Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000164392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
3/12/2025
Date registered
Help: Date registered
10/02/2026
Date last updated
Help: Date last updated
10/02/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/02/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of depressive and anxiety in dialysis patients undergoing virtual reality (VR) therapy
Scientific title
Assessment of depressive and anxiety disorders and immunoinflammatory response in patients with end-stage renal disease undergoing virtual reality therapy
Additional trial identifiers [1] 316085 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
end stage renal diseases 339964 0
Condition category
Condition code
Physical Medicine / Rehabilitation 336183 336183 0 0
Physiotherapy
Mental Health 336189 336189 0 0
Depression
Mental Health 336190 336190 0 0
Anxiety
Renal and Urogenital 336191 336191 0 0
Kidney disease
Inflammatory and Immune System 336192 336192 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The aim of the project is to assess the impact of relaxation therapies using virtual reality (VR) on the level of depressive and anxiety disorders in relation to inflammation, circulatory system performance and muscle condition in patients with end-stage renal disease. The study group will consist of 80 patients from the hospital dialysis center in Wroclaw and Boleslawiec, Poland.
All participants were recruited for participation in the program by a nephrologist and a psychologist, who administered Mini Mental State Examination (MMSE) to assess the cognitive status of patients.
Study Procedure:
All participants will be selected for participation in the program by a nephrologist and a psychologist (MMSE scale). Written consent will be obtained from patients to participate in the study, which will be preceded by an explanation of the purpose and procedure of the study, assurance of confidentiality of the collected data, and information about the voluntary nature of participation and the possibility of withdrawal at any time.
Selected patients will be randomly divided into two groups:
Group I – study group – hemodialysis patients undergoing VR therapy (40 participants)
Group II – comparator group – hemodialysis patients not participating in VR therapy (40 participants).
Training will be conducted over a period of 4 weeks, 3 times per week (during hemodialysis treatment), with each session lasting 20 minutes.
The cognitive, emotional and functional state of dialysis patients will be assessed twice (before and after completing VR therapy).
A complete blood count (CBC) with a differential blood count (DBC) will be performed to measure stress levels and inflammation. Blood sampling will be performed as part of a routine dialysis patient assessment.
Blood will be collected twice from the antecubital vein (2 x 8 mL) before the start of VR training (pre-dialysis) and after one month of VR training (maximum 14 sessions) at the hospitals dialysis centers in Wroclaw and Boleslawiec.
Inflammatory classifiers such as NLR (neutrophil-to-lymphocyte ratio), SII (systemic immune inflammation index) and SIRI (systemic inflammation response index) will be calculated based on blood counts and compared to the reference values proposed by Luo et al. All procedures performed as part of the study will be performed by professional, qualified specialists with extensive clinical and research experience, using the most modern equipment available and evidence-based practice and skills.
Relaxation therapy will be conducted using immersive VR goggles (Meta Quest3, USA). VR therapies are considered acceptable and safe for the patient, with limited adverse effects of VR exposure (nausea, dizziness, malaise).
Strategies used to monitor adherence to the intervention - supervision by research staff.
Patients were also informed that VR therapy could be discontinued if adverse reactions occurred (e.g., nausea, dizziness, visual discomfort).
At the beginning of the intervention, a short interview was conducted with each patient to explain and introduce the patient to the technical aspects of using VR goggles and safety rules. During the passive VR therapy, various realistic scenarios were presented, including selected 360° videos and standard 2D landscape videos with relaxation music.
Active, full-immersive applications, requiring the operation of controllers, were excluded for safety reasons. After every session, a short form interview was conducted to assess any adverse reactions. There were no resignations noted due to the adverse reactions to VR therapy.
Intervention code [1] 332695 0
Rehabilitation
Description of the comparator or control
Group II – comparator group – hemodialysis patients not participating in VR therapy (40 participants).
Patients in this comparator group can't engage in other distraction or mindfulness therapies.
Control group
Active

Outcomes
Primary outcome [1] 343735 0
Depression
Timepoint [1] 343735 0
Baseline and one month post-commencement of intervention
Primary outcome [2] 343736 0
Anxiety
Timepoint [2] 343736 0
Baseline and one month post-commencement of intervention
Secondary outcome [1] 455436 0
perceived self-efficacy
Timepoint [1] 455436 0
Baseline and one month post-commencement of intervention
Secondary outcome [2] 455437 0
life satisfaction
Timepoint [2] 455437 0
Baseline and one month post-commencement of intervention
Secondary outcome [3] 455438 0
quality of life
Timepoint [3] 455438 0
Baseline and one month post-commencement of intervention
Secondary outcome [4] 455439 0
Level of illness acceptance
Timepoint [4] 455439 0
Baseline and one month post-commencement of intervention
Secondary outcome [5] 455440 0
balance
Timepoint [5] 455440 0
Baseline and one month post-commencement of intervention
Secondary outcome [6] 455441 0
muscle elastoplastic properties
Timepoint [6] 455441 0
Baseline and one month post-commencement of intervention
Secondary outcome [7] 455442 0
the range and dynamics of body temperature
Timepoint [7] 455442 0
Baseline and one month post-commencement of intervention
Secondary outcome [8] 455443 0
Handgrip strength
Timepoint [8] 455443 0
Baseline and one month post-commencement of intervention
Secondary outcome [9] 455444 0
stress levels and inflammation
Timepoint [9] 455444 0
Baseline and one month post-commencement of intervention
Secondary outcome [10] 455445 0
Inflammatory classifiers: NLR (neutrophil-to-lymphocyte ratio)
Timepoint [10] 455445 0
Baseline and one month post-commencement of intervention
Secondary outcome [11] 456735 0
perceived self-efficacy
Timepoint [11] 456735 0
Baseline and one month post-commencement of intervention
Secondary outcome [12] 456736 0
mood and level of illness acceptance
Timepoint [12] 456736 0
Baseline and one month post-commencement of intervention
Secondary outcome [13] 456737 0
Biochemical testing: a complete blood count (CBC) with a differential blood count (DBC)
Timepoint [13] 456737 0
Baseline and one month post-commencement of intervention
Secondary outcome [14] 456738 0
Biochemical testing: a complete blood count (CBC) with a differential blood count (DBC)
Timepoint [14] 456738 0
Baseline and one month post-commencement of intervention
Secondary outcome [15] 456739 0
muscle elastoplastic properties
Timepoint [15] 456739 0
Baseline and one month post-commencement of intervention
Secondary outcome [16] 456740 0
assessment of physical activity
Timepoint [16] 456740 0
Baseline and one month post-commencement of intervention
Secondary outcome [17] 456741 0
assessment of physical activity
Timepoint [17] 456741 0
Baseline and one month post-commencement of intervention

Eligibility
Key inclusion criteria
• consent to participate in the study,
• diagnosed chronic renal failure (CKD),
• hemodialysis treatment for at least 3 months prior to the start of the study,
• adequate dialysis therapy: dialysis adequacy index Kt/V >1.2; protein catabolism coefficient (PCR) 0.8–1.4 g protein/kg body weight/day,
• ability to perform a full cognitive function test,
• satisfactory cognitive function (MMSE > 23) enabling reliable psychological testing,
• age 40–70 years.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• contraindications to VR training (epilepsy, vertigo, labyrinth disorders, motion sickness),
• presence of serious mental disorders in medical records (e.g., impaired consciousness, dementia),
• adherence to training units below 70%,
• medication-treated depressive disorders or other mental disorders,
• use of other non-pharmacological forms of support during the project,
• lack of consent to participate in the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2025
Date of last participant enrolment
Anticipated
1/07/2026
Actual
Date of last data collection
Anticipated
30/09/2026
Actual
Sample size
Target
80
Accrual to date
22
Final
Recruitment outside Australia
Country [1] 27654 0
Poland
State/province [1] 27654 0
Wroclaw, Boleslawiec

Funding & Sponsors
Funding source category [1] 320681 0
University
Name [1] 320681 0
Wroclaw University of Health and Sport Sciences
Country [1] 320681 0
Poland
Primary sponsor type
University
Name
Wroclaw University of Health and Sport Sciences
Address
Country
Poland
Secondary sponsor category [1] 323321 0
None
Name [1] 323321 0
Address [1] 323321 0
Country [1] 323321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319223 0
Wroclaw University of Health and Sport Sciences Ethic Commitee
Ethics committee address [1] 319223 0
Ethics committee country [1] 319223 0
Poland
Date submitted for ethics approval [1] 319223 0
04/04/2024
Approval date [1] 319223 0
29/05/2024
Ethics approval number [1] 319223 0
9/2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 146662 0
Prof Wioletta Dziubek-Rogowska
Address 146662 0
WROCLAW UNIVERSITY OF HEALTH AND SPORT SCIENCES; al. I.J. Paderewskiego 35; 51-612 Wroclaw; Poland
Country 146662 0
Poland
Phone 146662 0
+48504032148
Fax 146662 0
Email 146662 0
[email protected]
Contact person for public queries
Name 146663 0
Wioletta Dziubek-Rogowska
Address 146663 0
WROCLAW UNIVERSITY OF HEALTH AND SPORT SCIENCES; al. I.J. Paderewskiego 35; 51-612 Wroclaw; Poland
Country 146663 0
Poland
Phone 146663 0
+48504032148
Fax 146663 0
Email 146663 0
[email protected]
Contact person for scientific queries
Name 146664 0
Lukasz Rogowski
Address 146664 0
The Witelon Collegium State University; ul. Sejmowa 5C; 59-220 Legnica; Poland
Country 146664 0
Poland
Phone 146664 0
+48713473522
Fax 146664 0
Email 146664 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    W. Dziubek-Rogowska - Uchwala Komisji ds. Etyki Badan´ Naukowych AWF Wroclaw.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.