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

T

Trakya University

Status

Completed

Conditions

Anxiety

Treatments

Behavioral: Watching video with virtual glasses
Behavioral: watching video without virtual glasses

Study type

Interventional

Funder types

Other

Identifiers

NCT05718661
TUTF-GOBAEK 2022/240

Details and patient eligibility

About

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.

Full 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".

Enrollment

96 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Patients aged ≥ 18 years

Scheduled for elective abdominal surgery (e.g., appendectomy, ileal/bowel surgery, hernia repair, gallbladder/pancreas surgery)

Awaiting transfer to the operating room on the morning of surgery

Able to communicate effectively

Able to provide informed consent

Exclusion Criteria Patients scheduled for abdominal cancer surgery

Patients undergoing unplanned or emergency surgery

Patients in isolation

Patients with visual and/or auditory impairments

Patients with neurological conditions such as vertigo

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 3 patient groups, including a placebo group

Virtual Reality Glasses Group
Experimental group
Description:
The intervention group will watch a virtual reality video with mobile virtual glasses by the researcher (SŞ) and the stress level on the smart wristband will be recorded. In addition, necessary variables will be recorded with the data collection form.
Treatment:
Behavioral: Watching video with virtual glasses
Non-Virtual Reality Glasses Group
Placebo Comparator group
Description:
The 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. In addition, necessary variables will be recorded with the data collection form.
Treatment:
Behavioral: watching video without virtual glasses
Control Group
No Intervention group
Description:
Anxiety control will be done by the researcher (SU) for the control group.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Sevim Sen, PhD; Seher Unver, PhD

Data sourced from clinicaltrials.gov

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