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临床试验/NCT06765967
NCT06765967已完成不适用

The Effect of Virtual Reality and Music Recital on Anxiety and Agitation in Patients Undergoing Spinal Anaesthesia: A Randomised Controlled Study

Kafkas University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年4月15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
108
试验地点
1
主要终点
Spinal Anaesthesia Anxiety and Agitation Scale

研究概览

简要总结

This study will be carried out in patients undergoing spinal anaesthesia. The effects of virtual reality and music playback on anxiety and agitation in patients will be evaluated.

详细描述

Virtual reality is a computer technology in which a virtual environment is simulated in three dimensions. This technology isolates the individual from real life by zooming the lenses to the patient's eyes through a headset known as virtual reality glasses. Recently, with technological developments, virtual reality applications have started to take place among nursing practices as non-pharmacological approaches that support pharmacological methods in clinical settings. Various studies have revealed that virtual reality as a distraction method plays an important role in alleviating anxiety and agitation experienced by patients.

Music application is an easy-to-apply and non-invasive non-pharmacological method. Music recitals give a feeling of relaxation by increasing the release of endorphin hormone in individuals and play an important role as a psychosocial intervention. Such activities reduce symptoms of anxiety and depression, improve quality of life and have positive effects on physical symptoms and general well-being. In addition, the effects of music on respiratory rate, blood pressure and heart rate are also observed.

This study aims to evaluate the effects of virtual reality technology and music playback on anxiety, agitation and physiological parameters in patients undergoing spinal anaesthesia and to make important contributions to the literature in this context.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

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

  • •18 years of age or older,
  • •Clear consciousness, able to communicate,
  • •No hearing-speech problems,
  • •Who volunteered to participate in the study,
  • •Patients who would undergo Urology, General Surgery, Orthopedics, Cardiovascular Surgery, Neurosurgery by spinal anaesthesia were included in the study.

排除标准

  • •Patients without spinal anaesthesia,
  • •Patients who participated in the study but voluntarily withdrew at any stage of the study or patients who had to withdraw involuntarily during the operation were not included in the study.

研究组 & 干预措施

virtual reality glasses

Experimental

Patients were shown walking in the forest, underwater life, nature landscapes and snow landscapes with virtual reality goggles.

干预措施: displaying virtual reality images (Other)

music

Experimental

Music was played to the patients with headphones.

干预措施: music playback (Other)

control

No Intervention

Patients in the normal operation process, no intervention was performed.

结局指标

主要结局

Spinal Anaesthesia Anxiety and Agitation Scale

时间窗: 1 year

to evaluate anxiety and agitation in individuals under spinal anaesthesia. Spinal Anaesthesia Anxiety Scale consists of two sub-dimensions called 'Intellectual Experience' and 'Sensory Experience' and 14 questions. The Sensory Experience sub-dimension includes eight questions and the Intellectual Experience sub-dimension includes six questions. The Spinal Anaesthesia Anxiety Scale is a 5-point Likert-type scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree). Spinal Anaesthesia Agitation Scale consisted of 9 questions and three sub-dimensions as 'Verbal Non-Aggressive Behaviours', 'Aggressive Behaviours towards Personnel' and 'Aggressive Behaviours towards Self'.

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

Semra ERDAĞI ORAL

associate professor doctor

Kafkas University

研究点 (1)

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