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

Pain, Postoperative Clinical Trial

Official title:

Master of Science, Registery Nurse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05902052
• Other study ID #: KutahyaHSU-NECIBE-DAGCAN-0001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Care 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)

Locations

Country	Name	City	State
Turkey	Izmir Atatürk Training and research hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	Visual Analog Scale	3 days
Primary	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.	Just before being transferred to intensive care
Primary	Analgesic use	Number of analgesic use	3 days
Primary	Type of analgesic	Type of analgesic	3 days
Secondary	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.	Before going into surgery, Just before being transferred to intensive care
Secondary	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.	3 days
Secondary	respiratory	respiratory rate	3 days
Secondary	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).	3 days
Secondary	Heart rate	Heart rate measurement. A normal resting heart rate for adults ranges from 60 to 100 beats per minute.	3 days
Secondary	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.	3 days
Secondary	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.	3 days
Secondary	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)	3 days