跳至主要内容
临床试验/NCT06883916
NCT06883916已完成不适用

Effect of Virtual Reality Environment Created in Preoperative Area and Hand Massage on Patient Outcomes

Cukurova University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Surgical Anxiety Scale

研究概览

简要总结

The aim of this study is to investigate the effects of video watching with virtual reality glasses and classical hand massage on patient outcomes in patients undergoing elective surgery. In addition, it's examined that if virtual reality glasses and hand massage execution is convenient way of to reduce anxiety in patients before surgery.

The main questions it aims to answer are:

  • Is there a significant difference between the study groups in terms of post-application anxiety level?
  • Is there a significant difference between the study groups in terms of post-application vital signs, pain and patient satisfaction? Researchers will compare responses to anxiety scales before and after the hand massage and virtual reality videos to see if they reduce anxiety levels.

Participants will:

  • In the virtual reality group, they will answer the questions on the surgical anxiety scale, watch the video with VR glasses and answer the questions on the scale again.
  • In the massage group, they will answer the questions on the surgical anxiety scale, and after the researcher gives them a hand massage, they will answer the questions on the scale again.

详细描述

Surgical Anxiety Scale: The scale was developed by Burton et al. in 2018 to assess preoperative anxiety levels. Each item of the 17-item scale is answered between 0 and 5 points. It consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. Health-related anxiety is calculated by adding the scores given to items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by adding the scores given to items 2, 14, 16, and 17; and procedure-related anxiety is calculated by adding the scores given to items 1, 3, 4, and 5. The total score of the scale is calculated by adding the scores of all sub-dimensions and the scores of the three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. Although there is no cut-off point for the scale, it can be said that surgical anxiety increases as the total score of the scale increases.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who will undergo elective surgery and whose general condition is ASA (American Society of Anesthesiology) classification I, II or III
  • •Patients who are not sedated
  • •Patients over the age of 18
  • •Patients without a psychiatric or behavioral diagnosis
  • •Patients who do not have a communication barrier due to hearing loss or spoken language

排除标准

  • •Vertigo and motion sickness
  • •Carpal tunnel syndrome
  • •Hand cuts

研究组 & 干预措施

Virtual Reality

Experimental

Patients in the preoperative waiting unit were shown a video using virtual reality glasses for 10 minutes.

干预措施: Virtual reality tour (Behavioral)

Massage

Experimental

A hand massage lasting 5 minutes was applied to each hand by the researcher.

干预措施: Massage (Behavioral)

结局指标

主要结局

Surgical Anxiety Scale

时间窗: The Surgical Anxiety Scale will be administered 5 minutes before the intervention assigned to the research groups (pre-test) and again 5 minutes after the completion of the massage or virtual reality intervention (post-test).

The scale was developed by Burton et al. in 2018 to assess preoperative anxiety levels. Each item of the 17-item scale is answered between 0 and 5 points. It consists of three sub-dimensions reflecting individuals' health status, recovery process, and anxiety about procedures. Health-related anxiety is calculated by summing up items 7, 8, 9, 10, 12, and 13; recovery-related anxiety is calculated by summing up items 2, 14, 16, and 17; and procedure-related anxiety is calculated by summing up items 1, 3, 4, and 5. The total score of the scale is calculated by summing up all sub-dimension scores and the scores of three items not included in the sub-dimensions. A minimum of 0 and a maximum of 68 points can be obtained from the scale. A high total scale score indicates increased surgical anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nursevim Aydıngülü

Principal Investigator

Cukurova University

研究点 (1)

Loading locations...

相似试验