Trials / Active Not Recruiting
Active Not RecruitingNCT07386561
Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty
Adjunctive Virtual Reality Therapy Versus Non-Sleep Deep Rest Relaxation During Postoperative Rehabilitation in Older Adults Undergoing Hip or Knee Arthroplasty
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Wroclaw University of Health and Sport Sciences · Academic / Other
- Sex
- All
- Age
- 60 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Immersive Virtual Reality Therapy | 8 sessions of VR therapy over 4 weeks (each of them 20 minutes long). As a virtual reality source, VRTierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation. |
| BEHAVIORAL | Non-Sleep Deep Rest Relaxation | The experimental group will receive eight sessions of audio recording based on the Non-Sleep Deep Rest (NSDR) concept during the 4-week rehabilitation program. Each 20-minute session is conducted in a quiet setting using noisecancelling headphones. The recording guides patients through a structured body scan, directing attention sequentially to specific body regions and prompting active muscle relaxation. Body scanning is combined with mindful breathing to deepen relaxation and attenuate sympathetic nervous system activity. Therapeutic suggestions focus on reframing overload versus relief, letting go versus holding on, and balancing action with awareness. The intervention aims to enhance psychological resilience and support the balance between the sympathetic and parasympathetic parts of the autonomic nervous system. The protocol is non-invasive, safe, and feasible for routine clinical use. |
| BEHAVIORAL | Conventional rehabilitation | Conventional rehabilitation follows standard postoperative protocols after hip or knee arthroplasty. The 4-week program includes five weekly sessions. Gait training is conducted in hospital corridors under physiotherapist supervision, using assistive devices as needed (crutches, walkers). Daily therapy includes 120 minutes of kinesiotherapy (general exercises and gait training), 30 minutes of ergotherapy to improve functional independence, and three individualized physical therapy procedures (laser therapy, magnetic therapy, or electrotherapy) tailored to patient needs. |
Timeline
- Start date
- 2025-11-21
- Primary completion
- 2026-03-15
- Completion
- 2026-06-30
- First posted
- 2026-02-04
- Last updated
- 2026-02-04
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT07386561. Inclusion in this directory is not an endorsement.