Family Empathic Behaviour Versus Nurse Empathic Behaviour

• ClinicalTrials.gov Identifier: NCT02082951
• Recruitment Status: Completed
• First Posted: March 10, 2014
• Last Update Posted: March 10, 2014
• Sponsor: Juliana de Lima Lopes
• Information provided by (Responsible Party): Juliana de Lima Lopes, Federal University of São Paulo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Disease	Behavioral: Empathic behaviour by nurses.; Behavioral: Empathic behaviour by family.	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: Family Empathic Behaviour Versus Nurse Empathic Behaviour: Comparison of Anxiety Symptoms in the Preoperative Cardiac Surgery Patients
• Study Start Date: May 2011
• Actual Primary Completion Date: November 2012
• Actual Study Completion Date: December 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. The primary outcome was Anxiety. [ Time Frame: Participants were followed for the duration of preoperative period, an expected average of 4 days. ]

   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Brazil

Federal University of São Paulo

São Paulo, SP, Brazil, 04023-061

Sponsors and Collaborators

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

More Information

• Responsible Party: Juliana de Lima Lopes, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT02082951
• Other Study ID Numbers: UNIFESP23
• First Posted: March 10, 2014
• Last Update Posted: March 10, 2014
• Last Verified: March 2014

Additional relevant MeSH terms:

Cardiovascular Diseases