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

NCT ID: NCT02156284

Last Updated: 2014-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-12-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

Empathic behaviour by nurses

Patients who received empathic behaviour was performed by a trained nurse.

Group Type: EXPERIMENTAL

Empathic behaviour by nurses

Intervention Type: BEHAVIORAL

Control group: patients without specific empathic behaviour

Intervention group: patients who received the empathic behaviour was performed by a trained nurse.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Juliana de Lima Lopes

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliana S Jurko

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Alba Lucia B L Barros, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Juliana L Lopes, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Cinthia C Assis, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

U111111568736

Identifier Type: -

Identifier Source: org_study_id