Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Quick Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
Verified date | February 2016 |
Source | Fondazione Don Carlo Gnocchi Onlus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
People with Chronic Obstructive Pulmonary Disease (COPD) suffer from dyspnoea, which may be exacerbated by psychological outcomes including anxiety and depression. Previous studies suggest that relaxation techniques may have positive effects on pulmonary rehabilitation. The main aim of this study is to explore both the respiratory and psychological impact of a quick, one-session, relaxation training for people with Chronic Obstructive Pulmonary Disease (COPD).
Status | Completed |
Enrollment | 39 |
Est. completion date | July 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Written Informed Consent; - Chronic Obstructive Pulmonary Disease (COPD) diagnosis confirmed by a specialized physician; - basal FEV1/FVC <70%, using the standards established by Global Initiative For Chronic Obstructive Lung Disease (GOLD); - Modified British Medical Research Council Questionnaire (mMRC) = 2; - COPD Assessment Test (CAT) = 10. Exclusion Criteria: - Pregnancy; - psychiatric disturbances; - oncological diseases; - comorbid states that determine an immunosuppressive condition. |
Country | Name | City | State |
---|---|---|---|
Italy | Paolo Banfi | Milan |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus | Catholic University of the Sacred Heart |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG) | Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time) | ||
Secondary | Changes in Heart Rate Variability (HRV), before, during and after the treatment | It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time) | ||
Secondary | Changes in oxygen saturation (SpO2), before, during and after the treatment | It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time) | ||
Secondary | Changes in airway resistance (kPa/l/s) before and after the treatment | Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time) | ||
Secondary | Changes in subjective feelings of anxiety, before and after the treatment, as measured by the State Trait Anxiety Inventory (STAI-Y1) | Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time) | ||
Secondary | Changes in the intensity of subjective feelings, before and after the treatment, as assessed by a Visual Analogue Scale (VAS) | Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time) | ||
Secondary | Changes in the intensity of positive and negative affects, before and after the treatment, as assessed by the Positive and Negative Affective Schedule (PANAS) | Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time) | ||
Secondary | Presence and intensity of the possible subjective experience of engaging just-manageable challenges by tackling a series of goals, continuously processing feedback about progress, and adjusting action based on this feedback, after the treatment | Presence and intensity of the possible state of flow experience, as assessed by a short form of the Flow State Scale, called Short Flow State Scale -2 (FSS-2) | After the session of relaxation training/documentary movie (60-80 minutes after the baseline) | |
Secondary | Differences in Forced Vital Capacity (FVC), before and after the treatment | Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time) | ||
Secondary | Differences in Forced Expiratory Volume in The First Second (FEV1), before and after the treatment | Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time) |
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