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Enrolling by Invitation

NCT Number: NCT07545850

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

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.

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Key information

Conditions

Women Health Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

diagnosed with psychiatric disorders having vision problems wearing glasses

Treatment and study plan

Virtual Reality Application

Other

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 20 minute

    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.

Secondary outcomes

  1. Spielberger State Anxiety Inventory

    Time frame: 20 minute

    The State Anxiety Inventory (SAI) requires the individual to describe how he/she feels at a certain moment and under certain conditions. The inventory is answered using 4-point scales. The feelings and behaviors expressed in the SAI items are indicated by selecting one of the following options: "(1) Not at all, (2) A little, (3) A lot, and (4) Completely" according to the severity of such experiences. There are 10 reverse items in the SAI. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The remaining items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18 directly measure the expression. Two separate keys are prepared to determine the total weights of the direct and reverse items in scoring. The total weighted score of the reverse items is subtracted from the total weighted score obtained for direct expressions. A previously determined unchanging value is added to this obtained number. This value is 50 for the State Anxiety Inventory. A high score obtained from the scale indicates a high

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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