Clinical trial NCT02698904: Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Quick Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Relaxation Technique
Anxiety
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2016-03-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)
timeFrame: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
Secondary outcomes:
measure: Changes in Heart Rate Variability (HRV), before, during and after the treatment
timeFrame: It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
measure: Changes in oxygen saturation (SpO2), before, during and after the treatment
timeFrame: It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
measure: Changes in airway resistance (kPa/l/s) before and after the treatment
timeFrame: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
measure: Changes in subjective feelings of anxiety, before and after the treatment, as measured by the State Trait Anxiety Inventory (STAI-Y1)
timeFrame: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
measure: Changes in the intensity of subjective feelings, before and after the treatment, as assessed by a Visual Analogue Scale (VAS)
timeFrame: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
measure: Changes in the intensity of positive and negative affects, before and after the treatment, as assessed by the Positive and Negative Affective Schedule (PANAS)
timeFrame: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
measure: 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
timeFrame: After the session of relaxation training/documentary movie (60-80 minutes after the baseline)
measure: Differences in Forced Vital Capacity (FVC), before and after the treatment
timeFrame: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
measure: Differences in Forced Expiratory Volume in The First Second (FEV1), before and after the treatment
timeFrame: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Paolo Banfi
Study officials:
References:
citation: Volpato E, Banfi P, Nicolini A, Pagnini F. A quick relaxation exercise for people with chronic obstructive pulmonary disease: explorative randomized controlled trial. Multidiscip Respir Med. 2018 May 2;13:13. doi: 10.1186/s40248-018-0124-9. eCollection 2018.