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The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method

Primary Purpose

Pulmonary Disease, COPD, Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Virtual therapeutic support
Sponsored by
Wroclaw University of Health and Sport Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease focused on measuring virtual reality, pulmonary rehabilitation, psychotherapy, depression, anxiety, stress, COPD

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University School of Physical Education
  • Specialist Hospital of the Ministry of Internal Affairs and Administration

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR therapy group

Active Control Group

Arm Description

Pulmonary rehabilitation supplemented by VR therapy

Pulmonary rehabilitation supplemented by Schultz Autogenic Training

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)
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)
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 Outcome Measures

Six-Minute Walk Test (6MWT)
The six-minute walk test measures the distance a patient is able to walk over a total of six minutes on a firm, flat surface. The aim is for the patient to walk as far as possible in six minutes. The patient is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Spirometry Test
The Forced expiratory volume for 1 second (FEV1%pred.) will be analysed as part of the lung function test. The patient is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible, preferably at least 6 seconds. It is sometimes directly followed by a rapid inhalation, in particular when assessing possible upper airway obstruction. The predicted values will be calculated based on age, weight, and height.

Full Information

First Posted
October 19, 2020
Last Updated
November 13, 2020
Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM
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1. Study Identification

Unique Protocol Identification Number
NCT04601545
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2020 (Actual)
Primary Completion Date
November 13, 2020 (Actual)
Study Completion Date
November 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw University of Health and Sport Sciences
Collaborators
Foundation for Senior Citizen Activation SIWY DYM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. The comparison of the influence of the VR therapy and Schultz Autogenic Training on the pulmonary rehabilitation process. The evaluation of the pulmonary therapy improvements in patients with and without depressive, anxiety or stress symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, COPD, Anxiety State, Stress, Depressive Symptoms, Mood Disorders
Keywords
virtual reality, pulmonary rehabilitation, psychotherapy, depression, anxiety, stress, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR therapy group
Arm Type
Experimental
Arm Description
Pulmonary rehabilitation supplemented by VR therapy
Arm Title
Active Control Group
Arm Type
Active Comparator
Arm Description
Pulmonary rehabilitation supplemented by Schultz Autogenic Training
Intervention Type
Behavioral
Intervention Name(s)
Pulmonary rehabilitation
Intervention Description
Three weeks of pulmonary rehabilitation conducted in an outpatient care facility: 5- time a week for 30 minutes a specific respiratory exercises- relaxation exercises for breathing muscles, exercises to increase breathing, prolonged exhalation exercise, chest percussion 5- time a week for 20-30 min training on a cycle ergometer - until the Heart Rate reaches 60% of the HRmax 5- time a week for 30 minutes a fitness and respiratory exercises - coordination and balance exercises, stretching exercises relaxation by Schultz Autogenic Training. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation.
Intervention Type
Device
Intervention Name(s)
Virtual therapeutic support
Intervention Description
8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR Tier One 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. By performing tasks in the virtual garden, the patient becomes an active participant of the therapeutic process and sees the effects his/her work.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
15 minutes
Title
Perception of Stress Questionnaire (PSQ)
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Six-Minute Walk Test (6MWT)
Description
The six-minute walk test measures the distance a patient is able to walk over a total of six minutes on a firm, flat surface. The aim is for the patient to walk as far as possible in six minutes. The patient is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time Frame
10 minutes
Title
Spirometry Test
Description
The Forced expiratory volume for 1 second (FEV1%pred.) will be analysed as part of the lung function test. The patient is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible, preferably at least 6 seconds. It is sometimes directly followed by a rapid inhalation, in particular when assessing possible upper airway obstruction. The predicted values will be calculated based on age, weight, and height.
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Rutkowski, PhD
Organizational Affiliation
The Opole University of Technology, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska- Gieracha, Prof
Organizational Affiliation
University School of Physical Education, Poland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska-Gieracha, Prof
Organizational Affiliation
University School of Physical Education, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
University School of Physical Education
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
51-612
Country
Poland
Facility Name
Specialist Hospital of the Ministry of Internal Affairs and Administration
City
Glucholazy
State/Province
Opolskie
ZIP/Postal Code
48-340
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25419126
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.
Results Reference
background
PubMed Identifier
23585837
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.
Results Reference
background
PubMed Identifier
28150856
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.
Results Reference
background
PubMed Identifier
24874610
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.
Results Reference
background
PubMed Identifier
23399845
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.
Results Reference
background

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The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method

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