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Development of Open Heart Surgery Patient Care Protocol and Its Effect on Post-sternotomy Pain

Primary Purpose

Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Postoperative, Nursing Caries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Care Protocol
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart; Surgery, Heart, Functional Disturbance as Result focused on measuring Heart Surgery, pain, sternotomy, protocol, nursing

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with sternotomy who underwent Coronary Artery Bypass Graft surgery, Patient with sternotomy who underwent valve surgery, Being 18 years or older, Volunteering to participate in the research, Being at a level to adequately answer the questions asked cognitively, Experiencing pain at least once after the surgery, No complications (unable to wean from mechanical ventilator support, inability to discontinue inotropic support) until the period of transfer to the postoperative service. Exclusion Criteria: Desiring to leave the study group during the conduct of the research, Delirium development in the patient during the conduct of the study, The patient for whom emergency surgery has been decided.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Open Heart Surgery Patient Care Protocol

    Standart Care Protocol

    Arm Description

    Specific Practices for Pain in the Protocol Evaluation of patients' pain in the extubated period with the Visual Anolog Scale Active participation of the patient in pain reporting Regular questioning of the patient's pain Questioning pain at rest and movement Implementing nursing interventions in painful condition (VAS≤ 4)

    Standard care of intensive care will be given.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale
    Visual Analog Scale
    Scale for Evaluation of the Quality of Care Given to the Patient in Relief of Postoperative Pain
    The scale consists of 14 items and has 3 sub-dimensions related to nursing interventions, pain management and environment. Likert type scale was used in the evaluation. 1 means "strongly disagree" and 5 means "strongly agree". The scale Cronbach's coefficient was 0.81 and the main score obtained from the scale was 45.8 ± 10.8. The scale is a reliable and valid instrument in Turkish language.
    Analgesic use
    Number of analgesic use
    Type of analgesic
    Type of analgesic

    Secondary Outcome Measures

    Anxiety
    State Anxiety Scale The scale consists of a total of 20 items and each item is evaluated as (1) none, (2) a little, (3) a lot, (4) completely. There are direct and reversed statements in the scale. Positive emotions are defined by inverted statements, and those with a weight of 1 turn into a 4 in a rating, and a weight of 4 turns into a 1. In reversed statements, answers with a value of 1 indicate high anxiety, and those with a value of 4 indicate low anxiety. The total score of the reversed statements is subtracted from the calculated direct statement score, and the unchanged value 50 is added to the resulting number. The total score is between 20-80. According to the score calculated on the scale, 0-19 means no anxiety, 20-39 means mild, 40-59 moderate, 60-79 high anxiety.
    Blood pressure
    Measuring arterial blood pressure Systolic blood pressure (the first and higher number) measures pressure inside your arteries when the heart beats. Diastolic blood pressure (the second and lower number) measures the pressure inside the artery when the heart rests between beats.
    respiratory
    respiratory rate
    Fever
    Temperature measurement. A fever is a body temperature that is higher than normal. A normal temperature can vary from person to person, but it is usually around 98.6 °F (37 °C).
    Heart rate
    Heart rate measurement. A normal resting heart rate for adults ranges from 60 to 100 beats per minute.
    Oxygen Saturation
    Oxygen saturation can be measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level. A pulse oximeter can measure oxygen saturation. It is a noninvasive device placed over a person's finger. It measures light wavelengths to determine the ratio of the current levels of oxygenated hemoglobin to deoxygenated hemoglobin. The use of pulse oximetry has become a standard of care in medicine.
    Partial pressure of carbon dioxide
    Blood gases are a measurement of how much oxygen and carbon dioxide are in your blood. They also determine the acidity (pH) of your blood. The partial pressure of carbon dioxide (PCO2) is the measure of carbon dioxide within arterial or venous blood. It often serves as a marker of sufficient alveolar ventilation within the lungs. Generally, under normal physiologic conditions, the value of PCO2 ranges between 35 to 45 mmHg, or 4.7 to 6.0 kPa.
    Partial pressure of oxygen
    Blood gases are a measurement of how much oxygen and carbon dioxide are in your blood. They also determine the acidity (pH) of your blood.Partial pressure of oxygen (PaO2): 75 to 100 millimeters of mercury (mm Hg), or 10.5 to 13.5 kilopascal (kPa)

    Full Information

    First Posted
    June 5, 2023
    Last Updated
    September 18, 2023
    Sponsor
    Kutahya Health Sciences University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05902052
    Brief Title
    Development of Open Heart Surgery Patient Care Protocol and Its Effect on Post-sternotomy Pain
    Official Title
    Master of Science, Registery Nurse
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 25, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kutahya Health Sciences University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Open heart surgery method is generally used in the treatment of cardiovascular diseases. Sternotomy is the process of opening the sternum. After sternotomy, individuals experience ongoing pain in the anterior thorax. Despite developing pain methods and treatments, individuals undergoing cardiovascular surgery suffer from pain that cannot be managed well. Patients undergoing cardiac surgery experience severe pain for the first 48 hours and are in intensive care during this period. Pain is the most important stress factor for intensive care patients. The nurse and health care team should play a key role and take an active role in the management and evaluation of pain. However, there are not enough studies trying to define the role of the nurse in the management of postoperative pain. Protocols are used to provide pain management and routine pain assessment in intensive care units. The use of protocols provides maximum care to the patient, while reducing the cost. It also ensures the patient's participation in the treatment. While protocols ensure that practices are converted into evidence-based ones, they also prevent disruptions in treatment. As a result, management of the pain experiences of patients with sternotomy who underwent open heart surgery in the intensive care unit with the developed protocol; It will guide the improvement and development of pain management. It is thought that the protocol will address the pain of individuals undergoing open heart surgery in a holistic way. In addition, no study has been found in the literature that includes the development of a protocol for the pain of intensive care patients undergoing open heart surgery. For this reason, it is thought that the study will shed light on the literature by being a resource in the management and improvement of pain.
    Detailed Description
    In this study, it is aimed to develop the open heart surgery patient care protocol and to examine its effect on the pain that develops after sternotomy. The research is planned to be carried out on the patients in the Cardiovascular Surgery Intensive Care Unit of Research Hospital. The sample size of this study was decided by power analysis. The G-Power statistics program is based on Type 1 error 0.05 and 80% power. In the power analysis of Akbayrak and Tosun's (2002) thesis study, using the results showing the average score of the satisfaction level of the patients with and without the care protocol, the sample size was determined as 17 patients for each group and 34 patients in total. However, in order to meet the parametric test assumptions, it was decided to include at least 30 people in each group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Postoperative, Nursing Caries
    Keywords
    Heart Surgery, pain, sternotomy, protocol, nursing

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Open Heart Surgery Patient Care Protocol
    Arm Type
    Experimental
    Arm Description
    Specific Practices for Pain in the Protocol Evaluation of patients' pain in the extubated period with the Visual Anolog Scale Active participation of the patient in pain reporting Regular questioning of the patient's pain Questioning pain at rest and movement Implementing nursing interventions in painful condition (VAS≤ 4)
    Arm Title
    Standart Care Protocol
    Arm Type
    No Intervention
    Arm Description
    Standard care of intensive care will be given.
    Intervention Type
    Other
    Intervention Name(s)
    Care Protocol
    Intervention Description
    Evaluation of patients' pain in the extubated period with the Visual Anolog Scale Active participation of the patient in pain reporting Regular questioning of the patient's pain Questioning pain at rest and movement Implementing nursing interventions in painful condition (VAS≤ 4)
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale
    Description
    Visual Analog Scale
    Time Frame
    3 days
    Title
    Scale for Evaluation of the Quality of Care Given to the Patient in Relief of Postoperative Pain
    Description
    The scale consists of 14 items and has 3 sub-dimensions related to nursing interventions, pain management and environment. Likert type scale was used in the evaluation. 1 means "strongly disagree" and 5 means "strongly agree". The scale Cronbach's coefficient was 0.81 and the main score obtained from the scale was 45.8 ± 10.8. The scale is a reliable and valid instrument in Turkish language.
    Time Frame
    Just before being transferred to intensive care
    Title
    Analgesic use
    Description
    Number of analgesic use
    Time Frame
    3 days
    Title
    Type of analgesic
    Description
    Type of analgesic
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    Anxiety
    Description
    State Anxiety Scale The scale consists of a total of 20 items and each item is evaluated as (1) none, (2) a little, (3) a lot, (4) completely. There are direct and reversed statements in the scale. Positive emotions are defined by inverted statements, and those with a weight of 1 turn into a 4 in a rating, and a weight of 4 turns into a 1. In reversed statements, answers with a value of 1 indicate high anxiety, and those with a value of 4 indicate low anxiety. The total score of the reversed statements is subtracted from the calculated direct statement score, and the unchanged value 50 is added to the resulting number. The total score is between 20-80. According to the score calculated on the scale, 0-19 means no anxiety, 20-39 means mild, 40-59 moderate, 60-79 high anxiety.
    Time Frame
    Before going into surgery, Just before being transferred to intensive care
    Title
    Blood pressure
    Description
    Measuring arterial blood pressure Systolic blood pressure (the first and higher number) measures pressure inside your arteries when the heart beats. Diastolic blood pressure (the second and lower number) measures the pressure inside the artery when the heart rests between beats.
    Time Frame
    3 days
    Title
    respiratory
    Description
    respiratory rate
    Time Frame
    3 days
    Title
    Fever
    Description
    Temperature measurement. A fever is a body temperature that is higher than normal. A normal temperature can vary from person to person, but it is usually around 98.6 °F (37 °C).
    Time Frame
    3 days
    Title
    Heart rate
    Description
    Heart rate measurement. A normal resting heart rate for adults ranges from 60 to 100 beats per minute.
    Time Frame
    3 days
    Title
    Oxygen Saturation
    Description
    Oxygen saturation can be measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level. A pulse oximeter can measure oxygen saturation. It is a noninvasive device placed over a person's finger. It measures light wavelengths to determine the ratio of the current levels of oxygenated hemoglobin to deoxygenated hemoglobin. The use of pulse oximetry has become a standard of care in medicine.
    Time Frame
    3 days
    Title
    Partial pressure of carbon dioxide
    Description
    Blood gases are a measurement of how much oxygen and carbon dioxide are in your blood. They also determine the acidity (pH) of your blood. The partial pressure of carbon dioxide (PCO2) is the measure of carbon dioxide within arterial or venous blood. It often serves as a marker of sufficient alveolar ventilation within the lungs. Generally, under normal physiologic conditions, the value of PCO2 ranges between 35 to 45 mmHg, or 4.7 to 6.0 kPa.
    Time Frame
    3 days
    Title
    Partial pressure of oxygen
    Description
    Blood gases are a measurement of how much oxygen and carbon dioxide are in your blood. They also determine the acidity (pH) of your blood.Partial pressure of oxygen (PaO2): 75 to 100 millimeters of mercury (mm Hg), or 10.5 to 13.5 kilopascal (kPa)
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient with sternotomy who underwent Coronary Artery Bypass Graft surgery, Patient with sternotomy who underwent valve surgery, Being 18 years or older, Volunteering to participate in the research, Being at a level to adequately answer the questions asked cognitively, Experiencing pain at least once after the surgery, No complications (unable to wean from mechanical ventilator support, inability to discontinue inotropic support) until the period of transfer to the postoperative service. Exclusion Criteria: Desiring to leave the study group during the conduct of the research, Delirium development in the patient during the conduct of the study, The patient for whom emergency surgery has been decided.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Necibe Dagcan, Msc RN
    Phone
    05537011935
    Email
    necibedagcan35@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Development of Open Heart Surgery Patient Care Protocol and Its Effect on Post-sternotomy Pain

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