Adjunctive Virtual Reality Therapy Versus Non-Sleep Deep Rest Relaxation During Postoperative Rehabilitation in Older Adults Undergoing Hip or Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale (HADS) Total Score at 4 Weeks
研究概览
简要总结
The aim of this study is to compare the effectiveness of Virtual Reality therapy (VR therapy), Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in older adults following hip or knee arthroplasty, focusing on reducing psychological stress and improving functional recovery.
详细描述
Older adults undergoing hip or knee arthroplasty frequently experience psychological distress, including elevated stress and anxiety, which may reduce engagement in rehabilitation and limit functional recovery. This randomized clinical trial will compare the effectiveness of Virtual Reality therapy (VR therapy) and Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in this population. Ninety participants aged 60-85 years, within three months post-arthroplasty, will be recruited from an inpatient rehabilitation unit and randomized to receive standard rehabilitation alone, standard rehabilitation plus VR therapy or standard rehabilitation plus NSDR relaxation over a four-week period. The VR therapy will consist of eight 20-minute session using VRTierOne medical device. NSDR relaxation will be delivered as eight 20-minute, audio-guided relaxation sessions (body scan and breathing exercises) via noise-cancelling headphones in a quiet environment. The primary outcome was psychological distress, assessed using the HADS total score at baseline and after the 4-week intervention. Both adjuncts are designed to be safe, well-tolerated, and feasible for clinical implementation. The findings are expected to clarify the comparative role of VR therapy and NSDR relaxation as low-risk adjunctive strategies to support psychological well-being and functional outcomes during post-arthroplasty 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 60 years and above who have recently (within the past 3 months) undergone knee or hip joint arthroplasty surgery.
排除标准
- •Hearing impairment preventing the use of audio recordings;
- •Cognitive impairment precluding independent completion of study questionnaires (MMSE <24);
- •History of disorders of consciousness, psychotic symptoms, bipolar disorder, or other severe psychiatric disorders;
- •Current use of psychoactive medications;
- •Ongoing psychiatric treatment or participation in individual psychological therapy;
- •Functional status precluding independent ambulation (e.g., wheelchair-bound or bedridden; use of orthopedic aids such as crutches or a walker is permitted);
- •Withdrawal of consent or refusal to participate at any stage of the study.
研究组 & 干预措施
Immersive Virtual Reality Therapy Group
Conventional orthopedic rehabilitation supplemented by VR therapy
干预措施: Immersive Virtual Reality Therapy (Device)
Immersive Virtual Reality Therapy Group
Conventional orthopedic rehabilitation supplemented by VR therapy
干预措施: Conventional rehabilitation (Behavioral)
NSDR Group
Conventional orthopedic rehabilitation supplemented by non-sleep deep rest relaxation
干预措施: Non-Sleep Deep Rest Relaxation (Behavioral)
NSDR Group
Conventional orthopedic rehabilitation supplemented by non-sleep deep rest relaxation
干预措施: Conventional rehabilitation (Behavioral)
Conventional Rehabilitation Group
Conventional orthopedic rehabilitation
干预措施: Conventional rehabilitation (Behavioral)
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS) Total Score at 4 Weeks
时间窗: Baseline and 4 weeks
The Hospital Anxiety and Depression Scale (HADS) is a 14-item instrument assessing anxiety and depression symptoms in hospital patients. Each item is scored from 0 to 3, with total scores ranging from 0 to 42. Higher scores indicate greater symptom severity.
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score at 4 Weeks
时间窗: Baseline and 4 weeks
The Hospital Anxiety and Depression Scale (HADS) is a 14-item instrument assessing anxiety and depression symptoms in hospital patients. Each item is scored from 0 to 3, with total scores ranging from 0 to 42. Higher scores indicate greater symptom severity.
Change from Baseline in Perceived Stress Scale (PSS-10) Score at 4 Weeks
时间窗: Baseline and 4 weeks
The Perceived Stress Scale (PSS-10) is a 10-item scale measuring perceived stress over the past month. Scores range from 0 to 40, with higher scores reflecting greater perceived stress.
Change from Baseline in Generalized Self-Efficacy Scale (GSES) Score at 4 Weeks
时间窗: Baseline and 4 weeks
The Generalized Self-Efficacy Scale (GSES) is a 10-item measure of general self-efficacy, meaning a person's broad belief in their ability to cope with difficult demands and handle challenges. Items are rated on a 4-point scale and summed to a total score ranging from 10 to 40. Higher scores reflect greater generalized self-efficacy.
Change from Baseline in Perception of Stress Questionnaire (PSQ) Score at 4 Weeks
时间窗: Baseline and 4 weeks
The Perception of Stress Questionnaire (PSQ) is a 27-item measure of perceived stress, with scores ranging from 21 to 105. Higher scores reflect greater stress perception.
次要结局
- Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) Score at 4 Weeks(Baseline and 4 weeks)
- Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)(Baseline and 4 weeks)
- Modified Rivermead Motor Assessment - Gross Function (RMA-GF) Score at 4 Weeks(Baseline and 4 weeks)
- Short Physical Performance Battery (SPPB) Score at 4 Weeks(Baseline and 4 weeks)
- Barthel Index Score at 4 Weeks(Baseline and 4 weeks)
- Tinetti's Short Scale Score at 4 Weeks(Baseline and 4 weeks)
- Visual Analogue Scale (VAS) Score at 4 Weeks(Baseline and 4 weeks)
- Perceived Stress Scale (PSS-10) Score at 4 Weeks(Baseline and 4 weeks)
- Generalized Self-Efficacy Scale (GSES) Score at 4 Weeks(Baseline and 4 weeks)
- Perception of Stress Questionnaire (PSQ) Score at 4 Weeks(Baseline and 4 weeks)
- Perception of Stress Questionnaire Emotional Tension Subscale Score at 4 Weeks(Baseline and 4 weeks)
- Perception of Stress Questionnaire External Stress Subscale Score at 4 Weeks(Baseline and 4 weeks)
- Perception of Stress Questionnaire Intrapsychic Stress Subscale Score at 4 Weeks(Baseline and 4 weeks)
- Change from Baseline in Rivermead Mobility Index (RMI) Score at 4 Weeks(Baseline and 4 weeks)
- Change from Baseline in Short Physical Performance Battery (SPPB) Score at 4 Weeks(Baseline and 4 weeks)
- Change from Baseline in Barthel Index Score at 4 Weeks(Baseline and 4 weeks)
- Change from Baseline in Tinetti's Short Scale Score at 4 Weeks(Baseline and 4 weeks)
- Change from Baseline in Visual Analogue Scale (VAS) Score at 4 Weeks(Baseline and 4 weeks)
研究者
Joanna Szczepańska-Gieracha
Principal Investigator
Wroclaw University of Health and Sport Sciences