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

The EFFECT of VİRTUAL REALİTY (VR) HEADSET USE on ANXİETY LEVELS DURİNG URODYNAMİC TESTİNG; a PROSPECTİVE, RANDOMIZED CONTROLLED STUDY

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.

Study Overview

• Status: Completed
• Conditions: Virtual Reality Headsets Reduce Anxiety During Urodynamic Tests
• Intervention / Treatment: Device: Virtual reality group

Detailed Description

This study was designed as a pre-test and post-test randomized controlled trial to determine the effect of VR headset use on anxiety levels in patients undergoing urodynamic testing. Patients scheduled for urodynamic evaluation in our clinic between April 20, 2023, and June 30, 2023, were included in the study. Participants were randomized into two groups-VR and control-using the computer-based Research Randomizer program. Ethical approval for the study was obtained from the local ethics committee (2023/17).

Inclusion Criteria:

• 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

Exclusion Criteria:

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

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. In addition to these questions, the VR group was also asked whether they would prefer using a VR headset for future urodynamic procedures and whether they would recommend it to other patients.

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.18,19 At the end of the procedure, participants in both groups completed the STAI Form I again. Pre- and post-procedure scores were compared between the two groups.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey, 38000
    • Trabzon Kanuni Education and Research Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: control group; 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; 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),

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: = Not at all; = Somewhat; = Very much; = 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: = Almost never; = Sometimes; = Often; = 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

Collaborators and Investigators

• Sponsor: Trabzon Kanuni Education and Research Hospital
• Investigators: Principal Investigator: Nurten S SİBAL, Nurse, Avrasya University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Virtual reality, urodynamics, anxiety, lower urinary tract dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: E-23618724-000-213048010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: I don't have a URL address

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No