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Completed

NCT Number: NCT02156284

Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery

The objective was to compare the frequency and intensity of symptoms of fear in patients of preoperative cardiac surgery who received empathic behaviour from nurse or those who received no specific type of empathic behaviour. This is a randomized clinical trial. The sample consisted of 44 patients in preoperative of cardiac surgery, who were divided in two groups: empathic behaviour by nurses and without specific empathic behaviour. Fear was assessed at two time points: before and after the intervention. The instrument used was developed and validated, comprising 15 defining characteristics of the nursing diagnosis fear. The hypothesis is that the group who received empathic behaviour from nurse 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 fear. Fear was assessed by a nurse using of an instrument developed and validated previous, based on 15 defining characteristics described by North American Nursing Diagnosis Association for the nursing diagnosis fear: apprehension, increased tension, exciting, nervousness, verbalization of fear (expressed concern), increased pulse, nausea, vomiting, fatigue, abnormal respiratory rate, increased perspiration, dry mouth, fear of death (reported), crying and impaired bowel motility.

Patients were evaluated for the presence and absence of these fear 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 15, with the higher the score, the greater was the fear 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
  • Patient who agreed to participate in the study by signing the consent form at least 24 hours prior to surgery

Exclusion criteria

  • Patients in preoperative cardiac transplantation
  • Patients who did not have at least two defining characteristics of the nursing diagnosis fear
  • Patients using anxiolytics
  • Smokers and / or patients who drank any amount of alcohol daily

Treatment and study plan

Empathic behaviour by nurses

Behavioral

Control group: patients without specific empathic behaviour

Intervention group: patients who received the empathic behaviour was performed by a trained nurse.

Primary outcomes

  1. The primary outcome was Fear.

    Time frame: Participants were followed for the duration of preoperative period, an expected average of 4 days.

    Fear was assessed by a nurse using an instrument developed and validated previous, based on 15 defining characteristics described by North American Nursing Diagnosis Association for the nursing diagnosis fear: apprehension, increased tension, exciting, nervousness, verbalization of fear (expressed concern), increased pulse, nausea, vomiting, fatigue, abnormal respiratory rate, increased perspiration, dry mouth, fear of death (reported), crying and impaired bowel motility.

    Patients were evaluated for the presence and absence of these fear 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 15, with the higher the score, the greater was the fear symptoms presented by the patient.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 5, 2014
Registry last updated
Jun 6, 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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