Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
28 juli 2017 uppdaterad av: Fondazione Don Carlo Gnocchi Onlus
A Quick 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
39
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Milan, Italien, 20148
- Paolo Banfi
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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Andra namn:
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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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)
Tidsram: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Changes in Heart Rate Variability (HRV), before, during and after the treatment
Tidsram: It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Changes in oxygen saturation (SpO2), before, during and after the treatment
Tidsram: It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Changes in airway resistance (kPa/l/s) before and after the treatment
Tidsram: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Changes in subjective feelings of anxiety, before and after the treatment, as measured by the State Trait Anxiety Inventory (STAI-Y1)
Tidsram: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Changes in the intensity of subjective feelings, before and after the treatment, as assessed by a Visual Analogue Scale (VAS)
Tidsram: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Changes in the intensity of positive and negative affects, before and after the treatment, as assessed by the Positive and Negative Affective Schedule (PANAS)
Tidsram: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
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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
Tidsram: After the session of relaxation training/documentary movie (60-80 minutes after the baseline)
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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)
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After the session of relaxation training/documentary movie (60-80 minutes after the baseline)
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Differences in Forced Vital Capacity (FVC), before and after the treatment
Tidsram: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Differences in Forced Expiratory Volume in The First Second (FEV1), before and after the treatment
Tidsram: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
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Samarbetspartners och utredare
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Samarbetspartners
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2016
Primärt slutförande (Faktisk)
1 mars 2016
Avslutad studie (Faktisk)
1 juli 2016
Studieregistreringsdatum
Först inskickad
23 februari 2016
Först inskickad som uppfyllde QC-kriterierna
29 februari 2016
Första postat (Uppskatta)
4 mars 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 juli 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juli 2017
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FDG_COPDRELAX_01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Obeslutsam
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