- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156284
Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 04023-061
- Federal University of São Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Empathic behaviour by nurses
Patients who received empathic behaviour was performed by a trained nurse.
|
Control group: patients without specific empathic behaviour Intervention group: patients who received the empathic behaviour was performed by a trained nurse. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Participants were followed for the duration of preoperative period, an expected average of 4 days.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Juliana L Lopes, PhD, Federal University of São Paulo
- Principal Investigator: Juliana S Jurko, Federal University of São Paulo
- Study Director: Alba Lucia B L Barros, PhD, Federal University of São Paulo
- Study Chair: Cinthia C Assis, PhD, Federal University of São Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U111111568736
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