Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Behavioral: Empathic behaviour by nurses

• Registration Number: NCT02156284
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-03
• Last Update Submitted: 2014-06-04
• Study First Posted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Empathic behaviour by nurses	Empathic behaviour by nurses	Patients who received empathic behaviour was performed by a trained nurse.

Primary Outcome Measures

Name	Time	Method
The primary outcome was Fear.	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.

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, SP, Brazil