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

NCT05902052 | Completed

• 1 other identifier: KutahyaHSU-NECİBE-DAĞCAN-0001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Heart Surgery; pain; sternotomy; protocol; nursing

Outcome Measures

Primary Outcomes (4)

• Visual Analog Scale

  Visual Analog Scale

  3 days

• 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

• Analgesic use

  Number of analgesic use

  3 days

• Type of analgesic

  Type of analgesic

  3 days

Secondary Outcomes (8)

• Anxiety

  Before going into surgery, Just before being transferred to intensive care

• Blood pressure

  3 days

• respiratory

  3 days

• Fever

  3 days

• Heart rate

  3 days

Study Arms (2)

Open Heart Surgery Patient Care Protocol

EXPERIMENTAL

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)

Other: Care Protocol

Standart Care Protocol

NO INTERVENTION

Standard care of intensive care will be given.

Interventions

Care Protocol 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)

Open Heart Surgery Patient Care Protocol

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Izmir Atatürk Training and research hospital

Izmir, 35000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

CARE protocol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: December 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)