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

NCT02156284 | Completed

• 1 other identifier: U111111568736
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Fear; Thoracic Surgery; Nursing Care; Preoperative Care

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Empathic behaviour by nurses

EXPERIMENTAL

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

Behavioral: Empathic behaviour by nurses

Interventions

Empathic behaviour by nurses BEHAVIORAL

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

Empathic behaviour by nurses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04023-061, Brazil

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Juliana S Jurko

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Alba Lucia B L Barros, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

• Juliana L Lopes, PhD

  Federal University of São Paulo

  STUDY CHAIR

• Cinthia C Assis, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 5, 2014
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 6, 2014

Record last verified: 2014-06

Locations

BR (1)