The Effect of Virtual Reality on Pain, Anxiety, and Comfort Levels After Total Hip Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of Pain in Patients After Total Hip Arthroplasty Surgery
研究概览
简要总结
Total Hip Arthroplasty (THA), a procedure performed to enhance the quality of life, is accompanied by postoperative challenges such as pain and anxiety that adversely affect patient comfort. Inadequate management of these complications can prolong the length of hospital stay, delay recovery, lead to functional impairments, and elevate the risk of chronic pain development. Conventional pharmacological interventions employed for management are limited due to their potential for adverse effects and dependency. Virtual reality (VR) is a non-pharmacological distraction technique utilized in the healthcare sector, leveraging advanced technology to maximize patient comfort by alleviating pain and minimizing anxiety.
A review of the literature reveals that while the use of VR has positive effects on pain and anxiety, there is a notable scarcity of high-quality randomized controlled trials concurrently evaluating its impact on pain, anxiety, and comfort levels in postoperative orthopedic procedures such as THA. In this randomized controlled trial, participants in the control group will receive standard care, whereas those in the experimental group will receive a 30-minute VR intervention-offering three distinct options-in addition to standard care during the acute phase of the first 48 hours. Postoperative assessments will be conducted using the Visual Analogue Scale (VAS) for pain intensity, the State Anxiety Inventory for anxiety levels, and the Perianesthesia Comfort Scale for comfort levels.
By evaluating the potential of VR as a non-pharmacological adjuvant in post-THA care, the findings of this study will provide significant contributions to evidence-based nursing practices aimed at developing multimodal pain management strategies, reducing opioid consumption, and enhancing patient satisfaction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective surgery who agree to participate in the study,
- •Individuals 18 years of age or older,
- •Those with adequate cognitive function,
- •Those who have not previously undergone total hip replacement surgery,
- •Those who volunteer to participate in the study and sign the informed consent form,
- •Patients with a pain score (on a scale of 1 to 10) of 4 or higher were included in the study.
排除标准
- •Individuals under the age of 18,
- •Those previously diagnosed with a chronic pain syndrome (other than hip osteoarthritis),
- •Individuals with impaired cognitive function (severe psychiatric disorders),
- •Individuals who have previously undergone total hip replacement surgery,
- •Individuals with severe hearing or visual impairments,
- •Individuals with a history of opioid dependence,
- •Patients with a pain score (on a scale of 1 to 10) of 4 or lower were excluded from the study.
结局指标
主要结局
Evaluation of Pain in Patients After Total Hip Arthroplasty Surgery
时间窗: The first 24 hours after surgery, 25-48 hours after surgery
The Visual Analog Scale (VAS) was used to measure pain intensity; it is a simple, unidimensional measure. It was developed by Price et al. in 1983 to assess perceived pain. Compared to the VAS scale, which is known to be more sensitive in the assessment and characterization of acute pain, "no pain" is rated as 0 points and "most severe pain" as 10 points. On this scale, an increase in score indicates an increase in pain. Pain is also categorized as mild (\<3), moderate (3-6), and severe (\>6).
Evaluation of Anxiety in Patients After Total Hip Arthroplasty Surgery
时间窗: The first 24 hours after surgery, 25-48 hours after surgery
The Spielberger State-Trait Anxiety Inventory was used to assess patients' anxiety levels. The original scale was developed in 1970 by Spielberger and his team and adapted to the Turkish language and culture by Öner and Le Compte. Scale items are answered on a four-point Likert-type scale. For the state anxiety scale, the response options are "not at all," "a little," "a lot," and "completely," while for the trait anxiety scale, they are "never," "sometimes," "most of the time," and "almost always." Higher scores on the scale indicate higher levels of anxiety, while lower scores indicate lower levels of anxiety. According to the score ranges established by Spielberger and colleagues, a score of 0-19 indicates no anxiety, 20-39 indicates mild anxiety, 40-59 indicates moderate anxiety, and 60-79 indicates severe anxiety.
Evaluation of Comfort Levels in Patients After Total Hip Arthroplasty Surgery
时间窗: The first 24 hours after surgery, 25-48 hours after surgery
The comfort levels of postoperative patients were assessed using the Perianesthesia Comfort Scale. The scale was developed by Kolcaba in 1990 and adapted into Turkish by Üstündağ and Aslan (2010). The Perianesthesia Comfort Scale (PCS) is a self-report assessment tool designed to measure individuals' comfort levels during the perianesthesia period. The scale consists of a total of 24 items and uses a six-point Likert-type scale. Participants respond to each item with scores ranging from "strongly disagree (1)" to "strongly agree (6)." The total score that can be obtained from the scale ranges from 24 to 144. The total score is divided by the number of items to calculate the mean score, which is expressed as a value between 1 and 6. A low mean score indicates a low level of comfort, while a high mean score indicates a high level of comfort.
次要结局
未报告次要终点
研究者
Oğuzhan Çağlar
Research Assistant
Adiyaman University