Clinical trial NCT06905665: The EFFECT of VİRTUAL REALİTY (VR) HEADSET USE on ANXİETY LEVELS DURİNG URODYNAMİC TESTİNG
Official title: The EFFECT of VİRTUAL REALİTY (VR) HEADSET USE on ANXİETY LEVELS DURİNG URODYNAMİC TESTİNG; a PROSPECTİVE, RANDOMIZED CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality Headsets Reduce Anxiety During Urodynamic Tests
Keywords: Virtual reality, urodynamics, anxiety, lower urinary tract dysfunction
Lead sponsor: Trabzon Kanuni Education and Research Hospital
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI I-II)
timeFrame: 1 (one) day
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Trabzon Kanuni Education and Research Hospital
Study officials:
affiliation: Avrasya University
name: Nurten S SİBAL, Nurse
role: PRINCIPAL_INVESTIGATOR
References: