Viewing Study NCT05718661



Ignite Creation Date: 2024-05-06 @ 6:34 PM
Last Modification Date: 2024-10-26 @ 2:51 PM
Study NCT ID: NCT05718661
Status: RECRUITING
Last Update Posted: 2024-04-18
First Post: 2023-01-30

Brief Title: The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery
Sponsor: Trakya University
Organization: Trakya University

Study Overview

Official Title: The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery
Status: RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Hospitalization medical interventions to be performed and uncertainties specific to surgical intervention create a certain level of anxiety in the patient It is known that being in the hospital negatively affects the coping mechanisms of the patient In the pre-surgical period the nurses practices that will facilitate the patients coping with the situation and managing his anxiety have a positive effect on anxiety during and after surgery and on anxiety-related symptoms For these reasons it is aimed to determine the effect of virtual reality on pre-surgical anxiety in this studyThe hypothesis of the study is that watching videos with virtual glasses will reduce preoperative anxiety
Detailed Description: Questions to be Answered in the Study The questions expected to be answered in the study to be conducted to evaluate the effect of acupressure application on the anxiety level in the preoperative period in patients who will undergo abdominal surgery

What is the frequency of anxiety before abdominal surgery
What is the effect of virtual reality on anxiety management before abdominal surgery

Variables of the Research Preoperative anxiety scalelevel

Data Collection Tools Patient Information Form VAS-A and a smart wristband with stress level measurement feature will be used to collect data

Form-1Patient Information Form It is a form consisting of sociodemographic questions created by the researchers

Form-2 Visual Anxiety Scale VAS-A The Numerical Anxiety Severity Scale consists of a horizontal line that begins with the expression 0 or no anxiety and ends with the expression 100 or severe anxiety The patient is asked to choose the number that best describes the pain between 0 and 100 by showing the scale The result of the scale was evaluated over the arithmetic mean Carr et al 2005 Kindler et al 2000

Smart Wristband A smart wristband with photoplethysmography PPG feature that detects and reports stress-related changes will be used

After assessing whether the data fit the normal distribution with the Kolmogorov Smirnov test if the data fit the normal distribution parametric tests Single Sample t-Test One- and Multi-Way Analysis of Variance Spearmans Correlation Analysis if the data do not fit the normal distribution non-parametric tests Mann-Whitney U Test Kruskall Wallis Test Friedman Test Pearsons Correlation Analysis will be used Mean standard deviation and percentage distribution methods will be used in the descriptive analysis of the data The power of the sample will be calculated with the post hoc analysis to be made

The universe of the research Between 01032023 and 01122023 all patients who will undergo abdominal surgery in the Trakya University Health Research Center General Surgery Clinic will form

The sample of the research The sample will consist of individuals who meet the selection criteria and volunteer to participate in the research

Sample of the Study Mosso et al 2009 in the study titled Virtual reality on mobile phones to reduce anxiety in outpatient surgery in which the anxiety levels of patients who used virtual reality in the preoperative period were evaluated using VAS-A Accordingly the effect size was calculated as d0920 In the calculation of the sample size using the G-Power G-Power 3197 Kiel Germany program effect size d0920 margin of error005 power 1-β err probe095 32 patients were included in each group needed was determined Using this number For the initiative group 32 patients For the control group 32 patients For the placebo group The total number of patients to be sampled was planned to be 96 32 patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None