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

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: Bleeding;Post D&C; PAIN, ANXIETY, AND COMFORT
• Intervention / Treatment: Device: virtula reality goggles

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	virtual reality application reduces women's pain scores 0-5 points	at 1 hour after curettage
virtual reality application	virtual reality application reduces women's anxiety scores 20-39 points	at 1 hour after curettage
virtual reality application virtual reality application	virtual reality application reduces women's anxiety scores 24-144 points	at 1 hour after curettage

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

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: Mental Disorders; Anxiety Disorders
• 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