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Completed

NCT Number: NCT02698904

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

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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Anxiety Disorders Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paolo Banfi

Milan, 20148, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Relaxation Technique

Behavioral

Other names: Relaxation Therapy

Documentary Movie

Other

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Catholic University of the Sacred Heart

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2016
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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