跳至主要内容
临床试验/CTRI/2024/10/075276
CTRI/2024/10/075276尚未招募2 期

Effect of virtual reality intervention on anxiety in mechanically ventilated patients following neurosurgical procedures: A randomized controlled trial

All India Institute of Medical Sciences, Bhubaneswar1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年10月30日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
170
试验地点
1
主要终点
To compare the anxiety levels in postoperative neurosurgery patients receiving VRI versus routine ICU care.

研究概览

简要总结

Anxiety is a state marked by apprehension, agitation, increased activity, fearful withdrawal, and autonomic activity . Persistent anxiety might make it harder to focus, relax, and rest. Thus, anxiety aggravated by fear causes increased sympathetic activation, increased work of breathing, increased oxygen demand, and myocardial stimulation. Patients experience significant levels of anxiety in the ICU while on mechanical ventilation . Furthermore, excess use of sedations like benzodiazepines for anxiety control is a risk factor for chronic depression and anxiety disorders in patients who have been discharged from the ICU . Patients on mechanical ventilation feel anxious for many reasons, like acute anxiety brought on by dyspnea, discomfort from endotracheal tubes, a sense of helplessness, and fears related to their underlying diseases. Pharmacotherapies like benzodiazepines and opioids are the mainstay of managing anxiety and endotracheal tube intolerance. All pharmacotherapy has unfavorable side effects, alters assessment of consciousness (GCS), delays extubation and increases the risk of developing delirium. Research on ventilator weaning was primarily focused on physiological variables and the use of different modes of ventilation. The impact of mental well-being on ventilator weaning is less investigated. While some alternatives, such as music control, have been explored for anxiety control in ICU patients, there remain few other options for non-pharmacological methods.

The use of virtual reality in the ICU reduces anxiety and sedative requirements in non-ventilator patients. We want to explore the feasibility of VR for anxiolysis in patients on mechanical ventilation using a prospective trial. There is no data on the use of VR to reduce anxiety and facilitate extubation in the neurosurgical ICU.

We aim to compare the anxiety levels of postoperative neurosurgical patients on a mechanical ventilator receiving VRI versus routine ICU care and its effect on time to  extubation .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Mechanically ventilated patients who are awake and can communicate with researchers.
  • Expected early liberation from the ventilator in the postoperative period.

排除标准

  • 1.Patients with delirium.
  • 2.History of cybersickness or preexisting symptoms of cybersickness
  • Incision site precluding pain free use of VR visor head strap.
  • 4.Preexisting auditory or visual impairment .

结局指标

主要结局

To compare the anxiety levels in postoperative neurosurgery patients receiving VRI versus routine ICU care.

时间窗: The study will begin at the point when the patient regains consciousness as baseline data while on mechanical ventilation and will conclude at the time of extubation .

次要结局

  • 1.To compare the anxiety scores in the patients with nasal versus oral endotracheal tube with VRI in first hour of regaining consciousness.(2.To compare the time taken to extubate in patients receiving VRI & routine ICU after regaining consciousness.)

研究者

发起方
All India Institute of Medical Sciences, Bhubaneswar
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr GOBINATH J

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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