Effect of Virtual Reality Goggles on Pain, Anxiety and Hemodynamic Variables During Urodynamics

NCT06528925 | Completed

• 1 other identifier: TU-BOZKUL-008
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The research was planned as a randomized controlled experimental study to determine the effect of virtual reality goggles on pain, anxiety and hemodynamic variables during urodynamics. The minimum sample size was calculated as 42 in each group with d=0.8, (1- α, bidirectional), 95% power with reference to the effect size limit of 0.8 in G\*Power (3.1) program. Descriptive Information Form, Visual Analog Scale, State Anxiety Scale and Hemodynamic Variables Monitoring Form will be used to collect research data. The individuals in the sample group will be informed about the method followed in the application and the research and their verbal and written permissions will be obtained. Introductory Information Form, Visual Analog Scale, State Anxiety Scale and Hemodynamic Variables Monitoring Form will be completed. After the forms are applied to the patients and recorded, it will be determined whether they will be in the study or control group according to the randomization schedule.Patients in the study group will be shown videos with virtual reality glasses during the procedure. Nature landscapes with relaxing music background will be watched with virtual reality goggles by adjusting the volume at the level desired by the patient. Virtual reality goggles will be applied during the urodynamic procedure. The control group will receive routine care. After the virtual reality application, pain, anxiety levels and hemodynamic variables will be re-evaluated immediately and 15 minutes after the procedure. The data obtained in the study will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean and standard deviation) will be used to evaluate the data. Parametric and nonparametric tests will be used according to the suitability of the data used for normal distribution. P \< 0.05 will be taken as statistically significant difference

Conditions

Virtual Goggles; Urodynamics; Pain; Anxiety; Hemodynamic Variables

Outcome Measures

Primary Outcomes (3)

• Pain score

  Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).

  7 months

• Anxiety

  The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.

  7 months

• Hemodynamic Variables

  Hemodynamic Variables Monitoring Form : In this form, hemodynamic variables of the study and control groups measured before, immediately after and 15 minutes after the procedure will be recorded. Patient values will be measured and recorded by the investigator

  7 months

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

After the forms are applied to the patients and recorded, it will be determined whether they will be in the study or control group according to the randomization schedule. Patients in the study group will be shown a video with virtual reality glasses during the procedure. Patients will be asked to wear a virtual reality goggle (VR Box Virtual Reality Headset 3D Vr Glasses V2.0 2020 model) that is compatible with a mobile phone (Xiaomi Redmi Note 8 Pro 2019 model) with android operating system and minimizes sound loss in the supine position. With the virtual reality glasses, nature landscapes with relaxing music background will be watched by adjusting the volume at the level desired by the patient. Virtual reality glasses will be applied during the urodynamics procedure. After the device is applied to each patient, it will be disinfected in accordance with the company's recommendation.

Other: Virtual reality goggles

CONTROL GROUP

NO INTERVENTION

The control group will receive routine care.

Interventions

Virtual reality goggles OTHER

Patients in the study group will be shown a video with virtual reality glasses during the procedure. Patients will be asked to wear a virtual reality goggle (VR Box Virtual Reality Headset 3D Vr Glasses V2.0 2020 model) that is compatible with a mobile phone (Xiaomi Redmi Note 8 Pro 2019 model) with android operating system and minimizes sound loss in the supine position. With the virtual reality glasses, nature landscapes with relaxing music background will be watched by adjusting the volume at the level desired by the patient. Virtual reality goggles will be applied during the urodynamic procedure.

EXPERIMENTAL GROUP

Eligibility Criteria

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

You may qualify if:

• Who agreed to participate in the study,
• between the ages of 18-65
• Conscious, oriented and cooperative,
• No communication problems,
• undergoing invasive urodynamics,
• No physical problems that would prevent the application of virtual reality goggles,
• No previous experience with virtual reality glasses,
• Undiagnosed anxiety,
• No medication for anxiety
• Patients without mental disorders

You may not qualify if:

• Who did not agree to participate in the study,
• Under 18 or over 65 years of age,
• Conscious, oriented and uncooperative,
• Communication problems,
• No invasive urodynamics procedure,
• Physical problem that would prevent the application of virtual reality goggles,
• Diagnosed with anxiety,
• Taking medication for anxiety (anxiolytics, antidepressants, antipsychotics, etc.),
• Patients with mental disorders

Sponsors & Collaborators

• Tarsus University: lead
• Mersin University: collaborator

Study Sites (1)

Mersin University

Mersin, Turkey, 33400, Turkey (Türkiye)

Location

Related Publications (5)

• Biardeau X, Lam O, Ba V, Campeau L, Corcos J. Prospective evaluation of anxiety, pain, and embarrassment associated with cystoscopy and urodynamic testing in clinical practice. Can Urol Assoc J. 2017 Mar-Apr;11(3-4):104-110. doi: 10.5489/cuaj.4127.

  PMID: 28515809 BACKGROUND

• Dogan Yilmaz E, Unlusoy Dincer N. The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):318-328. doi: 10.1097/SGA.0000000000000733. Epub 2023 Jun 5.

  PMID: 37278621 BACKGROUND

• Drake MJ, Doumouchtsis SK, Hashim H, Gammie A. Fundamentals of urodynamic practice, based on International Continence Society good urodynamic practices recommendations. Neurourol Urodyn. 2018 Aug;37(S6):S50-S60. doi: 10.1002/nau.23773.

  PMID: 30614058 BACKGROUND

• Gammie A, Drake MJ. The fundamentals of uroflowmetry practice, based on International Continence Society good urodynamic practices recommendations. Neurourol Urodyn. 2018 Aug;37(S6):S44-S49. doi: 10.1002/nau.23777.

  PMID: 30614059 BACKGROUND

• Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.

  PMID: 35397973 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gülay Altun Uğraş

  Mersin University

  PRINCIPAL INVESTIGATOR

• Elife KETTAŞ DÖLEK

  Mersin Unıversity Hospital

  PRINCIPAL INVESTIGATOR

• Murat BOZLU

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The information showing that the patients included in the research sample are assigned to group A and B according to the randomization table will be placed in an opaque envelope. This envelope will be kept by the researcher (GAU) and when the researchers (GB and EKD) go to the patient for the application, they will open the envelope after filling out the "Informed Consent Form" and learn which group the patient is in. While the researchers (GB and EKD) will be blinded in assigning the patients to the groups, they will not be blinded in the application and evaluation phase due to the application of virtual reality glasses. When the research is completed, the data will be transferred to the computer environment by a statistician who does not know the A and B groups, and the data will be analyzed by a statistician independent of the research and the findings will be reported. Thus, the data analysis and statistics phase will also be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Research Assistant

Model Details: The study was planned as a prospective, two-arm (1:1), randomized controlled trial.

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start: August 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: February 15, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)