- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07648134
Virtual Reality for Pain Reduction During IUD Insertion
Virtual Reality as a Non-Pharmacological Distraction Intervention During Intrauterine Device Insertion: A Quasi-Experimental Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt, 74322
- Tanta university hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality
Participants receive virtual reality distraction during intrauterine device insertion.
|
Use of virtual reality headset as a distraction method during IUD insertion.
|
|
No Intervention: Control Group
Participants receive routine care during intrauterine device insertion without virtual reality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During IUD insertion procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (immediately before IUD insertion) and immediately after the procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VR-IUD-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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