- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02156284
Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
SP
-
São Paulo, SP, Brasilien, 04023-061
- Federal University of São Paulo
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The primary outcome was Fear.
Tidsram: 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.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Juliana L Lopes, PhD, Federal University of São Paulo
- Huvudutredare: Juliana S Jurko, Federal University of São Paulo
- Studierektor: Alba Lucia B L Barros, PhD, Federal University of São Paulo
- Studiestol: Cinthia C Assis, PhD, Federal University of São Paulo
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- U111111568736
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