Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
28. juli 2017 oppdatert 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).
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
39
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Milan, Italia, 20148
- Paolo Banfi
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Andre navn:
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Sham-komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Changes in Heart Rate Variability (HRV), before, during and after the treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Samarbeidspartnere
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2016
Primær fullføring (Faktiske)
1. mars 2016
Studiet fullført (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først innsendt
23. februar 2016
Først innsendt som oppfylte QC-kriteriene
29. februar 2016
Først lagt ut (Anslag)
4. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
31. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juli 2017
Sist bekreftet
1. februar 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FDG_COPDRELAX_01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ubestemt
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