Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Relaxation Technique, Anxiety
Brief summary
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).
Interventions
BEHAVIORALGuided Relaxation Technique
OTHERDocumentary Movie
Sponsors
Catholic University of the Sacred Heart
Fondazione Don Carlo Gnocchi Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| 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) | — |
| 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) | — |
| 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) | — |
| 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 | After the session of relaxation training/documentary movie (60-80 minutes after the baseline) | 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) |
| 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) | — |
| 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) | — |
| 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) | — |
Countries
Italy
Outcome results
None listed