The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- pulse rate (heart rate)
研究概览
简要总结
The present study was conducted with 44 patients who applied to the Endoscopy Unit of a university hospital for sedation-free colonoscopy between January 2, 2020 and September 28, 2020, met the inclusion criteria and agreed to participate in the study. The patients were homogeneously divided into experimental (n=22) and control (n=22) groups based on their gender and history of colonoscopy. The patients in the experimental group watched a 360 degree virtual reailty (VR) video with atmospheric background music over images and sounds of nature through virtual reality glasses while no application was performed for the patients in the control group during the procedure. The "Demographic Information Form", "Trait Anxiety Scale", "Visual Analog Scale-Pain", "Visual Analog Scale-Anxiety", "Vital Signs Monitoring Chart" and "Satisfaction Evaluation on the Virtual Reality Glasses Application" forms were used in the data collection phase. For the study, an ethics committee approval was obtained in addition to written consent by the institutions and patients. Numbers, percentages, the Chi-square test, the Wilcoxon test and the Mann-Whitney U test were used for data analysis.
详细描述
Aims: This study investigated the effect of VR glasses on vital signs and anxiety in patients undergoing colonoscopy. The research questions are as follows:
- Wearing VR glasses during colonoscopy affects at least one vital sign.
- Wearing VR glasses during colonoscopy affects anxiety. Study design and setting: This study adopted a randomized controlled experimental design. The study population consisted of all patients (N=82) who had a colonoscopy without sedation between January 2, 2020, and September 28, 2020, at the endoscopy unit of a training and research hospital in Kırıkkale, Turkey. Patients were randomized into experimental and control groups before the procedure.
Group 1 (experimental): Virtual reality glasses have a detachable screen frame compatible with smartphones. A VR headset has earphones and sensors that track the user's head movements, giving them the impression that they are moving around in a virtual environment (Arane et al., 2017; Indovina et al., 2018). The investigators used a smartphone and VR glasses to perform the intervention. They connected the phone to the VR headset via a 360o VR video app. Experimental participants wore the VR glasses and watched a 360o VR video of nature scenes with ambiance music during colonoscopy. They put on the VR glasses right before the procedure and took them off right afterward.
Each control group participant (Group 2) underwent the standard procedure.
Sample size calculation: The sample consisted of 44 participants divided into experimental (n=22) and control (n=22). A post-power analysis was conducted on Visual Analog Scale-Pain (VAS-P) scores due to the pandemic. The results showed that the sample was large enough to detect significant differences (effect size = 1.31; type I margin of error (α) = 0.05; test power (1-β) = 0.98).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The data of the study were entered by a person other than the researcher. Statistical analysis was performed by a person other than the researcher. In the study, virtual reality glasses were worn on the participants of experimental group. For this reason, blinding could not be done for the participants. The researcher herself collected all data because the hospital restricted traffic in and out of the unit due to the pandemic. Therefore, the evaluator was not blinded to the study.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary
- •Scheduled for a colonoscopy without sedation
- •Aged 18 to 79 years
- •No perception, hearing, and vision impairment that interferes with communication
- •Not wearing glasses
- •No psychiatric disorder
- •No migraine, vertigo, active nausea, vomiting, headache, etc.
排除标准
- •no Voluntary
- •Scheduled for a colonoscopy with sedation
- •not been Aged 18 to 79 years
- •participants have been perception, hearing, and vision impairment that interferes with communication
- •wearing glasses
- •participants have psychiatric disorder
- •participants have migraine, vertigo, active nausea, vomiting, headache, etc.
研究组 & 干预措施
intervention
This study was carried out with two groups. Virtual reality glasses were used for the intervention group.
干预措施: virtual reality glasses (Other)
control
No application was made to the control group, standard procedure was followed.
结局指标
主要结局
pulse rate (heart rate)
时间窗: Change in pulse rate during colonoscopy, an average of 20 minutes
beats per minute. higher scores mean a worse
blood pressure
时间窗: Change in systolic blood pressure during colonoscopy, an average of 20 minutes
mmHg. higher scores mean a worse
peripheral oxygen saturation (SpO2)
时间窗: Change in peripheral oxygen saturation during colonoscopy, an average of 20 minutes
Approaching 100% is considered positive. higher scores mean a better
respiratory rate
时间窗: Change in respiratory rate during colonoscopy, an average of 20 minutes
respiratory rate per minute. higher scores mean a worse
Pain score
时间窗: Change in pain score during colonoscopy, an average of 20 minutes
Visual Analog Scale-Pain (VAS-P), which is a 10cm long line with anchor statements "0=no pain" at the left-most end and "10=unbearable pain" at the right-most end. minimum=0, maximum=10; higher scores mean a worse and lower scores mean a better
Anxiety score
时间窗: Change in anxiety score during colonoscopy, an average of 20 minutes
Visual Analog Scale-Anxiety (VAS-A), which is a 10 cm long horizontal line with anchor statements "0=no anxiety at all" at the left-most end and "10=worst anxiety imaginable" at the right-most end. minimum=0, maximum=10; higher scores mean a worse and lower scores mean a better
次要结局
未报告次要终点
研究者
Esra DOĞAN YILMAZ, RN, MSc
Research Assistant
Kırıkkale University