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Completed

NCT Number: NCT02082951

Family Empathic Behaviour Versus Nurse Empathic Behaviour

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo

São Paulo, 04023-061, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Empathic behaviour by nurses.

Behavioral

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

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Juliana de Lima Lopes

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 10, 2014
Registry last updated
Mar 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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