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临床试验/NCT07065084
NCT07065084已完成不适用

The Effect of Virtual Reality Application on Pain, Anxiety and Vital Signs During the Procedure in Hernia Patients Operated With Spinal Anesthesia

Celal Bayar University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年11月24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
102
试验地点
1
主要终点
pain level

研究概览

简要总结

Abstract The aim of this study was to evaluate the effect of virtual reality application on pain, anxiety and vital signs during the procedure. This randomized controlled study included 110 hernia patients who underwent spinal anesthesia in the General Surgery Operating Room of a hospital in the western region of Turkey. Patients were randomly assigned to the experimental group or the control group. Patients in the experimental group (n=55) were shown virtual reality goggles and a music-enhanced video for 20 minutes during the surgical procedure. Patients in the control group (n=55) received standard nursing care. Patients in both groups were evaluated using VAS, State and Trait Anxiety Inventory, and Life Findings Monitoring Form.

Keywords: Virtual Reality simulation, Anxiety, Surgery, Pain, Nursing Care

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

No additional masking was applied.

入排标准

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

入选标准

  • •diagnosed with hernia spinal anesthesia used

排除标准

  • •psychiatric/mental illness vision/hearing disability general anesthesia used

研究组 & 干预措施

Study (video wathced with VR glasses)

Experimental

the patients in the intervention group were fitted with VR goggles by the researcher immediately after the spinal anesthesia was administered by the researcher during the operation in hernia patients who received spinal anesthesia for the study, when the patient was placed on the operating table and given the operating position, just before the surgical incision started. The procedures were performed without interfering with anesthesia and general operating room functioning. When the surgical incision was to be made, videos were started to be watched from the VR glasses simultaneously. During the 20 minute procedure, the licensed product "Relax with Nature" with music background with virtual reality glasses

干预措施: Virtual Reality glasses (Procedure)

Control (routine surgical procedure)

No Intervention

this group underwent a routine surgical procedure throughout the surgical intervention. No intervention was performed.

结局指标

主要结局

pain level

时间窗: preoperative and intraoperative: Two time

Patients' pain intensity was assessed intraoperatively and postoperatively using the Numerical Rating Scale (NRS). Scale scores range from 0-10. A high score indicates an increase in the patient's pain.

次要结局

  • Anxiety Level(preoperative and intraoperative: two times)

研究者

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

Dilek Çeçen Çamlı

Asist. Prof. Dr

Celal Bayar University

研究点 (1)

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