NCT06403579

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1 month

First QC Date

May 3, 2024

Last Update Submit

May 3, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

virtual reality application

EXPERIMENTAL

Experimental: virtual reality application virtual reality goggles will be implemented.

Device: virtula reality goggles

control

SHAM COMPARATOR

No Intervention: control group no intervention will be made

Device: virtula reality goggles

Interventions

no intervention

Also known as: control
controlvirtual reality application

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women will be included
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old,
  • Termination ordered,
  • Can speak and understand Turkish,

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seda Karaçay Yıkar

Adana, Sarıcam, 00130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 8, 2024

Study Start

May 1, 2024

Primary Completion

June 1, 2024

Study Completion

May 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations