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

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ClinicalTrials.gov Identifier: NCT02698904
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
Fondazione Don Carlo Gnocchi Onlus

Study Description
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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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Guided Relaxation Technique Other: Documentary Movie Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Quick Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Guided Relaxation Technique
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.
 Behavioral: Guided Relaxation Technique
Other Name: Relaxation Therapy
Sham Comparator: Documentary movie

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.

 Other: Documentary Movie


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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 [ Time Frame: 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)

  8. 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) ]
  9. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698904


Locations
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Italy
Paolo Banfi
Milan, Italy, 20148
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Catholic University of the Sacred Heart
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT02698904    
Other Study ID Numbers: FDG_COPDRELAX_01
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Fondazione Don Carlo Gnocchi Onlus:
Chronic Obstructive Pulmonary Disease (COPD)
Relaxation Technique
Anxiety
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases