Adjunctive Virtual Reality Therapy Versus Non-Sleep Deep Rest Relaxation During Postoperative Rehabilitation in Older Adults Undergoing Hip or Knee Arthroplasty
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Wroclaw University of Health and Sport Sciences
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score at 4 Weeks
Overview
Brief Summary
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.
Detailed Description
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. Primary outcomes will include changes in psychological distress (stress, anxiety, depressive symptoms; assessed with validated questionnaires) and functional recovery (functional performance and mobility indices), measured at baseline and post-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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals aged 60 years and above who have recently (within the past 3 months) undergone knee or hip joint arthroplasty surgery.
Exclusion Criteria
- •Hearing impairment preventing the use of audio recordings;
- •Cognitive impairment precluding independent completion of study questionnaires;
- •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.
Arms & Interventions
Immersive Virtual Reality Therapy Group
Conventional orthopedic rehabilitation supplemented by VR therapy
Intervention: Immersive Virtual Reality Therapy (Device)
Immersive Virtual Reality Therapy Group
Conventional orthopedic rehabilitation supplemented by VR therapy
Intervention: Conventional rehabilitation (Behavioral)
NSDR Group
Conventional orthopedic rehabilitation supplemented by non-sleep deep rest relaxation
Intervention: Non-Sleep Deep Rest Relaxation (Behavioral)
NSDR Group
Conventional orthopedic rehabilitation supplemented by non-sleep deep rest relaxation
Intervention: Conventional rehabilitation (Behavioral)
Conventional Rehabilitation Group
Conventional orthopedic rehabilitation
Intervention: Conventional rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score at 4 Weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Joanna Szczepańska-Gieracha
Principal Investigator
Wroclaw University of Health and Sport Sciences