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Completed

NCT Number: NCT07839598

Individualized Orem-Based Nursing Intervention After Coronary Artery Bypass Grafting

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jerash University

Amman, Dours, 009627, Jordan

About this study

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.

The primary longitudinal comparison was based on changes in outcomes over time between the intervention and control groups. Longitudinal outcome data were analyzed using linear mixed-effects models incorporating study group, assessment time, and the group-by-time interaction as fixed effects and participant as a random effect to account for repeated measurements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Individualized Nursing Intervention Program Based on Orem's Self-Care Theory

Behavioral

An individualized nursing intervention program based on Orem's Self-Care Theory, provided in addition to usual postoperative care. The program was tailored according to patients' identified 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.

Usual postoperative care

Other

Participants received usual postoperative care according to the routine care provided at the participating hospitals following coronary artery bypass grafting.

Primary outcomes

  1. Postoperative Learning Needs Scale (PLNS) Overall Score

    Time frame: 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.

Secondary outcomes

  1. CABG-Adapted Revised Self-Care Behaviors Scale (RSCB) Overall Score

    Time frame: Baseline, 3 months, and 6 months after CABG

    Self-care behaviors measured using the CABG-adapted Revised Self-Care Behaviors Scale (RSCB). The instrument contains 29 items scored from 0 to 5, yielding a possible total score of 0-145. Higher scores indicate more frequent performance of self-care behaviors.

  2. Cardiac Self-Efficacy Questionnaire (CSEQ) Overall Score

    Time frame: Baseline, 3 months, and 6 months after CABG

    Cardiac self-efficacy measured using the Cardiac Self-Efficacy Questionnaire (CSEQ). The 16-item questionnaire is scored from 0 to 4 per item, yielding a total score of 0-64. Higher scores indicate greater cardiac self-efficacy.

  3. Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score

    Time frame: Baseline, 3 months, and 6 months after CABG

    Anxiety symptoms measured using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The anxiety subscale contains 7 items and produces a score ranging from 0 to 21, with higher scores indicating greater anxiety symptoms.

  4. Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score

    Time frame: Baseline, 3 months, and 6 months after CABG

    Depressive symptoms measured using the depression subscale of the Hospital Anxiety and Depression Scale (HADS). The depression subscale contains 7 items and produces a score ranging from 0 to 21, with higher scores indicating greater depressive symptoms.

  5. Wound-Management Behaviors Score

    Time frame: Baseline, 3 months, and 6 months after CABG

    Wound-management behaviors measured using the wound-related items of the CABG-adapted Revised Self-Care Behaviors Scale (RSCB). The derived wound-management score ranges from 0 to 15, with higher scores indicating more frequent performance of wound-management behaviors.

  6. EQ-5D-5L Health-Status Visual Analogue Scale (VAS) Score

    Time frame: Baseline, 3 months, and 6 months after CABG

    Self-rated health status measured using the EQ-5D-5L visual analogue scale (VAS), recorded on a 0-100 scale. Higher scores indicate better self-rated health status.

  7. Study-Derived EQ-5D-5L Dimension-Sum Score

    Time frame: Baseline, 3 months, and 6 months after CABG

    Health status summarized using the study-derived EQ-5D-5L dimension-sum score. The five EQ-5D-5L dimension levels were summarized as a score ranging from 5 to 25. This score is study-derived and is not a preference-based EQ-5D-5L utility index; higher or lower values should be interpreted according to the scoring procedure used in the study.

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Sponsors and collaborators

Lead sponsor

Jerash Private University

Other

Registry information

Official study title

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

Acronym: CABG-OREM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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