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Enrolling by invitation NCT07545850

Determination of the Effect of Using Virtual Glasses on Pain and Anxiety During IUD Application

No phase Interventional Women Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtual reality application.
Who it may be relevant to
Registry conditions: Women Health. Basic parameters: 18 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

Data collection tools will be collected from women who applied IUD between March 2024-March 2025 at the Family Planning Clinic of Malatya Education and Research Hospital and who agreed to participate in the study, using the face-to-face interview method on weekdays by the researchers. Data will be collected in two stages. The application time of the data collection tools is planned to be completed in approximately 20 minutes as pre-test and post-test. Before the SG glasses are applied to the women in the experimental group, the Personal Information Form, State Anxiety Scale (SAS), and Visual Analog Scale (VAS) will be applied and pre-test data will be collected. Then, these women will watch videos with nature scenery while using SG glasses. After the IUD application process is completed, the State Anxiety Scale (SAS), Visual Analog Scale (VAS) and a survey containing questions about SG glasses will be applied to the women in the experimental group again and the post-test data will be collected and the data collection process will be completed. Pre-test data will be collected by applying the State Anxiety Scale (SAS) and Visual Analog Scale (VAS) to the women in the control group before the IUD application. No intervention will be applied to these women during the IUD application process. After the IUD application process is completed, the State Anxiety Scale (SAS) and Visual Analog Scale (VAS) will be applied to the women in the control group again, and the post-test data will be collected, and the data collection process will be completed.

Interventions

  • Other virtual reality application
    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 glasse

Primary outcome measures

  • Visual Analog Scale (VAS) [Time frame: 20 minute]
Secondary outcome measures (1)
  • Spielberger State Anxiety Inventory [Time frame: 20 minute]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

diagnosed with psychiatric disorders having vision problems wearing glasses

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Inonu University — Malatya

Identifiers

NCT: NCT07545850 · 2023/5362

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗