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Completed

NCT Number: NCT07325695

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

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.

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Key information

Conditions

Pain Agnosia Anxiety Anxiety Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Headset

Device

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

Primary outcomes

  1. Pain insensity during IUD insertion

    Time frame: İmmediately after the procedure

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

  2. Pain catastrophizing(Pain Catastrophizing Scale, PCS)

    Time frame: İmmediately after the procedure

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

  3. State Anxiety level(STAI-S)

    Time frame: İmmediately after the procedure

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

Sponsors and collaborators

Lead sponsor

Serap Ozturk Altinayak

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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