search
Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Guided Relaxation Technique
Documentary Movie
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease (COPD), Relaxation Technique, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Paolo Banfi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Guided Relaxation Technique

Documentary movie

Arm 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.

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.

Outcomes

Primary Outcome Measures

Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)

Secondary Outcome Measures

Changes in Heart Rate Variability (HRV), before, during and after the treatment
Changes in oxygen saturation (SpO2), before, during and after the treatment
Changes in airway resistance (kPa/l/s) before and after the treatment
Changes in subjective feelings of anxiety, before and after the treatment, as measured by the State Trait Anxiety Inventory (STAI-Y1)
Changes in the intensity of subjective feelings, before and after the treatment, as assessed by a Visual Analogue Scale (VAS)
Changes in the intensity of positive and negative affects, before and after the treatment, as assessed by the Positive and Negative Affective Schedule (PANAS)
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)
Differences in Forced Vital Capacity (FVC), before and after the treatment
Differences in Forced Expiratory Volume in The First Second (FEV1), before and after the treatment

Full Information

First Posted
February 23, 2016
Last Updated
July 28, 2017
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Catholic University of the Sacred Heart
search

1. Study Identification

Unique Protocol Identification Number
NCT02698904
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborators
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Relaxation Technique, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided Relaxation Technique
Arm Type
Experimental
Arm 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.
Arm Title
Documentary movie
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Guided Relaxation Technique
Other Intervention Name(s)
Relaxation Therapy
Intervention Type
Other
Intervention Name(s)
Documentary Movie
Primary Outcome Measure Information:
Title
Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)
Time Frame
Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
Secondary Outcome Measure Information:
Title
Changes in Heart Rate Variability (HRV), before, during and after the treatment
Time Frame
It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
Title
Changes in oxygen saturation (SpO2), before, during and after the treatment
Time Frame
It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
Title
Changes in airway resistance (kPa/l/s) before and after the treatment
Time Frame
Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
Title
Changes in subjective feelings of anxiety, before and after the treatment, as measured by the State Trait Anxiety Inventory (STAI-Y1)
Time Frame
Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
Title
Changes in the intensity of subjective feelings, before and after the treatment, as assessed by a Visual Analogue Scale (VAS)
Time Frame
Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
Title
Changes in the intensity of positive and negative affects, before and after the treatment, as assessed by the Positive and Negative Affective Schedule (PANAS)
Time Frame
Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
Title
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
Description
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)
Time Frame
After the session of relaxation training/documentary movie (60-80 minutes after the baseline)
Title
Differences in Forced Vital Capacity (FVC), before and after the treatment
Time Frame
Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
Title
Differences in Forced Expiratory Volume in The First Second (FEV1), before and after the treatment
Time Frame
Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Paolo Banfi
City
Milan
ZIP/Postal Code
20148
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29744054
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs