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

NCT ID: NCT05902052

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Open Heart Surgery Patient Care Protocol

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)

Group Type: EXPERIMENTAL

Care Protocol

Intervention Type: OTHER

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)

Standart Care Protocol

Standard care of intensive care will be given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kutahya Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Necibe Dağcan

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Izmir Atatürk Training and research hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KutahyaHSU-NECİBE-DAĞCAN-0001

Identifier Type: -

Identifier Source: org_study_id