Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty

NCT07386561 | Active Not Recruiting

• 1 other identifier: KE-U/108/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy; Osteoarthritis, Hip; Osteoarthritis, Knee

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score at 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.

  Baseline and 4 weeks

• Change from Baseline in Perceived Stress Scale (PSS-10) Score at 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.

  Baseline and 4 weeks

• Change from Baseline in Generalized Self-Efficacy Scale (GSES) Score at 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.

  Baseline and 4 weeks

• Change from Baseline in Perception of Stress Questionnaire (PSQ) Score at 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.

  Baseline and 4 weeks

Secondary Outcomes (5)

• 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

Study Arms (3)

Immersive Virtual Reality Therapy Group

EXPERIMENTAL

Conventional orthopedic rehabilitation supplemented by VR therapy

Device: Immersive Virtual Reality Therapy; Behavioral: Conventional rehabilitation

NSDR Group

EXPERIMENTAL

Conventional orthopedic rehabilitation supplemented by non-sleep deep rest relaxation

Behavioral: Non-Sleep Deep Rest Relaxation; Behavioral: Conventional rehabilitation

Conventional Rehabilitation Group

ACTIVE COMPARATOR

Conventional orthopedic rehabilitation

Behavioral: Conventional rehabilitation

Interventions

Immersive Virtual Reality Therapy DEVICE

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.

Immersive Virtual Reality Therapy Group

Non-Sleep Deep Rest Relaxation BEHAVIORAL

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.

NSDR Group

Conventional rehabilitation BEHAVIORAL

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.

Conventional Rehabilitation Group; Immersive Virtual Reality Therapy Group; NSDR Group

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 60 years and above who have recently (within the past 3 months) undergone knee or hip joint arthroplasty surgery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Wroclaw Medical University: collaborator
• Jan Dlugosz University in Czestochowa: collaborator

Study Sites (1)

St. Hedwig of Silesia Hospital in Trzebnica

Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis, Hip; Osteoarthritis, Knee; Anxiety Disorders

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Osteoarthritis; Arthritis; Rheumatic Diseases; Mental Disorders

Study Officials

• Joanna Szczepańska-Gierahca, PhD

  Wrocław University of Health and Sport Sciences

  PRINCIPAL INVESTIGATOR

• Justyna Mazurek, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

• Błażej Cieślik, PhD

  Jan Dlugosz University in Czestochowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 4, 2026
• Study Start: November 21, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)