A Nurse Caring Behavior Protocol on Postoperative Cardiac Patient Satisfaction

July 1, 2022 updated by: Suad Elsaman, Alexandria University

Impact of Implementing a Nurse Caring Behavior Protocol on Postoperative Cardiac Patient Satisfaction: A Randomized Controlled Trial

the study aimed to evaluate the impact of implementing a nurse caring behavior (NCB) protocol on postoperative cardiac patient satisfaction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Critical care nurses need to comply with caring behaviors when caring for postoperative cardiac patients. Furthermore, patient satisfaction is a key indicator of nursing care quality. As such, this study focused on these critical issues considering the limited research available on the impact of caring behaviors on postoperative cardiac patient satisfaction. The study aimed to evaluate the impact of implementing a nurse caring behavior protocol on postoperative cardiac patient satisfaction. The study was conducted at a cardiac surgery intensive care unit of Alexandria Main University Hospital, Egypt. Sixty adults, conscious cardiac surgery patients, were included during the first 2 days following surgery. Patients were randomly assigned to either a control group, which received routine nursing care, or a protocol group, which received nursing care based on nurse care behaviors protocol through a simple randomization method. One tool was used "Postoperative Cardiac Patient Satisfaction with Nurse Caring Behaviors Evaluation Questionnaire". At the end of the second day, patients were asked regarding their satisfaction with the nursing care received based on caring behaviors. These nursing care included intensive care unit admission and orientation processes, physical care, psychological care, and social interaction between patient and nurse, providing health teaching, and maintaining a safe healing environment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21548
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Underwent cardiac surgery.

Exclusion Criteria:

  • Unstable hemodynamics (systolic blood pressure less than 90).
  • Uncontrolled dysrhythmias.
  • Hemorrhage.
  • Uncontrolled diabetes mellitus.
  • Chronic respiratory diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: A protocol group
A protocol group received a nurse caring behavior protocol by the researcher
Other: A nurse caring behavior protocol

Nursing interventions based on caring behaviors protocol was provided as follows:

  • Caring behaviors during ICU admission and orientation processes included orienting patients to time, place, and person.
  • Caring behaviors during physical care informing patients regarding the purpose and expected duration of mechanical ventilator use.
  • Caring behaviors during psychological care included offering religious sound meditation.
  • Caring behaviors during social interaction included maintaining eye contact during nurse-patient interaction.
  • Caring behaviors during health teaching included providing health teaching for patients.
  • Caring behaviors during maintaining a safe healing environment included providing patients with an explanation regarding nursing activities.
ACTIVE_COMPARATOR: A control group
A control group received routine nursing care by the staff nurse
Other: Routine nursing care
Routine nursing care was concentrated mainly on hard skills of physically demanding care such as monitoring vital signs.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction with Intensive care unit admission and orientation processes based on caring behaviors questionnaire:
Time Frame: At the end of the second postoperative day
The questionnaire includes statement items on nursing interventions based on nurse caring behaviors related to admission and orientation process such as (Nurses welcoming and identify themselves to the patients, Orientation provided by the nurse regarding time, place, and person and Orientation provided by the nurse regarding nursing activities that will be done). Each statement item was rated on a dichotomous scale of (satisfied, dissatisfied) after the researcher asked the patients to report whether they were satisfied with the care provided. Each statement item was scored as follows: satisfied = 1 and dissatisfied = 0.
At the end of the second postoperative day
Patient satisfaction with physical care based on caring behaviors questionnaire:
Time Frame: At the end of the second postoperative day
The questionnaire includes statement items on nursing interventions based on nurse caring behaviors related to physical care which was provided to the patients such as (The manner at which nurses talk to patients, The ability of nurses to establish realistic goals, Responding to patient complaints, Nurse's helpfulness Nurses' availability, Praising the patients for performing activities). Each statement item was rated on a dichotomous scale of (satisfied, dissatisfied) after the researcher asked the patients to report whether they were satisfied with the care provided. Each statement item was scored as follows: satisfied = 1 and dissatisfied = 0.
At the end of the second postoperative day
Patient satisfaction with psychological care based on caring behaviors questionnaire.
Time Frame: At the end of the second postoperative day
The questionnaire includes statement items on nursing interventions based on nurse caring behaviors related to psychological care which was provided to the patients such as (Dealing with patients and providing enthusiasm, Level of confidentiality that nurses provided to patients, Always repeating statements that instilled hope). Each statement item was rated on a dichotomous scale of (satisfied, dissatisfied) after the researcher asked the patients to report whether they were satisfied with the care provided. Each statement item was scored as follows: satisfied = 1 and dissatisfied = 0.
At the end of the second postoperative day
Patient satisfaction with social interaction based on caring behaviors questionnaire.
Time Frame: At the end of the second postoperative day
The questionnaire includes statement items on nursing interventions based on nurse caring behaviors related to social interaction between patient and nurse such as (Duration of time nurses' spent with patients, Maintaining a cheerful disposition, Making patients feel at home, Nurse's ability to provide verbal reassurance, Nurse's ability to use the eye-to-eye contact with the patient). Each statement item was rated on a dichotomous scale of (satisfied, dissatisfied) after the researcher asked the patients to report whether they were satisfied with the care provided. Each statement item was scored as follows: satisfied = 1 and dissatisfied = 0.
At the end of the second postoperative day
Patient satisfaction with health teaching based on caring behaviors questionnaire.
Time Frame: At the end of the second postoperative day
The questionnaire includes statement items on nursing interventions based on nurse caring behaviors related to health teaching which was provided to the patients such as (Information provided by the nurse regarding diagnosis, your rights, and treatment plan, Information provided by the nurse regarding postoperative activity, Information provided by the nurse regarding diagnostic procedures, Feasibility and clearness of the information provided by the nurse, Time at which the nurse provided information was enough and suitable for the patient). Each statement item was rated on a dichotomous scale of (satisfied, dissatisfied) after the researcher asked the patients to report whether they were satisfied with the care provided. Each statement item was scored as follows: satisfied = 1 and dissatisfied = 0.
At the end of the second postoperative day
Patient satisfaction with maintaining a safe healing environment based on caring behaviors questionnaire
Time Frame: At the end of the second postoperative day
The questionnaire includes statement items on nursing interventions based on nurse caring behaviors related to maintaining a safe healing environment such as (Availability of comfort measures, such as lighting, noise control, and adequate blankets, Cleanliness and ventilation of the intensive care unit, Adequacy of sleeping time, Keeping patients away from unpleasant scenes, Availability glasses, hearing aids, and familiar objects). Each statement item was rated on a dichotomous scale of (satisfied, dissatisfied) after the researcher asked the patients to report whether they were satisfied with the care provided. Each statement item was scored as follows: satisfied = 1 and dissatisfied = 0.
At the end of the second postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Alexandria University, Faculty of Nursing, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • patient satisfaction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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