Clinical trial NCT02156284: Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery
Official title: Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Fear; Thoracic Surgery; Nursing Care; Preoperative Care
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The objective was to compare the frequency and intensity of symptoms of fear in patients of preoperative cardiac surgery who received empathic behaviour from nurse or those who received no specific type of empathic behaviour. This is a randomized clinical trial. The sample consisted of 44 patients in preoperative of cardiac surgery, who were divided in two groups: empathic behaviour by nurses and without specific empathic behaviour. Fear was assessed at two time points: before and after the intervention. The instrument used was developed and validated, comprising 15 defining characteristics of the nursing diagnosis fear. The hypothesis is that the group who received empathic behaviour from nurse will reduce the anxiety.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome was Fear.
timeFrame: Participants were followed for the duration of preoperative period, an expected average of 4 days.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Juliana S Jurko
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Alba Lucia B L Barros, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Juliana L Lopes, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Cinthia C Assis, PhD
role: STUDY_CHAIR
References: