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Clinical Trials/NCT07743346
NCT07743346CompletedNot Applicable

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

Kafrelsheikh University1 site in 1 country70 target enrollmentStarted: December 30, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Change in Patient Knowledge Score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Change in Patient Knowledge Score

Time Frame: Baseline, immediately post-intervention, and at 1-month follow-up

Patient 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 Outcomes

  • Title: Change in Self-Care Behaviours Score(Baseline, immediately post-intervention, and at 1-month follow-up)
  • Change in Practical Skills Competence Score(Baseline, immediately post-intervention, and at 1-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nahla Mohamed Mahmoud Afify

Lecturer of Critical Care & Emergency Nursing

Kafrelsheikh University

Study Sites (1)

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