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临床试验/NCT06506760
NCT06506760已完成不适用

The Impact of Immersive Virtual Reality Therapy on Psychological and Functional Status in Female Patients Undergoing Inpatient Rehabilitation Following Hip Arthroplasty: A Randomized Controlled Pilot Study

Wroclaw University of Health and Sport Sciences2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
2
主要终点
Hospital Anxiety and Depression Scale

研究概览

简要总结

This study compares the effects of cardiological rehabilitation enhanced with virtual reality (VR) versus conventional rehabilitation methods. It assesses the impact on both psychological parameters (including depression, stress, anxiety, and kinesiophobia) and physiological and functional parameters of cardiology patients. The aim is to analyze the efficacy and benefits of VR-supported rehabilitation in improving patients' mental and physical health compared to traditional methods.

详细描述

The study will involve elderly female patients aged 60 and above who present sequentially at the Rehabilitation Department of St. Hedwig of Silesia Hospital in Trzebnica (Poland) within three months following hip joint arthroplasty surgery. Participants will be randomly assigned to one of two groups: Group A, the Virtual Reality Group, will receive 8 therapy sessions, with two sessions per week; Group B, the Control Group, will undergo conventional rehabilitation.

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
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female individuals who have recently undergone hip joint arthroplasty surgeries aged 60 years and above.

排除标准

  • cognitive impairments that prevent independent completion of research questionnaires
  • reported consciousness disorders
  • bipolar affective disorder and other serious mental disorders in the patient's medical history
  • use of psychoactive drugs
  • ongoing psychiatric treatment or individual psychological therapy
  • contraindications to Virtual Reality such as epilepsy, vertigo, serious vision disorders
  • functional status preventing independent movement (orthopedic aids are allowed, e.g., crutches, walker)
  • refusal to participate in the study at any stage

结局指标

主要结局

Hospital Anxiety and Depression Scale

时间窗: Baseline and 4 weeks

The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms.

次要结局

  • Perceived Stress Scale(Baseline and 4 weeks)
  • Rivermead Mobility Index(Baseline and 4 weeks)
  • Generalized Self-Efficacy Scale(Baseline and 4 weeks)
  • Tinetti's Short Scale(Baseline and 4 weeks)
  • Short Physical Performance Battery(Baseline and 4 weeks)
  • Barthel Index(Baseline and 4 weeks)
  • Perception of Stress Questionnaire(Baseline and 4 weeks)

研究者

发起方
Wroclaw University of Health and Sport Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanna Szczepańska-Gieracha

Professor

Wroclaw University of Health and Sport Sciences

研究点 (2)

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