Coronary Artery Bypass Grafting (CABG) SurgeryCABG-OREMNCT07839598
Individualized Orem-Based Nursing Intervention After Coronary Artery Bypass Grafting
A study testing Individualized Nursing Intervention Program Based on Orem's Self-Care Theory and Usual postoperative care in people with Coronary Artery Bypass Grafting (CABG) Surgery, run by Jerash Private University at 1 site in Jordan.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass Grafting (CABG) Surgery
- What is being tested?
- Individualized Nursing Intervention Program Based on Orem's Self-Care Theory and Usual postoperative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteJordan
- Study dates
- 1 Aug 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Individualized Nursing Intervention Program Based on Orem's Self-Care Theory, Usual postoperative care
- Keywords
- Coronary artery bypass grafting, Orem's Self-Care Theory, Self-care, Nursing intervention, Patient education, Wound management, Quality of life, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Nursing Intervention Program Based on Orem's Self-Care TheoryBehavioural
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 careOther
Participants received usual postoperative care according to the routine care provided at the participating hospitals following coronary artery bypass grafting.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Individualized Nursing Intervention Program Based on Orem's Self-Care Theory; Other: Usual postoperative care |
| Control Group | Active comparator | Participants received usual postoperative care. Receives: Other: Usual postoperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Learning Needs Scale (PLNS) Overall Score
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.
Measured: Baseline, 3 months, and 6 months after CABG
Secondary outcomes (7)
CABG-Adapted Revised Self-Care Behaviors Scale (RSCB) Overall Score
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.
Measured: Baseline, 3 months, and 6 months after CABG
Cardiac Self-Efficacy Questionnaire (CSEQ) Overall Score
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.
Measured: Baseline, 3 months, and 6 months after CABG
Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
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.
Measured: Baseline, 3 months, and 6 months after CABG
Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
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.
Measured: Baseline, 3 months, and 6 months after CABG
Wound-Management Behaviors Score
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.
Measured: Baseline, 3 months, and 6 months after CABG
EQ-5D-5L Health-Status Visual Analogue Scale (VAS) Score
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.
Measured: Baseline, 3 months, and 6 months after CABG
Study-Derived EQ-5D-5L Dimension-Sum Score
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.
Measured: Baseline, 3 months, and 6 months after CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Grafting (CABG) SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jerash Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAWAD AHMAD ABU-SHENNAR, Jerash Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839598
- Sponsor's protocol ID
- CABG-OREM-2025-01
- Acronym
- CABG-OREM
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07839598
- Acronym / sponsor ID
- CABG-OREM / CABG-OREM-2025-01
- Keywords
- Coronary artery bypass grafting, Orem's Self-Care Theory, Self-care, Nursing intervention, Patient education, Wound management, Quality of life, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Jerash Private UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Individualized Nursing Intervention Program Based on Orem's Self-Care Theory, Other: Usual postoperative careParticipants 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. |
| Control Group | Active comparator | Other: Usual postoperative careParticipants received usual postoperative care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Nursing Intervention Program Based on Orem's Self-Care TheoryAn 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. | Behavioural | Intervention Group |
| Usual postoperative careParticipants received usual postoperative care according to the routine care provided at the participating hospitals following coronary artery bypass grafting. | Other | Control Group, Intervention Group |
Primary outcome
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.
7 secondary outcomes
CABG-Adapted Revised Self-Care Behaviors Scale (RSCB) Overall Score
Time frame: Baseline, 3 months, and 6 months after CABG
Cardiac Self-Efficacy Questionnaire (CSEQ) Overall Score
Time frame: Baseline, 3 months, and 6 months after CABG
Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Time frame: Baseline, 3 months, and 6 months after CABG
Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score
Time frame: Baseline, 3 months, and 6 months after CABG
Wound-Management Behaviors Score
Time frame: Baseline, 3 months, and 6 months after CABG
EQ-5D-5L Health-Status Visual Analogue Scale (VAS) Score
Time frame: Baseline, 3 months, and 6 months after CABG
Study-Derived EQ-5D-5L Dimension-Sum Score
Time frame: Baseline, 3 months, and 6 months after CABG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Bypass Grafting (CABG) Surgery
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
Prehabilitation, Cardiac Surgery
RecruitingObservational study
Prospective Study Protocol for Multiparametric PCCT Assessment of Early Ventricular Outcomes After CABG
Coronary Artery Bypass Grafting (CABG) Surgery, Coronary Artery Disease
Recruiting
Additional Effects of Flutter With Conventional Chest Physiotherapy on Peak Expiratory Flow Rate and Chest Expansion in Post CABG Patients With COPD
Peak Expiratory Flow Rate, Coronary Artery Bypass Graft Surgery
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Nursing Intervention Program Based on Orem's Self-Care Theory and Usual postoperative care in people with Coronary Artery Bypass Grafting (CABG) Surgery, run by Jerash Private University at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Learning Needs Scale (PLNS) Overall Score (time frame: Baseline, 3 months, and 6 months after CABG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.