Effectiveness of an Individualized Self-Care and Nursing Intervention Program Based on Orem's Self-Care Theory on Learning Needs, Self-Efficacy, Self-Care Behaviors, Quality of Life, Anxiety, Depression, and Wound Management Among Patients Following Coronary Artery Bypass Grafting: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Postoperative Learning Needs Scale (PLNS) Overall Score
研究概览
简要总结
This randomized controlled trial will evaluate the effectiveness of an individualized self-care and nursing intervention program based on Orem's Self-Care Theory among patients following coronary artery bypass grafting (CABG). The program is designed to address patients' learning needs, strengthen self-efficacy, promote self-care behaviors and wound-management practices, and improve quality of life while reducing anxiety and depression during postoperative recovery. Participants will be randomly assigned in a 1:1 ratio to either the individualized Orem-based self-care and nursing intervention program in addition to usual care or usual care alone. Outcomes will be assessed at baseline, 3 months, and 6 months after the intervention. The study will be conducted in cardiology departments and cardiac intensive care units of hospitals affiliated with the Jordanian Ministry of Health in Jordan.
详细描述
This prospective, two-group, parallel randomized controlled trial evaluated an individualized self-care and nursing intervention program based on Orem's Self-Care Theory among patients following coronary artery bypass grafting (CABG).
The study was conducted in cardiology departments and cardiac intensive care units (CCUs/CICUs) of hospitals affiliated with the Jordanian Ministry of Health in Jordan. Participants were recruited from August 2025 to February 2026, and follow-up assessments continued for 6 months.
A total of 440 eligible patients were randomly allocated in a 1:1 ratio to either the intervention group or the control group. The intervention group received an individualized Nursing Intervention Program Based on Orem's Self-Care Theory in addition to usual postoperative care, whereas the control group received usual postoperative care. The intervention was designed to address patients' individual learning needs and self-care requirements during recovery following CABG.
The intervention incorporated individualized education and nursing support addressing postoperative recovery, medication management, physical activity and gradual mobilization, dietary and lifestyle recommendations, symptom monitoring, recognition of warning signs and complications, surgical wound care, self-care behaviors, cardiac self-efficacy, psychological adjustment, problem-solving, decision-making, and long-term cardiovascular self-management. Educational content was tailored according to each participant's identified learning needs, self-care difficulties, postoperative symptoms, functional limitations, and barriers to recommended self-care.
Participants were assessed at baseline and at 3- and 6-month follow-up. Study outcomes included postoperative learning needs, self-care behaviors, cardiac self-efficacy, anxiety, depression, wound-management behaviors, and health-related quality of life. The study used standardized assessment instruments, including the Postoperative Learning Needs Scale, a CABG-adapted self-care behavior measure, the Cardiac Self-Efficacy Questionnaire, the Hospital Anxiety and Depression Scale, and the EQ-5D-5L.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who had undergone coronary artery bypass grafting (CABG).
- •Clinically stable following surgery.
- •Able to communicate and complete the study questionnaires.
- •Willing to provide written informed consent.
- •Access to a telephone to facilitate post-discharge follow-up and communication during the recovery period.
排除标准
- •Clinical or cognitive conditions that substantially interfered with participation in the individualized self-care program or completion of the outcome assessments.
- •Major postoperative conditions that could independently influence recovery and self-care performance, including major postoperative complications such as stroke or severe wound infection.
研究组 & 干预措施
Intervention Group
Participants received an individualized Nursing Intervention Program based on Orem's Self-Care Theory in addition to usual postoperative care. The program was individualized according to patients' learning needs, self-care difficulties and capacity, postoperative symptoms, functional limitations, and barriers to recommended self-care. It addressed postoperative recovery, medication management, physical activity and gradual mobilization, dietary and lifestyle recommendations, symptom monitoring, recognition of warning signs and complications, surgical wound care, self-care behaviors, cardiac self-efficacy, psychological adjustment, problem-solving, decision-making, and long-term cardiovascular self-management.
干预措施: Individualized Nursing Intervention Program Based on Orem's Self-Care Theory (Behavioral)
Intervention Group
Participants received an individualized Nursing Intervention Program based on Orem's Self-Care Theory in addition to usual postoperative care. The program was individualized according to patients' learning needs, self-care difficulties and capacity, postoperative symptoms, functional limitations, and barriers to recommended self-care. It addressed postoperative recovery, medication management, physical activity and gradual mobilization, dietary and lifestyle recommendations, symptom monitoring, recognition of warning signs and complications, surgical wound care, self-care behaviors, cardiac self-efficacy, psychological adjustment, problem-solving, decision-making, and long-term cardiovascular self-management.
干预措施: Usual postoperative care (Other)
Control Group
Participants received usual postoperative care.
干预措施: Usual postoperative care (Other)
结局指标
主要结局
Postoperative Learning Needs Scale (PLNS) Overall Score
时间窗: Baseline, 3 months, and 6 months after CABG
Postoperative learning needs measured using the overall score of the Postoperative Learning Needs Scale (PLNS), with a possible score range of 0-65. Higher scores indicate greater postoperative learning needs.
次要结局
- CABG-Adapted Revised Self-Care Behaviors Scale (RSCB) Overall Score(Baseline, 3 months, and 6 months after CABG)
- Cardiac Self-Efficacy Questionnaire (CSEQ) Overall Score(Baseline, 3 months, and 6 months after CABG)
- Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score(Baseline, 3 months, and 6 months after CABG)
- Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score(Baseline, 3 months, and 6 months after CABG)
- Wound-Management Behaviors Score(Baseline, 3 months, and 6 months after CABG)
- EQ-5D-5L Health-Status Visual Analogue Scale (VAS) Score(Baseline, 3 months, and 6 months after CABG)
- Study-Derived EQ-5D-5L Dimension-Sum Score(Baseline, 3 months, and 6 months after CABG)
研究者
JAWAD AHMAD ABU-SHENNAR
ASST.PROF.DR
Jerash Private University