Clinical Trials Directory

Trials / Completed

CompletedNCT05718661

The Effect of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients

The Effectiveness of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients: A Double-Blinded Randomised Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
96 (actual)
Sponsor
Trakya University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 nurse's practices that will facilitate the patient's 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 study.The hypothesis of the study is that watching videos with virtual glasses will reduce preoperative anxiety.

Detailed description

Hypothesis H1: The anxiety level of patients who watch relaxing video through VR is lower than that of those who do not. H2: The stress level of patients who watch relaxing video through VR is lower than that of those who do not. H3: The heart rate level of patients who watch relaxing video through VR is lower than that of those who do not. This study was carried out between January 30, 2023 and December 20th 2024 at the General Surgery Service of a university hospital, which has a 48-bed capacity and accommodates 1-2 patients per room. The hospital is situated in the Trakya region of the Edirne province in Türkiye and serves as a major healthcare provider, offering a comprehensive range of medical services to the surrounding provinces and contributes to medical and health sciences education and research. At this service, nurses ensure that patients are prepared for surgery in accordance with the daily determined operating room schedule by instructing them to remove their clothing, except for their underwear, and put on their green surgical gowns and caps. Following this preparation, patients remain in their beds while awaiting the arrival of healthcare support personnel for their transfer to the operating room. This waiting period typically lasts between 20 to 25 minutes. The sample size was calculated based on the study by Mosso et al. (2009) that evaluated the effect of virtual reality intervention on patients' anxiety levels in the preoperative period. An effect size of d=0.920 was obtained by comparing the pre- and post-interventional VAS-A score changes of the intervention group (2.2±2.94) and the control group (5.27±3.69). The G-Power software (G-Power 3.1.9.7, Kiel, Germany) was used for the sample size calculation, applying an effect size of d=0.920, an alpha error probability of 0.05, and a statistical power of (1-β err prob) = 0.95. As a result, a total of 96 patients were enrolled in the study, with 32 patients allocated to each group. Patients aged ≥ 18 years, scheduled for elective abdominal surgery (including appendectomy, ileal/bowel surgery, hernia repair surgery, gallbladder/pancreas surgery) waiting at the service to be transferred to the operating room in the morning of surgery, and able to communicate and provide informed consent. Patients scheduled to undergo abdominal cancer surgery, those requiring unplanned surgery such as emergency cases, those in isolation, those with visual and/or auditory disabilities, and those with neurological problems such as vertigo were excluded. In this study, data were collected using "Patient Information Form", "Visual Analog Scale-Anxiety (VAS-A)", and "Smart Bracelet".

Conditions

Interventions

TypeNameDescription
BEHAVIORALWatching video with virtual glassesUsing Mobile Virtual Glasses; In the preoperative period, after the patient is taken to the surgical service, a virtual reality video will be watched with mobile virtual glasses at the specified time (before going to the operating room on the day of surgery). Measurements will be made before and after the application. Necessary hygiene will be provided before the use of glasses, and the researcher will ensure hand cleaning before entering the patient's room.
BEHAVIORALwatching video without virtual glassesThe plain version of the video, which was shown to the intervention group by the researcher (SŞ) to the placebo group, will be watched over the phone with the naked eye and the stress level on the smart bracelet will be recorded.

Timeline

Start date
2023-01-30
Primary completion
2024-12-20
Completion
2024-12-20
First posted
2023-02-08
Last updated
2026-01-23

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05718661. Inclusion in this directory is not an endorsement.