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临床试验/NCT06882382
NCT06882382已完成不适用

Effects of Early Mobilization With Virtual Reality on Postoperative Respiratory Function, Exercise Capacity, and Pain in Children: A Randomized Controlled Trial

Mustafa Kemal University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年10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
27
试验地点
1
主要终点
forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), ratio of forced expiratory volume in the first second to FVC (FEV1/FVC), peak expiratory flow rate (PEF), and forced mid-expiratory flow rate (FEF 25-75%)

研究概览

简要总结

Aim: Early mobilization and exercise after surgery are very important to reduce the impact on lung function. The aim of this study was to compare the effects of early mobilization with virtual reality and conservative physiotherapy methods on pulmonary function, dyspnea, exercise capacity, pain, and kinesiophobia in children undergoing surgery.

Methods: The study included 27 children aged 5-18 years who underwent surgery. Among the children randomly divided into two groups, the control group (n = 14) received physiotherapy for 40 min twice a day for 3 days in the hospital after surgery, and the children were mobilized in and out of bed. In the virtual reality group (n = 13), in addition to physiotherapy practices, children were allowed to play virtual reality games for 20 min twice a day. Respiratory function, exercise capacity, and pain assessment were performed before surgery and before discharge.

详细描述

Aim: Early mobilization and exercise after surgery are very important to reduce the impact on lung function. The aim of this study was to compare the effects of early mobilization with virtual reality and conservative physiotherapy methods on pulmonary function, dyspnea, exercise capacity, pain, and kinesiophobia in children undergoing surgery.

Methods: The study included 27 children aged 5-18 years who underwent surgery. Among the children randomly divided into two groups, the control group (n = 14) received physiotherapy for 40 min twice a day for 3 days in the hospital after surgery, and the children were mobilized in and out of bed. In the virtual reality group (n = 13), in addition to physiotherapy practices, children were allowed to play virtual reality games for 20 min twice a day. Respiratory function, exercise capacity, and pain assessment were performed before surgery and before discharge.

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
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Between the ages of 5 and 18 undergone surgery for inguinal hernia, undescended testicle, hydrocele, cord cyst, umbilical hernia, circumcision, and distal hypospadias

排除标准

  • •Children have visual and auditory sensory problems who required immobilization after surgery and had a chronic disease that would affect pulmonary function

研究组 & 干预措施

control group

Experimental

Only conventional physiotherapy was applied to this group, including normal joint movements, chest physiotherapy, and mobilization for 40 min each,

干预措施: conventional physiotherapy (Other)

virtual reality group

Experimental

The CG received conventional physiotherapy, including normal joint movements, chest physiotherapy, and mobilization for 40 min each, whereas the other group received 20 min of VR application every day in addition to conventional physiotherapy interventions.

干预措施: Virtual reality (Other)

结局指标

主要结局

forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), ratio of forced expiratory volume in the first second to FVC (FEV1/FVC), peak expiratory flow rate (PEF), and forced mid-expiratory flow rate (FEF 25-75%)

时间窗: 4 days

The pulmonary function test was measured using a portable spirometer. According to American Torasic Society/European Respiratory Society (ATS/ERS) criteria, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), ratio of forced expiratory volume in the first second to FVC (FEV1/FVC), peak expiratory flow rate (PEF), and forced mid-expiratory flow rate (FEF 25-75%) were measured. The test was performed in the sitting position. The best of at least three technically acceptable manoeuvres with 95% agreement with each other was selected for statistical analysis.

次要结局

  • Respiratory muscle strength Assessment(4 days)
  • 10 MWT test(4 days)
  • Modified Borg Scale(4 days)
  • Timed Up and Go Test(4 days)
  • Numerical Pain Scale(4 days)
  • Kinesiophobia(4 days)
  • The 1-min step(4 days)
  • BMI(measured once, independent of time)

研究者

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

Sabiha Bezgin

Mustafa Kemal University

Mustafa Kemal University

研究点 (1)

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