Effect of Virtual Reality Glasses on Pain and Anxiety During Intrauterine Device Insertion in Women

NCT ID: NCT07325695

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2025-07-31

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.

Detailed Description

This randomized controlled study will be conducted among women scheduled for intrauterine device insertion. Eligible participants will be randomly allocated into two groups: a virtual reality intervention group and a control group receiving standard care. Participants in the intervention group will be use virtual reality glasses during the intrauterine device insertion procedure, while the control group will undergo the procedure without virtual reality. Pain intensity will be measured using a validated pain scale during and after the procedure. Anxiety levels will be assessed using a validated state anxiety measurement tool. Sociodemographic and clinical characteristics of participants will also be recorded. The study will be conducted in accordance with ethical principles, and informed consent will be obtained from all participants.

Conditions

Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality Group

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

Group Type: EXPERIMENTAL

Virtual Reality Headset

Intervention Type: DEVICE

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

Control Group

Participants will receive standard care during IUD insertion without VR intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Headset

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Serap Ozturk Altinayak

OTHER

Sponsor Role: lead

Responsible Party

Serap Ozturk Altinayak

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ondokuz Mayis University

Samsun, Samsun, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ondokuz Mayıs Üniversitesi

Identifier Type: -

Identifier Source: org_study_id