RecruitingACTRN12626000164392

Assessment of depressive and anxiety in dialysis patients undergoing virtual reality (VR) therapy

Assessment of depressive and anxiety disorders and immunoinflammatory response in patients with end-stage renal disease undergoing virtual reality therapy


Sponsor

Wroclaw University of Health and Sport Sciences

Enrollment

80 participants

Start Date

Jul 1, 2025

Study Type

Interventional

Conditions

Summary

The aim of the project is to assess the impact of relaxation therapies using 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. Hypotheses: Intradialytic VR relaxation therapy will reduce symptoms associated with depression and anxiety in hemodialysis patients and improve perceived self-efficacy. The study group will consist of 80 patients from the hospital dialysis center in Boleslawiec and Wroclaw (Poland). Qualified patients will be randomly divided into two groups: Group I – study group – hemodialysis patients undergoing VR therapy (40 people) Group II – comparison group – hemodialysis patients not participating in VR therapy (40 people). Training will be conducted for 4 weeks, 3 times a week (during hemodialysis treatment), with each session lasting 20 minutes. Relaxation therapy will be conducted using immersive VR goggles. VR therapies are considered acceptable and safe for the patient, with limited adverse effects of VR exposure (nausea, dizziness, malaise).


Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

People with end-stage kidney disease who require regular haemodialysis — a treatment that filters the blood through a machine — often experience high rates of depression and anxiety. These sessions can last three to five hours, three times a week, and the process is both physically and emotionally taxing. This study is testing whether using virtual reality (VR) goggles during dialysis sessions — watching calming, immersive environments — can reduce depression and anxiety in these patients. Participants will be randomly assigned to either receive 20-minute VR relaxation sessions three times per week for four weeks during their dialysis treatment, or to continue dialysis as usual without VR. Researchers will measure depression and anxiety levels, perceived self-efficacy, inflammation markers, and physical function before and after the four-week program. You may be eligible if you are aged 40 to 70, have chronic kidney disease, and have been on haemodialysis for at least three months. People with epilepsy, severe vertigo, motion sickness, untreated depression, or dementia would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 perfo

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.


Locations(1)

Wroclaw, Boleslawiec, Poland

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ACTRN12626000164392