- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02698904
Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
A Quick Relaxation Training for People With Chronic Obstructive Pulmonary Disease (COPD)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Milan, Italien, 20148
- Paolo Banfi
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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.
|
Andere Namen:
|
Schein-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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Differences in patients' state of dyspnea, before and after the treatment, as assessed by the Borg Scale (BORG)
Zeitfenster: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
|
Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Changes in Heart Rate Variability (HRV), before, during and after the treatment
Zeitfenster: It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
|
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
Zeitfenster: It is recorded for 5 minutes before, during and after the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
|
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
Zeitfenster: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
|
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)
Zeitfenster: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
|
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)
Zeitfenster: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
|
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)
Zeitfenster: Before the session of relaxation training/documentary movie and after it (60-80 minutes elapsed time)
|
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
Zeitfenster: 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)
|
After the session of relaxation training/documentary movie (60-80 minutes after the baseline)
|
Differences in Forced Vital Capacity (FVC), before and after the treatment
Zeitfenster: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
|
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
Zeitfenster: Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
|
Baseline and following filling in all the psychological tests and the session of relaxation technique/documentary movie (60-80 minutes elapsed time)
|
Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FDG_COPDRELAX_01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Guided Relaxation Technique
-
Massachusetts General HospitalNational Center for Complementary and Integrative Health (NCCIH)AbgeschlossenResilienz, PsychVereinigte Staaten
-
Dana-Farber Cancer InstituteAbgeschlossenMonoklonale Gammopathie unbestimmter Bedeutung | Schwelendes Multiples MyelomVereinigte Staaten
-
University of MontanaAbgeschlossenTraumatischer Stress | Alpträume nach einem TraumaVereinigte Staaten
-
Massachusetts General HospitalBenson-Henry Institute for Mind Body MedicineAbgeschlossenDepression | Lebensqualität | Betonen | Vorhofflimmern | Angst | FeindseligkeitVereinigte Staaten
-
University of TulsaAbgeschlossenAlbträume im Zusammenhang mit Trauma und StressVereinigte Staaten
-
Mohammed RamadanNoch keine RekrutierungEinzelner Zahn verloren | Teilweise zahnloser OberkieferÄgypten
-
NYU Langone HealthAbgeschlossenPosttraumatische Belastungsstörung (PTBS)Vereinigte Staaten
-
Chinese University of Hong KongRekrutierung
-
Chinese University of Hong KongRekrutierung
-
NYU Langone Health7D Surgical Inc.ZurückgezogenSkoliose | Spinale Stenose | Spondylolisthese