- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02156284
Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Primary outcome is fear. Fear was assessed by a nurse using of an instrument developed and validated previous, based on 15 defining characteristics described by North American Nursing Diagnosis Association for the nursing diagnosis fear: apprehension, increased tension, exciting, nervousness, verbalization of fear (expressed concern), increased pulse, nausea, vomiting, fatigue, abnormal respiratory rate, increased perspiration, dry mouth, fear of death (reported), crying and impaired bowel motility.
Patients were evaluated for the presence and absence of these fear symptoms through scores: 0 (no symptom) and 1 (presence of symptom). For analysis of the results was carried out the sum of the scores of each symptom, ranging from 0 to 15, with the higher the score, the greater was the fear symptoms presented by the patient.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
SP
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São Paulo, SP, Brasilien, 04023-061
- Federal University of São Paulo
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients older than 18 years
- Patient who agreed to participate in the study by signing the consent form at least 24 hours prior to surgery
Exclusion Criteria:
- Patients in preoperative cardiac transplantation
- Patients who did not have at least two defining characteristics of the nursing diagnosis fear
- Patients using anxiolytics
- Smokers and / or patients who drank any amount of alcohol daily
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Empathic behaviour by nurses
Patients who received empathic behaviour was performed by a trained nurse.
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Control group: patients without specific empathic behaviour Intervention group: patients who received the empathic behaviour was performed by a trained nurse. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The primary outcome was Fear.
Zeitfenster: Participants were followed for the duration of preoperative period, an expected average of 4 days.
|
Fear was assessed by a nurse using an instrument developed and validated previous, based on 15 defining characteristics described by North American Nursing Diagnosis Association for the nursing diagnosis fear: apprehension, increased tension, exciting, nervousness, verbalization of fear (expressed concern), increased pulse, nausea, vomiting, fatigue, abnormal respiratory rate, increased perspiration, dry mouth, fear of death (reported), crying and impaired bowel motility. Patients were evaluated for the presence and absence of these fear symptoms through scores: 0 (no symptom) and 1 (presence of symptom). For analysis of the results was carried out the sum of the scores of each symptom, ranging from 0 to 15, with the higher the score, the greater was the fear symptoms presented by the patient. |
Participants were followed for the duration of preoperative period, an expected average of 4 days.
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Juliana L Lopes, PhD, Federal University of São Paulo
- Hauptermittler: Juliana S Jurko, Federal University of São Paulo
- Studienleiter: Alba Lucia B L Barros, PhD, Federal University of São Paulo
- Studienstuhl: Cinthia C Assis, PhD, Federal University of São Paulo
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 (Schätzen)
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
- U111111568736
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