The Virtual Reality Therapy as a Pulmonary Rehabilitation Supporting Method

NCT04601545 | Completed

• 1 other identifier: VR TierOne PR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Disease; COPD; Anxiety State; Stress; Depressive Symptoms; Mood Disorders

Keywords

virtual reality; pulmonary rehabilitation; psychotherapy; depression; anxiety; stress; COPD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 minutes

Secondary Outcomes (2)

• Six-Minute Walk Test (6MWT)

  10 minutes

• Spirometry Test

  20 minutes

Study Arms (2)

VR therapy group

EXPERIMENTAL

Pulmonary rehabilitation supplemented by VR therapy

Device: Virtual therapeutic support

Active Control Group

ACTIVE COMPARATOR

Pulmonary rehabilitation supplemented by Schultz Autogenic Training

Behavioral: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation BEHAVIORAL

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.

Active Control Group

Virtual therapeutic support DEVICE

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.

VR therapy group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Foundation for Senior Citizen Activation SIWY DYM: collaborator

Study Sites (2)

University School of Physical Education

Wroclaw, Lower Silesian Voivodeship, 51-612, Poland

Location

Specialist Hospital of the Ministry of Internal Affairs and Administration

Głuchołazy, Opole Voivodeship, 48-340, Poland

Location

Related Publications (5)

• 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.

  PMID: 25419126 BACKGROUND

• 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.

  PMID: 23585837 BACKGROUND

• 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.

  PMID: 28150856 BACKGROUND

• 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.

  PMID: 24874610 BACKGROUND

• 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.

  PMID: 23399845 BACKGROUND

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Depression; Mood Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sebastian Rutkowski, PhD

  The Opole University of Technology, Poland

  PRINCIPAL INVESTIGATOR

• Joanna Szczepańska- Gieracha, Prof

  University School of Physical Education, Poland

  STUDY DIRECTOR

• Joanna Szczepańska-Gieracha, Prof

  University School of Physical Education, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: October 23, 2020
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)