- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02156284
Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
SP
-
São Paulo, SP, Brasilien, 04023-061
- Federal University of São Paulo
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Empathic behaviour by nurses
Patients who received empathic behaviour was performed by a trained nurse.
|
Control group: patients without specific empathic behaviour Intervention group: patients who received the empathic behaviour was performed by a trained nurse. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The primary outcome was Fear.
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Juliana L Lopes, PhD, Federal University of São Paulo
- Ledende efterforsker: Juliana S Jurko, Federal University of São Paulo
- Studieleder: Alba Lucia B L Barros, PhD, Federal University of São Paulo
- Studiestol: Cinthia C Assis, PhD, Federal University of São Paulo
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- U111111568736
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Kliniske forsøg med Kardiovaskulær sygdom
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Ottawa Hospital Research InstituteAfsluttetStress | Crisis Resource Management (CRM) færdigheder | Advanced Cardiovascular Life Support (ACLS) færdighederCanada