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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156284
• Other study ID #: U111111568736
• Status: Completed
• Phase: N/A
• First received: June 3, 2014
• Last updated: June 4, 2014
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Empathic behaviour by nurses
Control group: patients without specific empathic behaviour Intervention group: patients who received the empathic behaviour was performed by a trained nurse.

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was Fear.	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.	No