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Virtual Reality for Pain Reduction During IUD Insertion

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07648134
Enrollment
90
Registered
2026-06-15
Start date
2022-09-01
Completion date
2023-03-30
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain During Intrauterine Device Insertion

Keywords

Virtual reality, Intrauterine device IUD insertion, Pain management, Anxiety, Patient satisfaction, Quasi-experimental, Non-pharmacological

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALVirtual Reality

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity measured using Visual Analog Scale (VAS)During IUD insertion procedurePain 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

MeasureTime frameDescription
State anxiety level measured by the State-Trait Anxiety Inventory (STAI) - State subscale (S-Anxiety)Baseline (immediately before IUD insertion) and immediately after the procedureState 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026