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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

Tracking Information
First Submitted Date  ICMJE February 23, 2016
First Posted Date  ICMJE March 4, 2016
Last Update Posted Date July 31, 2017
Study Start Date  ICMJE January 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 29, 2016)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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)
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE A Quick Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Behavioral: Guided Relaxation Technique
    Other Name: Relaxation Therapy
  • Other: Documentary Movie
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Guided Relaxation Technique
  • 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.

    Intervention: Other: Documentary Movie
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2017)
39
Original Estimated Enrollment  ICMJE
 (submitted: February 29, 2016)
30
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02698904
Other Study ID Numbers  ICMJE FDG_COPDRELAX_01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fondazione Don Carlo Gnocchi Onlus
Study Sponsor  ICMJE Fondazione Don Carlo Gnocchi Onlus
Collaborators  ICMJE Catholic University of the Sacred Heart
Investigators  ICMJE Not Provided
PRS Account Fondazione Don Carlo Gnocchi Onlus
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP