Clinical trial NCT02082951: Family Empathic Behaviour Versus Nurse Empathic Behaviour
Official title: Family Empathic Behaviour Versus Nurse Empathic Behaviour: Comparison of Anxiety Symptoms in the Preoperative Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective was to compare the frequency and intensity of symptoms of anxiety in patients of preoperative cardiac surgery who received empathic behaviour from nurse or family or those who received no specific type of empathic behaviour. This is a randomized clinical trial. The sample consisted of 66 patients in preoperative of cardiac surgery, who were divided in three groups: empathic behaviour by nurses, without specific empathic behaviour and by family. Anxiety was assessed at two time points: before and after the intervention. The instrument used was developed and validated, comprising 19 defining characteristics of the nursing diagnosis anxiety. The hypothesis is that the group who received empathic behaviour from nurse or family will reduce the anxiety.

Detailed description: Primary outcome is anxiety. Anxiety was assessed by a nurse using of an instrument developed and validated previous, based on 19 defining characteristics described by NANDA-International for the nursing diagnosis anxiety: verbalization of fear (expressed concern); apprehension, nervousness, tension, restlessness, anxiety, anxious, insomnia, abnormal respiratory rate, increased pulse, dry mouth, increased perspiration, fatigue, cranky; voice / ends trembling, chest / abdominal pain, urinary urgency, nausea, and vomiting.

Patients were evaluated for the presence and absence of these anxiety 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 21, with the higher the score, the greater was the anxiety symptoms presented by the patient.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years;
* Literate;
* Patient who agreed to participate in the study by signing the consent form at least 24 hours prior to surgery.

Exclusion Criteria:

* Patients with a history of surgery;
* Patients in preoperative cardiac transplantation;
* Patients who did not have at least two defining characteristics of the nursing diagnosis anxiety;
* Patients using anxiolytics;
* Smokers and / or patients who drank any amount of alcohol daily.

Primary outcomes:
measure: The primary outcome was Anxiety.
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
name: Cinthia C Assis, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Luiz Antônio Nogueira-Martins, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of SãoPaulo
name: Alba Lucia BL Barros, PhD
role: STUDY_CHAIR
affiliation: Federal University of São Paulo
name: Juliana L Lopes, PhD
role: STUDY_CHAIR
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