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

The Effect of Virtual Reality Glasses on Perceived Pain and State Anxiety Levels During Intrauterine Device Insertion: a Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Device: Virtual Reality Headset

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Samsun
    • Samsun, Samsun, Turkey (Türkiye)
      • Ondokuz Mayis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Group; Participants will wear a VR headset during IUD insertion for pain and anxiety distraction	Device: Virtual Reality Headset; A VR headset will be used to provide immersive distraction during intrauterine device insertion to reduce pain and anxiety
No Intervention: Control Group; Participants will receive standard care during IUD insertion without VR intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Serap Ozturk Altinayak

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; virtual reality; pain management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Agnosia
• Other Study ID Numbers: Ondokuz Mayıs Üniversitesi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No