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

July 30, 2026 updated by: Joanna Szczepańska-Gieracha, Wroclaw University of Health and Sport Sciences

Adjunctive Virtual Reality Therapy Versus Non-Sleep Deep Rest Relaxation During Postoperative Rehabilitation in Older Adults Undergoing Hip or Knee Arthroplasty

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lower Silesian Voivodeship
      • Trzebnica, Lower Silesian Voivodeship, Poland, 55-100
        • St. Hedwig of Silesia Hospital in Trzebnica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immersive Virtual Reality Therapy Group
Conventional orthopedic rehabilitation supplemented by VR therapy
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: 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.
Experimental: NSDR Group
Conventional orthopedic rehabilitation supplemented by non-sleep deep rest relaxation
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.
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.
Active Comparator: Conventional Rehabilitation Group
Conventional orthopedic rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS) Total 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.
Baseline and 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A) Score at 4 Weeks
Time Frame: Baseline and 4 weeks
The 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.
Baseline and 4 weeks
Hospital Anxiety and Depression Scale - Depression subscale (HADS-D)
Time Frame: Baseline and 4 weeks
The 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.
Baseline and 4 weeks
Modified Rivermead Motor Assessment - Gross Function (RMA-GF) Score at 4 Weeks
Time Frame: Baseline and 4 weeks
The 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.
Baseline and 4 weeks
Short Physical Performance Battery (SPPB) Score at 4 Weeks
Time Frame: Baseline and 4 weeks
The 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.
Baseline and 4 weeks
Barthel Index Score at 4 Weeks
Time Frame: Baseline and 4 weeks
The Barthel Index assesses independence in activities of daily living (ADL), with scores ranging from 0 to 100. Higher scores represent greater functional independence.
Baseline and 4 weeks
Tinetti's Short Scale Score at 4 Weeks
Time Frame: Baseline and 4 weeks
Tinetti'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.
Baseline and 4 weeks
Visual Analogue Scale (VAS) Score at 4 Weeks
Time Frame: Baseline and 4 weeks
The 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.
Baseline and 4 weeks
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks
Perception of Stress Questionnaire Emotional Tension Subscale Score at 4 Weeks
Time Frame: Baseline and 4 weeks
The 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.
Baseline and 4 weeks
Perception of Stress Questionnaire External Stress Subscale Score at 4 Weeks
Time Frame: Baseline and 4 weeks
The 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.
Baseline and 4 weeks
Perception of Stress Questionnaire Intrapsychic Stress Subscale Score at 4 Weeks
Time Frame: Baseline and 4 weeks
The 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.
Baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wroclaw University of Health and Sport Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wroclaw Medical University
Jan Dlugosz University in Czestochowa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Justyna Mazurek, PhD, Wroclaw Medical University
  • Principal Investigator: Joanna Szczepańska-Gierahca, PhD, Wrocław University of Health and Sport Sciences
  • Principal Investigator: Błażej Cieślik, PhD, Jan Dlugosz University in Czestochowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KE-U/108/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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