Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: Documentary Movie; Behavioral: Guided Relaxation Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02698904

FDG_COPDRELAX_01

Details and patient eligibility

About

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).

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups

Guided Relaxation Technique

Experimental group

Description:

Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC, Heart Rate Variability (HRV), airway resistance (kPa/l/s), before and after an 11 minutes, one-session, guided relaxation technique Following 30-40 minutes questionnaire, 5 minutes heart rate (HR) and oxygen saturation (SpO2) recording, 11 minutes relaxation technique (listening via headphone to audio recording. In the meanwhile, heart rate and saturation are recording) to be completed by second heart rate (HR) and oxygen saturation (SpO2) recording. Entire procedure 60-80 minutes.

Treatment:

Behavioral: Guided Relaxation Technique

Documentary movie

Sham Comparator group

Description:

Forced Vital Capacity (FVC), Forced Expiratory Volume in the First Second (FEV1), FEV1/FVC, Heart Rate Variability (HRV), airway resistance (kPa/l/s), before and after an 11 minutes documentary movie. Following 30-40 minutes questionnaire, 5 minutes heart rate (HR) and oxygen saturation (SpO2) recording, 11 minutes documentary movie (listening via headphone. In the meanwhile, heart rate and saturation are recording) to be completed by second heart rate (HR) and oxygen saturation (SpO2) recording. Entire procedure 60-80 minutes.

Treatment:

Other: Documentary Movie