An interventional study of Virtual Reality in Pain During Intrauterine Device Insertion and Anxiety, sponsored by Tanta University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Tanta University · Not applicable, Interventional, and Health services research
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Participants receive virtual reality distraction during intrauterine device insertion.
Behavioral: Virtual Reality
Participants receive routine care during intrauterine device insertion without virtual reality.
Use of virtual reality headset as a distraction method during IUD insertion.
Pain intensity measured using Visual Analog Scale (VAS)
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.
Time frame: During IUD insertion procedure
State anxiety level measured by the State-Trait Anxiety Inventory (STAI) - State subscale (S-Anxiety)
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.
Time frame: Baseline (immediately before IUD insertion) and immediately after the procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Tanta University