NCT07545850

Brief Summary

This randomized controlled experimental study aimed to determine the effect of using virtual glasses during IUD application on pain and anxiety. The hypotheses of the study were determined as follows. H1-a: Using virtual glasses during IUD application affects the level of pain. H1-b: Using virtual glasses during IUD application affects the level of anxiety.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress87%
Mar 2024Aug 2026

Study Start

First participant enrolled

March 31, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

April 22, 2026

Status Verified

April 1, 2025

Enrollment Period

Same day

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

UID Aplicationvirtual realityanxietypainwomen health

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    VAS is a scale created between 0-10 cm. According to the scale, 0 cm: pain is not severe at all, 10 cm: unbearable pain. On the scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain.

    20 minute

Secondary Outcomes (1)

  • Spielberger State Anxiety Inventory

    20 minute

Study Arms (2)

standard care

NO INTERVENTION

The group that did not use virtual reality glasses

group that used virtual reality glasses

EXPERIMENTAL

The group that used virtual reality glasses

Other: virtual reality application

Interventions

Virtual reality (VR) glasses are used as a midwifery intervention to reduce anxiety, stress, comfort and pain by directing the individual's attention to a different direction. VR glasses are a stress induction method that provides a fictional reality simulation with visual-visual orientation and three-dimensional views that allow the person to experience real-time perspective. Although the purpose of designing VR glasses is the entertainment sector and architectural studies, the use of VR glasses in the medical field has been increasing recently. In clinical areas, VR glasses are used to direct the attention of patients to another direction, reduce anxiety, stress and pain, and provide comfort and convenience. Some studies in the field of obstetrics reveal the positive effect of VR glasses.

group that used virtual reality glasses

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Literate,
  • No communication problems,
  • No psychiatric diagnosis,

You may not qualify if:

  • diagnosed with psychiatric disorders having vision problems wearing glasses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Crossover Assignment randomized controlled trial conducted with experimental and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 22, 2026

Study Start

March 31, 2024

Primary Completion

March 31, 2024

Study Completion (Estimated)

August 31, 2026

Last Updated

April 22, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Research results will be shared

Available IPD Datasets

Informed Consent Form (Bilgi Noben 1 2, Simone Maria)Access

Locations