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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
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07386561
Enrollment
90
Registered
2026-02-04
Start date
2025-11-21
Completion date
2026-06-30
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy, Osteoarthritis, Hip, Osteoarthritis, Knee

Keywords

virtual reality, arthroplasty, psychological outcomes, functional state, anxiety, stress, ortopedic rehabilitation, relaxation

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. 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.

Interventions

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.

BEHAVIORALNon-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.

BEHAVIORALConventional 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.

Sponsors

Wroclaw University of Health and Sport Sciences
Lead SponsorOTHER
Wroclaw Medical University
CollaboratorOTHER
Jan Dlugosz University in Czestochowa
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
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 (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.

Design outcomes

Primary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS) Total Score at 4 WeeksBaseline and 4 weeksThe 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.

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) Score at 4 WeeksBaseline and 4 weeksThe Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) is a 7-item instrument assessing anxiety symptoms in hospital patients. Each item is scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety symptom severity.
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)Baseline and 4 weeksThe Hospital Anxiety and Depression Scale - Depression subscale (HADS-D) is a 7-item instrument assessing depressive symptoms in hospital patients. Each item is scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater depressive symptom severity.
Modified Rivermead Motor Assessment - Gross Function (RMA-GF) Score at 4 WeeksBaseline and 4 weeksThe Gross Function section of the Rivermead Motor Assessment (RMA-GF) evaluates gross motor mobility, including transfers, standing, walking, and stair negotiation. A modified 11-item version was used. The 10-meter running and jumping items from the original 13-item scale were excluded because these activities were not considered appropriate during early rehabilitation following total hip or knee arthroplasty. Each task was scored as completed (1 point) or not completed (0 points), resulting in a total score ranging from 0 to 11. Higher scores indicate better functional mobility.
Short Physical Performance Battery (SPPB) Score at 4 WeeksBaseline and 4 weeksThe Short Physical Performance Battery (SPPB) combines assessments of balance, gait speed, and chair stand tests, with composite scores ranging from 0 (worst) to 12 (best). Higher scores indicate better physical function.
Barthel Index Score at 4 WeeksBaseline and 4 weeksThe Barthel Index assesses independence in activities of daily living (ADL), with scores ranging from 0 to 100. Higher scores represent greater functional independence.
Tinetti's Short Scale Score at 4 WeeksBaseline and 4 weeksTinetti's Short Scale assesses fall risk through evaluation of gait and balance over five tasks. Scores range from 0 to 15, with higher scores indicating better functional mobility.
Visual Analogue Scale (VAS) Score at 4 WeeksBaseline and 4 weeksThe Visual Analogue Scale (VAS) was used to assess current pain intensity. Participants indicated their pain on a 100-mm horizontal line anchored by "no pain" at 0 mm and "worst pain imaginable" at 100 mm. The recorded values were transformed to a 0-10 scale for analysis, with higher scores indicating greater pain intensity.
Perceived Stress Scale (PSS-10) Score at 4 WeeksBaseline and 4 weeksThe 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.
Generalized Self-Efficacy Scale (GSES) Score at 4 WeeksBaseline and 4 weeksThe 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.
Perception of Stress Questionnaire (PSQ) Score at 4 WeeksBaseline and 4 weeksThe 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.
Perception of Stress Questionnaire Emotional Tension Subscale Score at 4 WeeksBaseline and 4 weeksThe Emotional Tension subscale of the Perception of Stress Questionnaire (PSQ) consists of 7 items. Scores range from 7 to 35, with higher scores indicating greater emotional tension.
Perception of Stress Questionnaire External Stress Subscale Score at 4 WeeksBaseline and 4 weeksThe External Stress subscale of the Perception of Stress Questionnaire (PSQ) consists of 7 items. Scores range from 7 to 35, with higher scores indicating greater stress associated with external demands and circumstances.
Perception of Stress Questionnaire Intrapsychic Stress Subscale Score at 4 WeeksBaseline and 4 weeksThe Intrapsychic Stress subscale of the Perception of Stress Questionnaire (PSQ) consists of 7 items. Scores range from 7 to 35, with higher scores indicating greater intrapsychic stress.

Countries

Poland

Contacts

PRINCIPAL_INVESTIGATORJoanna Szczepańska-Gierahca, PhD

Wrocław University of Health and Sport Sciences

PRINCIPAL_INVESTIGATORJustyna Mazurek, PhD

Wroclaw Medical University

PRINCIPAL_INVESTIGATORBłażej Cieślik, PhD

Jan Dlugosz University in Czestochowa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026