NCT07648134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 9, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Virtual realityIntrauterine device IUD insertionPain managementAnxietyPatient satisfactionQuasi-experimentalNon-pharmacological

Outcome Measures

Primary Outcomes (1)

  • 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.

    During IUD insertion procedure

Secondary Outcomes (1)

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

    Baseline (immediately before IUD insertion) and immediately after the procedure

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants receive virtual reality distraction during intrauterine device insertion.

Behavioral: Virtual Reality

Control Group

NO INTERVENTION

Participants receive routine care during intrauterine device insertion without virtual reality.

Interventions

Virtual RealityBEHAVIORAL

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

Virtual Reality

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, 74322, Egypt

Location

MeSH Terms

Conditions

Anxiety DisordersAgnosiaPatient Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manal Mohammed Ahmed Abdelaziz

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start

September 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 30, 2023

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations