Family Empathic Behaviour Versus Nurse Empathic Behaviour

NCT02082951 | Completed DMC

• 1 other identifier: UNIFESP23
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group 2: empathic behaviour by family.

EXPERIMENTAL

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.

Group 1: empathic behaviour by nurses.

EXPERIMENTAL

The empathic behaviour in group 1 was performed by a trained nurse.

Behavioral: Empathic behaviour by nurses.

Interventions

Empathic behaviour by nurses. BEHAVIORAL

The empathic behaviour in group 1 was performed by a trained nurse.

Group 1: empathic behaviour by nurses.

Empathic behaviour by family. BEHAVIORAL

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.

Group 2: empathic behaviour by family.

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;
• Literate;
• 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 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.

Sponsors & Collaborators

• Juliana de Lima Lopes: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04023-061, Brazil

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Cinthia C Assis, PhD

  Federal University

  PRINCIPAL INVESTIGATOR

• Luiz Antônio Nogueira-Martins, PhD

  Federal University of São Paulo

  STUDY DIRECTOR

• Alba Lucia BL Barros, PhD

  Federal University of SãoPaulo

  STUDY CHAIR

• Juliana L Lopes, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Juliana de Lima Lopes

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 10, 2014
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 10, 2014

Record last verified: 2014-03

Locations

BR (1)