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Clinical Trials/NCT04601545
NCT04601545
Completed
Not Applicable

The Evaluation of the Efficiency of Immersive Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method

Wroclaw University of Health and Sport Sciences2 sites in 1 country50 target enrollmentOctober 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease
Sponsor
Wroclaw University of Health and Sport Sciences
Enrollment
50
Locations
2
Primary Endpoint
Hospital Anxiety and Depression Scale (HADS)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study evaluates the effectiveness of virtual reality (VR) therapy in the treatment of depression and anxiety symptoms in patients undergoing the pulmonary rehabilitation. The first study group will receive VR therapy (VR group) as an addition to the traditional pulmonary rehabilitation. The second group (active control group) will receive Schultz Autogenic Training as a standard supplement to the pulmonary treatment. The third group (control group) will undergo only the traditional pulmonary rehabilitation.

Detailed Description

Pulmonary rehabilitation leads to the improvement to the physical capacity and overall fitness of the patients with COPD allowing restoration of independence in daily functioning. Psychological support is required in order to reduce the negative psychological symptoms related to both the pulmonary disease itself and the comorbidities. In this study the investigators want to assess the effectiveness of the virtual reality (VR) therapy compared to standard psychological support (Schultz Autogenic Training). Thanks to using head mounted display (VR goggles 2018) and the phenomenon of total immersion VR therapy allows to completely separate the patient from the hospital environment, provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or, in another part of the therapy, it can motivate the patient to the rehabilitation process. The additional aim of the VR therapy is to help the patients regain their emotional balance, let them recognize their psychological resources and trigger the natural recovery mechanisms. The goals of the project: 1. The evaluation of the influence of VR therapy on the depressive symptoms, the anxiety level and the stress level of the patients undergoing the pulmonary rehabilitation. 2. The comparison of the influence of the VR therapy and Schultz Autogenic Training on the pulmonary rehabilitation process. 3. The evaluation of the pulmonary therapy improvements in patients with and without depressive, anxiety or stress symptoms.

Registry
clinicaltrials.gov
Start Date
October 23, 2020
End Date
November 13, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wroclaw University of Health and Sport Sciences
Responsible Party
Principal Investigator
Principal Investigator

Joanna Szczepańska-Gieracha

Professor

Wroclaw University of Health and Sport Sciences

Eligibility Criteria

Inclusion Criteria

  • Pulmonary rehabilitation conducted in ward settings;
  • anxiety symptoms scored 8 and more in HADS-A or depressive symptoms scored 8 and more in HADS-D.

Exclusion Criteria

  • inability to self-complete the research questionnaires;
  • presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
  • initiation of psychiatric treatment during the research project;
  • contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
  • the patient's refusal at any stage of the research project.

Outcomes

Primary Outcomes

Hospital Anxiety and Depression Scale (HADS)

Time Frame: 15 minutes

The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.

Perception of Stress Questionnaire (PSQ)

Time Frame: 30 minutes

The Perception of Stress Questionnaire (PSQ) is a 27-item scale scoring from 1 to 5 for each item. 21 items examine the level of stress in the area of emotional tension, external stress and intrapsychic stress, and 6 items refer to the lie scale. The global scoring for perception of stress ranges from 21 to 105 with a cut-off point of 60 for high level of perceived stress. The higher the score, the greater the sense of stress. PSQ will be performed at the beginning and after four weeks of treatment.

Secondary Outcomes

  • Spirometry Test(20 minutes)
  • Six-Minute Walk Test (6MWT)(10 minutes)

Study Sites (2)

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