Family Empathic Behaviour Versus Nurse Empathic Behaviour

Family Empathic Behaviour Versus Nurse Empathic Behaviour: Comparison of Anxiety Symptoms in the Preoperative Cardiac Surgery Patients

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Empathic behaviour by family.; Behavioral: Empathic behaviour by nurses.

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04023-061
      • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2: empathic behaviour by family.; Considered the empathic behaviour performed by family as a hospital visit with greater than 45 minutes duration, a person with whom the patient had a good relationship, he considered it to be important and welcome. It is emphasized that these families did not have any prior training and after the visit, patients were asked about how the visit had been seeking to detect the presence of any conversations that have been unpleasant for patients and, if present, the patients were excluded from the study.	Behavioral: Empathic behaviour by family.; Considered the empathic behaviour performed by family as a hospital visit with greater than 45 minutes duration, a person with whom the patient had a good relationship, he considered it to be important and welcome. It is emphasized that these families did not have any prior training and after the visit, patients were asked about how the visit had been seeking to detect the presence of any conversations that have been unpleasant for patients and, if present, the patients were excluded from the study.
Experimental: Group 1: empathic behaviour by nurses.; The empathic behaviour in group 1 was performed by a trained nurse.	Behavioral: Empathic behaviour by nurses.; The empathic behaviour in group 1 was performed by a trained nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome was Anxiety.	Anxiety was assessed by a nurse using 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.	Participants were followed for the duration of preoperative period, an expected average of 4 days.

Collaborators and Investigators

• Sponsor: Juliana de Lima Lopes
• Investigators: Principal Investigator: Cinthia C Assis, PhD, Federal University; Study Director: Luiz Antônio Nogueira-Martins, PhD, Federal University of São Paulo; Study Chair: Alba Lucia BL Barros, PhD, Federal University of SãoPaulo; Study Chair: Juliana L Lopes, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimate): March 10, 2014

Study Record Updates

• Last Update Posted (Estimate): March 10, 2014
• Last Update Submitted That Met QC Criteria: March 6, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: UNIFESP23