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A Structured Nurse-Led Empowerment Program to Improve Knowledge, Practical Skills, and Self-Care Behaviours in Patients Living With a Permanent Pacemaker

Effect of a Structured Nurse-Led Empowerment Protocol on Knowledge, Practical Skills, and Self-Care Behaviours Among Patients With Permanent Pacemakers: A Quasi-Experimental Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07743346
Enrollment
70
Registered
2026-08-03
Start date
2025-12-30
Completion date
2026-05-08
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Permanent Pacemaker

Brief summary

This study evaluates whether a structured nurse-led education and empowerment program improves knowledge, practical self-care skills, and self-care behaviors in adult patients who have recently received a permanent pacemaker. Seventy participants were assigned to either the structured program, consisting of three individual teaching sessions with illustrated booklets and hands-on demonstration delivered within the first week after implantation, or standard hospital care. Outcomes were measured at baseline, immediately after the intervention, and at one-month follow-up using validated knowledge, practice, and self-care questionnaires.

Detailed description

Patients with newly implanted permanent pacemakers often lack sufficient knowledge and practical skills for self-care, which can affect long-term outcomes and quality of life. This quasi-experimental study used a non-equivalent control-group, pretest-posttest design to evaluate a structured nurse-led empowerment protocol grounded in Bandura's Self-Efficacy Theory, Orem's Self-Care Deficit Nursing Theory, and patient-empowerment principles. The intervention consisted of three individual teaching sessions (30-45 minutes each) delivered within the first week after pacemaker implantation, using Arabic-language illustrated booklets and a demonstration/return-demonstration technique. The study was conducted in the cardiac intensive care unit, inpatient wards, and outpatient clinics of Tanta University Hospitals, Egypt.

Interventions

BEHAVIORALStructured Nurse-Led Empowerment Program

Three individual teaching sessions (30-45 minutes each) using Arabic-language illustrated booklets and a demonstration/return-demonstration technique, delivered within the first week after pacemaker implantation. Sessions covered pacemaker function, wound care, activity precautions, device follow-up, and warning signs requiring medical attention.

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Participants were assigned to either the structured empowerment program (intervention) or standard care (control) in a non-equivalent control-group design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * First-time permanent pacemaker implantation * Admission to the cardiology department * Willingness to provide written informed consent

Exclusion criteria

* Documented psychiatric or cognitive disorders * Inability to cooperate with the protocol

Design outcomes

Primary

MeasureTime frameDescription
Change in Patient Knowledge ScoreBaseline, immediately post-intervention, and at 1-month follow-upPatient knowledge about pacemaker function, wound care, activity precautions, and warning signs, measured using a validated knowledge questionnaire (score range 0-20). Higher scores indicate greater knowledge.

Secondary

MeasureTime frameDescription
Title: Change in Self-Care Behaviours ScoreBaseline, immediately post-intervention, and at 1-month follow-upSelf-care behaviours measured using the Self-Care Behaviours Scale (score range 0-20). Higher scores indicate better self-care behaviours.
Change in Practical Skills Competence ScoreBaseline, immediately post-intervention, and at 1-month follow-upPractical self-care skills assessed using a validated Observational Checklist (score range 0-50). Higher scores indicate greater competence.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026