Pulmonary DiseaseNCT04601545
The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method
A study testing Pulmonary rehabilitation and Virtual therapeutic support in people with Pulmonary Disease and COPD, run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Pulmonary Disease, COPD, Anxiety State
- What is being tested?
- Pulmonary rehabilitation and Virtual therapeutic support
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPoland
- Study dates
- 23 Oct 2020to 13 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Specialist Hospital of the Ministry of Internal Affairs and Administration
Głuchołazy, Opole Voivodeship, 48-340
University School of Physical Education
Wroclaw, Lower Silesian Voivodeship, 51-612
About this study
Official title: The Evaluation of the Efficiency of Immersive Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method
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.
Read the 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.
- Conditions
- Pulmonary Disease, COPD, Anxiety State, Stress, Depressive Symptoms, Mood Disorders
- Being tested
- Pulmonary rehabilitation, Virtual therapeutic support
- Keywords
- virtual reality, pulmonary rehabilitation, psychotherapy, depression, anxiety, stress, COPD
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationBehavioural
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.
Virtual therapeutic supportDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| VR therapy group | Experimental | Pulmonary rehabilitation supplemented by VR therapy Receives: Device: Virtual therapeutic support |
| Active Control Group | Active comparator | Pulmonary rehabilitation supplemented by Schultz Autogenic Training Receives: Behavioral: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
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.
Measured: 30 minutes
Secondary outcomes (2)
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.
Measured: 10 minutes
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start23 Oct 2020
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw University of Health and Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Senior Citizen Activation SIWY DYM
- Responsible party
- Principal investigator, Joanna Szczepańska-Gieracha, Wroclaw University of Health and Sport Sciences
- Investigators
- Sebastian Rutkowski, PhD, Principal investigator, The Opole University of Technology, PolandJoanna Szczepańska- Gieracha, Prof, Study director, University School of Physical Education, PolandJoanna Szczepańska-Gieracha, Prof, Study chair, University School of Physical Education, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601545
- Sponsor's protocol ID
- VR TierOne PR
- Status last verified
- Nov 2020
- First submitted
- 19 Oct 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25419126Coventry 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.
PubMed 23585837Luk 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.
PubMed 28150856da 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.
PubMed 24874610Bhandari 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.
PubMed 23399845
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Efficiency of Immersive Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method
- ClinicalTrials.gov ID
- NCT04601545
- Acronym / sponsor ID
- VR TierOne PR
- Conditions
- Pulmonary Disease, COPD, Anxiety State, Stress, Depressive Symptoms, Mood Disorders
- Keywords
- virtual reality, pulmonary rehabilitation, psychotherapy, depression, anxiety, stress, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Wroclaw University of Health and Sport SciencesUniversity, hospital or other
- Collaborators
- Foundation for Senior Citizen Activation SIWY DYM
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR therapy group | Experimental | Device: Virtual therapeutic supportPulmonary rehabilitation supplemented by VR therapy |
| Active Control Group | Active comparator | Behavioral: Pulmonary rehabilitationPulmonary rehabilitation supplemented by Schultz Autogenic Training |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationThree 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. | Behavioural | Active Control Group |
| Virtual therapeutic support8 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. | Device | VR therapy group |
Primary outcome
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.
2 secondary outcomes
Six-Minute Walk Test (6MWT)
Time frame: 10 minutes
Spirometry Test
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Background: PubMed 25419126Panagioti 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.
- Background: PubMed 23585837Coventry 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.
- Background: PubMed 28150856Luk 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.
- Background: PubMed 24874610da 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.
- Background: PubMed 23399845Bhandari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Rutkowski, PhD principal investigator
The Opole University of Technology, Poland
Joanna Szczepańska- Gieracha, Prof study director
University School of Physical Education, Poland
Joanna Szczepańska-Gieracha, Prof study chair
University School of Physical Education, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation and Virtual therapeutic support in people with Pulmonary Disease and COPD, run by Wroclaw University of Health and Sport Sciences at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04601545, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.