The Effectiveness of Virtual Reality Distraction on Preoperative Anxiety in Abdominal Surgery Patients: A Double-Blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety Level-1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Watching video with virtual glasses (Behavioral)
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.
干预措施: watching video without virtual glasses (Behavioral)
Control Group
Anxiety control will be done by the researcher (SU) for the control group.
结局指标
主要结局
Preoperative Anxiety Level-1
时间窗: 2 minutes before the intervention. Preoperative.
Visual Analogue Scale-Anxiety (VAS-A):This scale was used to evaluate patients' preoperative anxiety levels on the morning. It consists of a horizontal line on the paper with scored from "0" for "experiencing no anxiety" on the left side to "10" for " experiencing too much anxiety" on the right side.It is also reported to be valid in evaluating preoperative anxiety of surgery patients. The anxiety levels of a total of 96 patients were evaluated subjectively using the VAS-A scale. Patients marked the level of anxiety they felt on a scale
Preoperative Stress Level-1
时间窗: 2 minutes before the intervention. Preoperative.
This wearable device (smart bracelet) was used to evaluate the stress levels and heart rates of patients. It utilizes a built-in sensor to estimate users' stress levels, providing a score ranging from 1 to 100, where 1 indicates minimal stress and 100 represents very high stress. This estimation is derived from Heart Rate Variability (HRV) data. The device applies a proprietary algorithm-referred to as a stress model-to interpret HRV fluctuations and classify the user's stress level accordingly. The stress levels of a total of 96 patients were measured objectively with a smart bracelet.
Preoperative Heart Rate
时间窗: 2 minutes before the intervention. Preoperative.
This wearable device was used to evaluate the stress levels and heart rates of patients. It utilizes a built-in sensor to estimate users' stress levels, providing a score ranging from 1 to 100, where 1 indicates minimal stress and 100 represents very high stress. This estimation is derived from Heart Rate Variability (HRV) data. The device applies a proprietary algorithm-referred to as a stress model-to interpret HRV fluctuations and classify the user's stress level accordingly. The heart rate levels of a total of 96 patients were measured objectively with a smart bracelet.
次要结局
- Preoperative Anxiety Level-2(Preoperative. immediately after intervention.)
- Preoperative Stress Level(Preoperative. immediately after intervention.)
- Preoperative Heart Rate(Preoperative. immediately after intervention.)
研究者
Sevim Akbal
Assistant Professor
Trakya University