Family Empathic Behaviour Versus Nurse Empathic Behaviour

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082951
• Other study ID #: UNIFESP23
• Status: Completed
• Phase: N/A
• First received: March 3, 2014
• Last updated: March 6, 2014
• Start date: May 2011
• Est. completion date: December 2012

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• 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;

• 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Empathic behaviour by nurses.
The empathic behaviour in group 1 was performed by a trained nurse.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Juliana de Lima Lopes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No