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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Women Health
• Intervention / Treatment: Other: virtual reality application

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.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Malatya, Turkey (Türkiye)
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

diagnosed with psychiatric disorders having vision problems wearing glasses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care; The group that did not use virtual reality glasses
Experimental: group that used virtual reality glasses; The group that used virtual reality glasses	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spielberger State Anxiety Inventory	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	20 minute

Collaborators and Investigators

• Sponsor: Inonu University

Publications and helpful links

Helpful Links

• Noben L, Goossens SMTA, Truijens SEM, Van BMMG, Perquin CW, Slooter GD, Van RSJ. A virtual reality video to improve information provision and reduce anxiety before cesarean delivery: randomized controlled trial. JMIR mental health 2019, 6: 1-13.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2024
• Primary Completion (Actual): March 31, 2024
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pain; anxiety; virtual reality; women health; UID Aplication
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: 2023/5362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Research results will be shared

Study Data/Documents

1. Informed Consent Form
   Information identifier: Bilgi Noben 1 2, Simone Maria

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No