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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2024-12-20

Brief Summary

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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.

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Detailed Description

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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

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This research was designed using the experimental (intervention) research method. Under the same environment and conditions, to determine the effect on the same dependent variable, the intervention (experimental) group using virtual reality and the placebo group not using virtual reality (watching the same video with the naked eye), pre-test (measurement of the dependent variable before the intervention), post-test (dependent measurement of the variable after intervention). In addition, the group that was not interfered with will form the control group and a data collection form will be applied with an interval of 30 minutes.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

The evaluation process consisted of two stages: the first evaluation conducted in the morning and the second evaluation performed immediately before the patients were transferred to the operating room. To maintain blinding during the data collection, the patient information, anxiety and stress levels of the patients were evaluated by three senior nursing student researchers.

Study Groups

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Virtual Reality Glasses Group

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.

Group Type EXPERIMENTAL

Watching video with virtual glasses

Intervention Type BEHAVIORAL

Using 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.

Non-Virtual Reality Glasses Group

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.

Group Type PLACEBO_COMPARATOR

watching video without virtual glasses

Intervention Type BEHAVIORAL

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.

Control Group

Anxiety control will be done by the researcher (SU) for the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Watching video with virtual glasses

Using 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.

Intervention Type BEHAVIORAL

watching video without virtual glasses

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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 undergoing unplanned or emergency surgery

Patients in isolation

Patients with visual and/or auditory impairments

Patients with neurological conditions such as vertigo

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No