NCT07325695

Brief Summary

This study aims to evaluate the effect of virtual reality glasses on pain perception and anxiety levels during intrauterine device insertion in women. Participants undergoing intrauterine device insertion will be randomly assigned to either a virtual reality invervention group or a standard care control group. Pain intensity and anxiety levels will be assessed during and after the procedure using validated measurement tools. The findings of this study may contribute to improving patient comfort during intrauterine device insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 9, 2025

Last Update Submit

December 24, 2025

Conditions

Keywords

virtual realityanxietypain management

Outcome Measures

Primary Outcomes (3)

  • Pain insensity during IUD insertion

    Pain severity will be measured immediately after the IUD insertion procedure using the Visual Analog Scale

    İmmediately after the procedure

  • Pain catastrophizing(Pain Catastrophizing Scale, PCS)

    Pain catastrophizing will be assessed immediatel the IUD insertion procedure using the Pain Catastrophizing Scale(PCS;13 items). Higher scores indicate greater catastrophizing.

    İmmediately after the procedure

  • State Anxiety level(STAI-S)

    State anxiety will be measured immediately after the procedure using the State-Trait Anxiety Inventory- State Subscale(STAI-S). Higher scores indicate greater anxiety.

    İmmediately after the procedure

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Participants will wear a VR headset during IUD insertion for pain and anxiety distraction

Device: Virtual Reality Headset

Control Group

NO INTERVENTION

Participants will receive standard care during IUD insertion without VR intervention

Interventions

A VR headset will be used to provide immersive distraction during intrauterine device insertion to reduce pain and anxiety

Virtual Reality Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is based on a female-specific reproductive health intervention(İntrauterine device placement
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those aged 18-49
  • Those who understand and speak Turkish
  • Those without visual or hearing impairments
  • Women who agree to participate in the study
  • Those with adequate mental and emotional health
  • Those who will undergo a copper intrauterine device (IUD)

You may not qualify if:

  • Those outside the 18-49 age range
  • Those who do not speak Turkish
  • Those with visual, hearing, or speech impairments
  • Those with diagnosed psychiatric illnesses
  • Those taking psychiatric medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety DisordersAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two parallel groups wiil be compared: VR distraction during IUD insertion versus standard care control
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 9, 2025

First Posted

January 8, 2026

Study Start

March 4, 2025

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

January 8, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared

Locations