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Completed

NCT Number: NCT05667467

The Effect of Care Bundle in Heart Surgery

This study is a quasi-experimental (non-randomized) design study with control and study group patients undergoing open heart surgery. The main purpose of the research to examine the effect of the care bundle application on the quality of recovery and respiratory patterns (respiratory rate, presence of dyspnea, oxygen saturation, etc.) in patients with open heart surgery. The other purpose is examine the compliance rates of nurses in the implementation of the cardiac surgery care bundle on patients. In the study, nurses working in the cardiovascular surgery clinic and surgical intensive care unit in a training and research hospital in southeast Turkey voluntarily applied the care bundle created by the researcher to the patients in the study group. When the data of the study were examined, it was seen that the respiratory patterns and recovery status of the patients who received the care bundle were better. However, it was determined that the compliance rate of the nurses to the care bundle was not at the desired level.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yasemin Yılmaz

Sanliurfa, Haliliye, Turkey (Türkiye)

About this study

Introduction: There are several ways to transfer evidence-based practice to the clinic. One of them is "care bundle" implementation.

Purpose: To examine the effect of applying the "Cardiac Surgery Care Bundle" which consists of evidence-based applications, on patients with open heart surgery (AKC) on the quality of recovery and respiratory patterns (respiratory rate, presence of dyspnea, oxygen saturation, etc.). In the study, the compliance status of nurses in the implementation of the care bundle was also examined.

Method:This research is a quasi-experimental, non-randomized study with AKC applied control and study groups. In the study, volunteer nurses working in the surgical intensive care and cardiovascular surgery clinics applied the care bundle created by the researcher to the patients in the study group. care bundle; It includes "Informing the Patients and Their Relatives", "Respiratory Management" and "Early Mobilization" implementations. A total of 103 patients, 69 of whom were control and 34 were study, were included in the study. First, the data of the control group and then the study group were collected. Patients in the control group received standard care, while the study group received a care bundle in addition to the standard care. Data were obtained using the "Descriptive Characteristics Data Form", "Patient Outcomes for Complications Form" and the "Quality of Recovery-40-QoR-40".

Statistical analyses were performed using the IBM SPSS for Windows 22.0 software. The variables were analyzed for normality of distribution using skewness and kurtosis coefficients. Normally distributed variables were presented using mean ± standard deviation values and non-normally distributed variables were presented using median (minimum-maximum) values. Differences between two samples were analyzed using the "Independent Samples t test" when the assumption of normality was met, and using the "Mann-Whitney U" test when the assumption of normality was not met. Categorical variables were analyzed using Chi-square or Fisher's exact tests. Statistical significance was set at p < 0.05.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inclusion Criteria for Patients
  • 18 years and older,
  • Elective AKC planned
  • Those who will undergo cardiac surgery for the first time
  • Extubated after cardiac surgery and not given sedating drugs
  • No communication barrier (including hearing and vision problems),
  • Does not have a musculoskeletal disease or neurological problem that will prevent walking after surgery,
  • Does not have any respiratory disease,
  • Psychiatric, not diagnosed with mental illness,
  • Those who volunteered to participate in the research
  • Patients who are 18 years of age or older who volunteer to participate in the research.
  • Inclusion Criteria for Nurses
  • Working as a nurse in cardiovascular surgery clinic or surgical intensive care clinic,
  • It is the nurses who volunteer to participate in the research.

Exclusion criteria

  • Exclusion Criteria for Patients
  • Patients with active bleeding after surgery
  • Developing neurological complications
  • Complications that prevent the patient from standing up after surgery
  • Those with respiratory problems that will delay weaning from the mechanical ventilator
  • Re-operated due to the development of any complication
  • Those who want to leave the research during the pre- or post-surgical research process
  • These are the patients who develop a situation where they cannot continue to accompany the patient while they are accompanying the patient, or who are the relatives of the patients who want to leave the research during the research process.
  • Exclusion Criteria for Nurses
  • Assigned to another clinic during the research process,
  • Resigned from his job during the research process,
  • Nurses who want to leave the study during any phase of the study.

Treatment and study plan

Care Bundle Implementation

Procedure

In this study, the control group received standard care. The nurse group was given training on the implementation of the care bundle. A "cardiac surgery care bundle" was applied to the study group by clinical nurses.

Primary outcomes

  1. The effect of the care bundle on the recovery status of the patients

    Time frame: One week after surgery

    In the study, the recovery status of patients after surgery was measured with the "Recovery Quality-40 Questionnaire". The contribution of the cardiac surgery care bundle applied to the study group by the clinical nurses to the recovery status was examined.

Secondary outcomes

  1. Examination of nurses' compliance with the care bundle

    Time frame: One week after the data collection process of the study group patients was completed.

    In this study, nurses' compliance rates to the care bundle (application rates to patients) were examined. According to the literature, compliance should be at least 95% in order to have a high level of compliance with the care bundle.

Sponsors and collaborators

Lead sponsor

Harran University

Other

Registry information

Official study title

Investigation of the Effect of Care Bundle Implementation on Recovery Process in Open Heart Surgery Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2022
Registry last updated
Dec 28, 2022

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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