跳至主要内容
临床试验/NCT05194176
NCT05194176终止不适用

The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
1
主要终点
Inspiration volume, repeated measures over 5 days

研究概览

简要总结

Blunt chest trauma comprises over 10% of all trauma patients presenting to emergency departments worldwide and is the most frequent injury in polytrauma patients. It is associated with high risk (>10%) of pulmonary complications such as pneumonia. Pillars of treatment are adequate pain relief, respiratory function exercises and rapid mobilisation through physiotherapy. Inadequate pain control can result in restricted ventilatory function and in reduced mobility, both resulting in a higher risk of particularly pulmonary complications. Virtual Reality (VR) might be an easy to use, individualized, and harmless technique that can facilitate pulmonary recovery and aid in the prevention of complications through reducing pain and promoting exercising. The investigators hypothesize that VR improves respiratory function and mobilisation in the post-acute phase of blunt chest trauma by distracting patients from pain and stress, and by stimulating pulmonary and physical exercise.

研究设计

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

入排标准

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

入选标准

  • •Admitted to the trauma ward with sustained blunt chest trauma
  • •Patient is willing and able to comply with the study protocol

排除标准

  • •Neurotrauma with GCS ≤13
  • •History of dementia, seizures, epilepsy
  • •Severe hearing/visual impairment not corrected
  • •Head wounds or damaged skin with which comfortable and hygienic use is not possible.
  • •Stay at intensive care unit (ICU) during current hospital admission.
  • •Erect position in bed not possible/allowed.

研究组 & 干预措施

Control

No Intervention

The control group will receive usual care. Patients will be instructed to perform respiratory exercises 8 times daily for 10 minutes and to extend these exercises 2 times daily with (sitting) physical exercises for an additional 10 minutes. Respiratory exercises include using incentive spirometry and exercises for deep breathing, huffing and coughing. Patients receive a leaflet with the exercises described and the exercises will be performed once daily under supervision of a physiotherapist. The other sessions will be unsupervised.

Virtual Reality

Experimental

The intervention group will be instructed to perform the respiratory exercises using the VR-intervention 8 times daily for 10 minutes and to extend these exercises 2 times daily with (sitting) physical exercises for an additional 10 minutes. The respiratory exercises in VR are comparable to the exercises in usual care but performed in a virtual environment and without incentive spirometry. The physical exercises consist of several games through which patients are challenged to reach out to objects while engaging their core. Patients are allowed to continue these exercises or play some relaxation games for up to 30 minutes per session in total. The exercises will be performed once daily under supervision of a physiotherapist. The other sessions will be unsupervised.

干预措施: Virtual Reality (Device)

结局指标

主要结局

Inspiration volume, repeated measures over 5 days

时间窗: Twice daily from enrollment to day 5 of treatment

change in mean daily inspiration volume in mL, measured with an incentive spirometer (Voldyne)

Inspiration volume, mean change from baseline

时间窗: From baseline to end of treatment at day 5.

Mean change from baseline in inspiration volume in ml, measured with an incentive spirometer (Voldyne)

次要结局

  • Time spent sitting or standing, mean change from baseline(Continuously from enrollment to end of treatment at day 5.)
  • Length of hospital stay(At end of follow-up, 30 days after discharge)
  • Pulmonary complications during admission(At end of follow-up, 30 days after discharge)
  • Transfers to ICU(At end of follow-up, 30 days after discharge)
  • Readmission within 30 days(At end of follow-up, 30 days after discharge)
  • Pain score during breathing exercise using Visual Analogue Score (VAS)(Daily from baseline to end of treatment at day 5.)
  • Powerless in Daily living questionnaire(Daily from baseline to end of treatment at day 5.)
  • Quality of Recovery-15 questionnaire(Daily from baseline to end of treatment at day 5.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验