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Completed

NCT Number: NCT07648134

Virtual Reality for Pain Reduction During IUD Insertion

This study aims to evaluate the effectiveness of virtual reality (VR) as a non-pharmacological distraction intervention during intrauterine device (IUD) insertion. IUD insertion is commonly associated with pain and anxiety, which may negatively affect patient experience and acceptance of the procedure.

In this quasi-experimental study, women undergoing IUD insertion were allocated into two groups: a virtual reality group receiving immersive audiovisual distraction during the procedure and a control group receiving standard care. Pain intensity and anxiety levels were assessed and compared between the two groups.

The findings of this study are expected to support the use of VR as a safe, simple, and non-invasive method to reduce procedural pain and anxiety and improve patient satisfaction during IUD insertion.

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Key information

Conditions

Pain During Intrauterine Device Insertion Agnosia Anxiety Anxiety Disorders Behavior Health Behavior Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospital

Tanta, 74322, Egypt

About this study

This quasi-experimental pretest-posttest study with a non-equivalent control group was conducted to evaluate the effectiveness of virtual reality (VR) as a non-pharmacological distraction intervention during intrauterine device (IUD) insertion.

A total of 90 women undergoing IUD insertion were enrolled and allocated into two groups using clinic registration numbers: an intervention group (VR group) and a control group. The control group received standard care, including routine pre-procedural counseling and IUD insertion, while the intervention group received the same standard care in addition to a virtual reality-based intervention.

The VR intervention consisted of both pre-procedural and intra-procedural components. Before the procedure, participants viewed a structured educational video explaining the IUD insertion process. During the procedure, participants wore a head-mounted virtual reality device displaying immersive calming audiovisual content, such as natural landscapes accompanied by soft music, to provide distraction and reduce attention to procedural stimuli.

The primary outcome was pain intensity, assessed during IUD insertion using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Secondary outcomes included state anxiety, measured using the State-Trait Anxiety Inventory (STAI) State subscale (score range: 20-80, with higher scores indicating greater anxiety), and patient satisfaction with the procedure.

Outcome measures were assessed at baseline (immediately before the procedure) and immediately after IUD insertion. The study was conducted in a clinical setting at Tanta University, and ethical approval was obtained prior to data collection.

This study aims to provide evidence regarding the effectiveness of VR as a safe, non-invasive, and cost-effective intervention to reduce pain and anxiety and improve the overall patient experience during IUD insertion procedures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women eligible for intrauterine device (IUD) insertion
  • Age between 18 and 45 years
  • Willing to participate and provide informed consent

Exclusion criteria

  • Contraindications to IUD insertion
  • History of severe anxiety disorders
  • Previous adverse reaction to virtual reality
  • Refusal to participate

Treatment and study plan

Virtual reality

Behavioral

Use of virtual reality headset as a distraction method during IUD insertion.

Primary outcomes

  1. Pain intensity measured using Visual Analog Scale (VAS)

    Time frame: During IUD insertion procedure

    Pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.

Secondary outcomes

  1. State anxiety level measured by the State-Trait Anxiety Inventory (STAI) - State subscale (S-Anxiety)

    Time frame: Baseline (immediately before IUD insertion) and immediately after the procedure

    State anxiety will be assessed using the STAI State subscale (S-Anxiety), a validated 20-item self-report tool. Items are rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate greater levels of state anxiety.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Virtual Reality as a Non-Pharmacological Distraction Intervention During Intrauterine Device Insertion: A Quasi-Experimental Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2026
Registry last updated
Jun 15, 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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