial will be "swimming with dolphins" or any other content chosen by the participant
No Intervention: No intervention. standard treatment
Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure without virtual reality glasses (no intervention)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessments of pain through pain score parameter
Time Frame: 20 minutes
Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain in which 0 is no pain and 10 is the worst imaginable pain
20 minutes
Assessments of pain through physiological parameters
Time Frame: 20 minutes
Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using heart rate beats per minute
20 minutes

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

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 (Actual)

May 19, 2022

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0097-21-TLV

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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Clinical Trials on SootheVR: AppliedVR, Los Angeles, California a head-mounted display

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