Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528925
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Effect of Virtual Reality Goggles on Pain Anxiety and Hemodynamic Variables During Urodynamics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Virtual Reality Goggles on Pain Anxiety and Hemodynamic Variables During Urodynamics a Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 d08 1- α bidirectional 95 power with reference to the effect size limit of 08 in GPower 31 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 schedulePatients 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 250 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 005 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 d08 1- α bidirectional 95 power with reference to the effect size limit of 08 in GPower 31 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 schedulePatients 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 250 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 005 will be taken as statistically significant difference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None