Clinical trial NCT04601545: The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method
Official title: The Evaluation of the Efficiency of Immersive Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
COPD
Anxiety State
Stress
Depressive Symptoms
Mood Disorders
Keywords: virtual reality
pulmonary rehabilitation
psychotherapy
depression
anxiety
stress
COPD
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Foundation for Senior Citizen Activation SIWY DYM
First posted: 2020-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* COPD;
* 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 minutes
measure: Perception of Stress Questionnaire (PSQ)
timeFrame: 30 minutes
Secondary outcomes:
measure: Six-Minute Walk Test (6MWT)
timeFrame: 10 minutes
measure: Spirometry Test
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: University School of Physical Education
state: Dolnoslaskie
city: Glucholazy
country: Poland
facility: Specialist Hospital of the Ministry of Internal Affairs and Administration
state: Opolskie
Study officials:
affiliation: The Opole University of Technology, Poland
name: Sebastian Rutkowski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University School of Physical Education, Poland
name: Joanna Szczepańska- Gieracha, Prof
role: STUDY_DIRECTOR
affiliation: University School of Physical Education, Poland
name: Joanna Szczepańska-Gieracha, Prof
role: STUDY_CHAIR
References:
citation: Panagioti M, Scott C, Blakemore A, Coventry PA. Overview of the prevalence, impact, and management of depression and anxiety in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014 Nov 13;9:1289-306. doi: 10.2147/COPD.S72073. eCollection 2014.
citation: Coventry PA, Bower P, Keyworth C, Kenning C, Knopp J, Garrett C, Hind D, Malpass A, Dickens C. The effect of complex interventions on depression and anxiety in chronic obstructive pulmonary disease: systematic review and meta-analysis. PLoS One. 2013 Apr 5;8(4):e60532. doi: 10.1371/journal.pone.0060532. Print 2013.
citation: Luk EK, Gorelik A, Irving L, Khan F. Effectiveness of cognitive behavioural therapy in a community-based pulmonary rehabilitation programme: A controlled clinical trial. J Rehabil Med. 2017 Mar 6;49(3):264-269. doi: 10.2340/16501977-2189.
citation: da Costa CC, de Azeredo Lermen C, Colombo C, Canterle DB, Machado ML, Kessler A, Teixeira PJ. Effect of a Pulmonary Rehabilitation Program on the levels of anxiety and depression and on the quality of life of patients with chronic obstructive pulmonary disease. Rev Port Pneumol. 2014 Nov-Dec;20(6):299-304. doi: 10.1016/j.rppneu.2014.03.007. Epub 2014 May 27.
citation: Bhandari NJ, Jain T, Marolda C, ZuWallack RL. Comprehensive pulmonary rehabilitation results in clinically meaningful improvements in anxiety and depression in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil Prev. 2013 Mar-Apr;33(2):123-7. doi: 10.1097/HCR.0b013e31828254d4.