Effect of Virtual Reality Goggles on Pain, Anxiety and Hemodynamic Variables During Urodynamics
- Conditions
- UrodynamicsAnxietyVirtual GogglesPainHemodynamic Variables
- Interventions
- Other: Virtual reality goggles
- Registration Number
- NCT06528925
- Lead Sponsor
- Tarsus University
- 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
- Detailed Description
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 population of the study, which is planned as a randomized controlled experimental study, will consist of patients who apply to the Urology Outpatient Clinic of Mersin University Hospital and will undergo 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. Pearson-χ2 test will be used for categorical variables. 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EXPERIMENTAL GROUP Virtual reality goggles 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.
- Primary Outcome Measures
Name Time Method Pain score 7 months 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).
Hemodynamic Variables 7 months 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
Anxiety 7 months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mersin University
🇹🇷Mersin, Turkey