The EFFECT of VİRTUAL REALİTY (VR) HEADSET USE on ANXİETY LEVELS DURİNG URODYNAMİC TESTİNG

NCT06905665 | Completed

• 1 other identifier: E-23618724-000-213048010
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized trial tested if VR headsets reduce anxiety during urodynamic tests. First-time adult patients (18-70) were split into VR (nature videos) and control groups, with anxiety measured before and after using standard surveys. Results will show if VR offers drug-free anxiety relief for this procedure.

Conditions

Virtual Reality Headsets Reduce Anxiety During Urodynamic Tests

Keywords

Virtual reality, urodynamics, anxiety, lower urinary tract dysfunction

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Inventory (STAI I-II)

  The STAI I-II was developed by Spielberger et al. in 1970 to separately measure state and trait anxiety levels. This inventory consists of two separate scales, each containing 20 items, with some questions assessing negative emotions and others evaluating positive emotions. The STAI-I measures state anxiety by asking individuals to rate their anxiety level at a specific time under specific conditions using a four-point Likert scale: 1. = Not at all 2. = Somewhat 3. = Very much 4. = Completely The total score represents the individual's state anxiety level at that moment. The STAI-II assesses trait anxiety by evaluating how individuals generally feel, independent of their current situation. Participants rate the frequency of their anxiety using the following scale: 1. = Almost never 2. = Sometimes 3. = Often 4. = Almost always Each scale consists of 20 questions, with scores ranging from 20 to 80, where higher scores indicate higher anxiety levels.

  1 (one) day

Study Arms (1)

control group

OTHER

For the control group, no additional interventions were applied beyond the routine procedure. Before the procedure, participants completed the Data Collection Form and the State-Trait Anxiety Inventory (STAI I-II). The Data Collection Form included 14 questions designed to gather demographic and clinical characteristics such as gender, height, weight, age, marital status, education level, employment status, smoking and alcohol consumption, income level, presence of chronic diseases, history of previous surgeries, history of prior urodynamic testing, coping strategies used during anxiety, and prior knowledge of the urodynamic procedure, including the source of their information

Device: Virtual reality group

Interventions

Virtual reality group DEVICE

For the VR group, the purpose of the study was explained before the procedure, and both verbal and written informed consent were obtained. Additionally, patients were provided with detailed information about how to use the headset, what to expect, and the content of the video before viewing. Data collection forms and the State-Trait Anxiety Inventory (STAI I-II) were completed using a face-to-face interview technique before the procedure.During the urodynamic procedure, an Efnan G04EA VR Shinecon 3D headset was used. The patient was positioned appropriately on the examination table, and the VR headset was fitted onto their head with a smartphone placed inside. A thin pillow was placed under the patient's head, and efforts were made to ensure their privacy and comfort. Throughout the urodynamic procedure (approximately 30 minutes),

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18-70 undergoing urodynamic testing for the first time
• Individuals with the mental capacity to decide whether they wish to participate in the study
• No communication difficulties

You may not qualify if:

• Use of any psychiatric medication
• Individuals with visual impairments
• Individuals with speech disorders
• Individuals experiencing complications during the urodynamic procedure
• Withdrawal from the study

Sponsors & Collaborators

• Trabzon Kanuni Education and Research Hospital: lead

Study Sites (1)

Trabzon Kanuni Education and Research Hospital

Trabzon, Turkey, 38000, Turkey (Türkiye)

Location

Related Publications (1)

• Sibal NS, Sibal I, Aksoy HZ, Aydin HR, Ozoran Y, Sekerci CA. The Effect of Virtual Reality Headset Use on Anxiety Levels During Urodynamic Testing: A Prospective, Randomized Controlled Study. Urology. 2025 Dec;206:48-55. doi: 10.1016/j.urology.2025.08.002. Epub 2025 Aug 6.

  PMID: 40780518 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nurten S SİBAL, Nurse

  Avrasya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NURSE

Model Details: During the urodynamic procedure, an Efnan G04EA VR Shinecon 3D headset was used. The patient was positioned appropriately on the examination table, and the VR headset was fitted onto their head with a smartphone placed inside. A thin pillow was placed under the patient's head, and efforts were made to ensure their privacy and comfort. Throughout the urodynamic procedure (approximately 30 minutes), patients watched pre-recorded 360-degree nature scenery videos via YouTube. Care was taken to exclude any visual or auditory stimuli that could influence urodynamic results (e.g., sounds of water, rivers, waterfalls, streams). Patients were informed that they could remove the headset at any time if they experienced discomfort.

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: April 20, 2023
• Primary Completion: June 20, 2023
• Study Completion: September 20, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)