Permanent PacemakerNCT07743346
A Structured Nurse-Led Empowerment Program to Improve Knowledge, Practical Skills, and Self-Care Behaviours in Patients Living With a Permanent Pacemaker
A study testing Structured Nurse-Led Empowerment Program in people with Permanent Pacemaker, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Permanent Pacemaker
- What is being tested?
- Structured Nurse-Led Empowerment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2025to 8 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- First-time permanent pacemaker implantation
- Admission to the cardiology department
- Willingness to provide written informed consent
Who cannot join
- Documented psychiatric or cognitive disorders
- Inability to cooperate with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Permanent Pacemaker
- Being tested
- Structured Nurse-Led Empowerment Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Nurse-Led Empowerment ProgramBehavioural
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.
Structured Nurse-Led Empowerment ProgramBehavioural
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 i
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Participants received standard hospital care only, without the structured empowerment program. |
| Intervention Group | Experimental | Participants received the structured nurse-led empowerment program, consisting of three individual teaching sessions with illustrated booklets and demonstration/return-demonstration, delivered within the first week after pacemaker implantation, in addition to standard hospital care. Receives: Behavioral: Structured Nurse-Led Empowerment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Knowledge Score
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.
Measured: Baseline, immediately post-intervention, and at 1-month follow-up
Secondary outcomes (2)
Title: Change in Self-Care Behaviours Score
Self-care behaviours measured using the Self-Care Behaviours Scale (score range 0-20). Higher scores indicate better self-care behaviours.
Measured: Baseline, immediately post-intervention, and at 1-month follow-up
Change in Practical Skills Competence Score
Practical self-care skills assessed using a validated Observational Checklist (score range 0-50). Higher scores indicate greater competence.
Measured: Baseline, immediately post-intervention, and at 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start30 Dec 2025
- Primary completion30 Apr 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Permanent PacemakerStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to either the structured empowerment program (intervention) or standard care (control) in a non-equivalent control-group design.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Mohamed Mahmoud Afify, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743346
- Sponsor's protocol ID
- 817-10-2025
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamel WNS, Assaf ARA, Shehata AM, Afify NMM. 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. BMC Nurs. 2026 Oct 3;25(1):917. doi: 10.1186/s12912-026-05368-3.
PubMed 42829445
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07743346
- Acronym / sponsor ID
- 817-10-2025
- Conditions
- Permanent Pacemaker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 3 Aug 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 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to either the structured empowerment program (intervention) or standard care (control) in a non-equivalent control-group design.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Participants received standard hospital care only, without the structured empowerment program. |
| Intervention Group | Experimental | Behavioral: Structured Nurse-Led Empowerment ProgramParticipants received the structured nurse-led empowerment program, consisting of three individual teaching sessions with illustrated booklets and demonstration/return-demonstration, delivered within the first week after pacemaker implantation, in addition to standard hospital care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- First-time permanent pacemaker implantation
- Admission to the cardiology department
- Willingness to provide written informed consent
Key exclusion criteria (2 listed)
- Documented psychiatric or cognitive disorders
- Inability to cooperate with the protocol
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 |
|---|---|---|
| Structured Nurse-Led Empowerment ProgramThree 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. | Behavioural | Intervention Group |
| Structured Nurse-Led Empowerment ProgramThree 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 i | Behavioural | Intervention Group |
Primary outcome
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.
2 secondary outcomes
Title: Change in Self-Care Behaviours Score
Time frame: Baseline, immediately post-intervention, and at 1-month follow-up
Change in Practical Skills Competence Score
Time frame: Baseline, immediately post-intervention, and at 1-month follow-up
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 3 Aug 2026.
- Derived from this study: PubMed 42829445Kamel WNS, Assaf ARA, Shehata AM, Afify NMM. 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. BMC Nurs. 2026 Oct 3;25(1):917. doi: 10.1186/s12912-026-05368-3.
- Individual participant dataSharing planned: No
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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 Structured Nurse-Led Empowerment Program in people with Permanent Pacemaker, run by Kafrelsheikh University at 1 site in Egypt.
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 4 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 3 Aug 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 Egypt. 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?
Change in Patient Knowledge Score (time frame: Baseline, immediately post-intervention, and at 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07743346, which also lists 1 linked publication.
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 3 Aug 2026.