THE EFFECT OF VIRTUAL REALITY APPLICATION ON PAIN, ANXIETY, AND COMFORT DURING CURETTAGE/DILATATION

May 3, 2024 updated by: seda karaçay yıkar, Cukurova University

THE EFFECT OF VIRTUAL REALITY APPLICATION ON PAIN, ANXIETY, AND COMFORT DURING CURETTAGE/DILATATION: A RANDOMIZED CONTROLLED TRIAL

The problems experienced by women at the stage of deciding to have a miscarriage, during and after miscarriage differ and their anxiety levels vary. It was determined that women experienced fear, thinking that they would sin, guilt, regret and indecision at the stage of deciding to abort. methods are used to relieve the pain and anxiety caused by interventional procedures in patients in direct proportion to the development of technology. Virtual reality (VR), one of these methods, is an innovative, up-to-date and unique application, combining reality and imagination with fictional technology.There is no study in the literature on the application of SG during curettage/dilatation procedure. This study was conducted to determine the effect of SG application on pain anxiety and comfort during curettage/dilatation procedure.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

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 Locations

  • Turkey
    • Sarıcam
      • Adana, Sarıcam, Turkey, 00130
        • Seda Karaçay Yıkar

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 15-49 years old,
  • Termination ordered,
  • Can speak and understand Turkish,

Exclusion Criteria:

  • - Cognitive, effective and without any problem preventing communication,
  • No psychiatric problems,
  • Diagnosed with epilepsy (due to the risk that SG glasses may trigger epileptic seizures),
  • Women who volunteer to participate in the study will be recruited.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual reality application
Experimental: virtual reality application virtual reality goggles will be implemented.
Device: virtula reality goggles
no intervention
Other Names:
  • control
Sham Comparator: control
No Intervention: control group no intervention will be made
Device: virtula reality goggles
no intervention
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
virtual reality application
Time Frame: at 1 hour after curettage
virtual reality application reduces women's pain scores 0-5 points
at 1 hour after curettage
virtual reality application
Time Frame: at 1 hour after curettage
virtual reality application reduces women's anxiety scores 20-39 points
at 1 hour after curettage
virtual reality application virtual reality application
Time Frame: at 1 hour after curettage
virtual reality application reduces women's anxiety scores 24-144 points
at 1 hour after curettage

Collaborators and Investigators

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

Sponsor

Cukurova University

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)

May 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 142-16

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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