Clinical trial NCT05902052: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart; Surgery, Heart, Functional Disturbance as Result
Pain, Postoperative
Nursing Caries
Keywords: Heart Surgery
pain
sternotomy
protocol
nursing
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 3 days
measure: Scale for Evaluation of the Quality of Care Given to the Patient in Relief of Postoperative Pain
timeFrame: Just before being transferred to intensive care
measure: Analgesic use
timeFrame: 3 days
measure: Type of analgesic
timeFrame: 3 days
Secondary outcomes:
measure: Anxiety
timeFrame: Before going into surgery, Just before being transferred to intensive care
measure: Blood pressure
timeFrame: 3 days
measure: respiratory
timeFrame: 3 days
measure: Fever
timeFrame: 3 days
measure: Heart rate
timeFrame: 3 days
measure: Oxygen Saturation
timeFrame: 3 days
measure: Partial pressure of carbon dioxide
timeFrame: 3 days
measure: Partial pressure of oxygen
timeFrame: 3 days
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Izmir Atatürk Training and research hospital
Study officials:
References: