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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698904
• Other study ID #: FDG_COPDRELAX_01
• Status: Completed
• Phase: N/A
• First received: February 23, 2016
• Last updated: July 28, 2017
• Start date: January 2016
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Guided Relaxation Technique

Other:
• Documentary Movie

Locations

Country	Name	City	State
Italy	Paolo Banfi	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

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)