Pacemaker DDDNCT05883514
The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker
A study testing Motivational interviewing in people with Pacemaker DDD, run by Alexandria University at 1 site in Egypt.
Trial summary
A cardiac pacemaker is an artificial apparatus that stimulates the myocardium electrically to depolarize, to begin a contraction when the heart's natural pacemaker does not work properly. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Pacemaker DDD
- What is being tested?
- Motivational interviewing
- 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
- 15 Apr 2023to 15 Sep 2023
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with permanent cardiac pacemaker implantation aged from 20 up to 65 years old.
- Both sexes (male \& female).
- Able to communicate verbally.
- Free from psychotic disorders.
- Not scheduled for other surgeries.
- Agree to participate in the current study.
Who cannot join
- Patients with severe mental problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing, Alexandria university
Alexandria
Eman Taha, professor, 01283440749, eman.taha@alexu.edu.eg
About this study
A cardiac pacemaker is an artificial apparatus that stimulates the myocardium electrically to depolarize, to begin a contraction when the heart's natural pacemaker does not work properly. Pacemakers are essential when dysrhythmias or conduction defects compromise the electrical system and the heart's hemodynamic response.
The current status aimed to assess the feasibility of motivational interviewing on emotional intelligence, dispositional optimism, and adherence to care practices among patients with permanent pacemaker.
Read the detailed description
According to the Miller and Rollnick principles, the framework of the motivational interviewing group's sessions was taken from the workbook of the intervention's six motivational interviewing sessions. A researcher recruited participants in groups of 7 patients for six sessions of 60-90 minutes each (two sessions per week). The training sessions covered stress alleviation, appropriate drug usage, quitting smoking, regular physical activity, healthy eating habits, and regular physical activity. Patients in the control group got standard treatment for PPM, including education on proper medication usage, nutrition, exercise, and regular checking.
- Conditions
- Pacemaker DDD
- Being tested
- Motivational interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
According to the Miller and Rollnick principles, the framework of the motivational interviewing group's sessions was taken from the workbook of the intervention's six sessions of motivational interviewing. A researcher recruited participants in groups of 7 patients for six sessions of 60-90 minutes each (two sessions per week). The training sessions covered topics like stress alleviation, appropriate drug usage, quitting smoking, regular physical activity, healthy eating habits, and regular physical activity. Patients in the control group got standard treatment for PPM, including education on proper medication usage, nutrition, and exercise, as well as regular checking.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group one (study group, 35 patients): received the Motivational interviewing intervention. Receives: Behavioral: Motivational interviewing |
| Control group | No intervention | Group two(the control group, 35 patients): will receive routine hospital care such as medication administration, assessment of vital signs, and hygienic care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence with Pacemaker Care Practices
This tool was developed by (Sharma K, 2018) to assess adherence of the patients to pacemaker care practices. It was adapted and translated into Arabic language by the researcher. It included 15 items related to patients' adherence to care practices of pacemaker .
Measured: 2 months
Emotional Intelligence
Emotional Intelligence Scale by (Schutte et al., 1998) to assess the level of emotional intelligence. This scale consists of 33 items, which can be divided into 4 main subscales (perception of emotion, managing own emotions, managing others' emotions, and utilization of emotion).
Measured: 2 months
Dispositional optimism
The original LOT-R is a self-report questionnaire, measuring dispositional optimism and developed by (Scheier, Carver, \& Bridges, 1994). The questionnaire consists of 10 items, of which three positively formulated items (1, 4, and 10), three negatively formulated items (3, 7, and 9), and four "filler" items (2, 5, 6, and 8).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start15 Apr 2023
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
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 Pacemaker DDDStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883514
- Sponsor's protocol ID
- 0001
- Status last verified
- May 2023
- First submitted
- 20 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khedr MA, Ali EA, Sanhoury MI, Hussein RM. The feasibility of motivational interviewing on adherence to care practices, emotional intelligence, and dispositional optimism among patients with permanent pacemakers. Eur J Cardiovasc Nurs. 2024 Jul 19;23(5):497-509. doi: 10.1093/eurjcn/zvad113.
PubMed 38165278
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker
- ClinicalTrials.gov ID
- NCT05883514
- Acronym / sponsor ID
- 0001
- Conditions
- Pacemaker DDD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 1 Jun 2023 (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.
A cardiac pacemaker is an artificial apparatus that stimulates the myocardium electrically to depolarize, to begin a contraction when the heart's natural pacemaker does not work properly. Pacemakers are essential when dysrhythmias or conduction defects compromise the electrical system and the heart's hemodynamic response.
The current status aimed to assess the feasibility of motivational interviewing on emotional intelligence, dispositional optimism, and adherence to care practices among patients with permanent pacemaker.
Detailed description
According to the Miller and Rollnick principles, the framework of the motivational interviewing group's sessions was taken from the workbook of the intervention's six motivational interviewing sessions. A researcher recruited participants in groups of 7 patients for six sessions of 60-90 minutes each (two sessions per week). The training sessions covered stress alleviation, appropriate drug usage, quitting smoking, regular physical activity, healthy eating habits, and regular physical activity. Patients in the control group got standard treatment for PPM, including education on proper medication usage, nutrition, exercise, and regular checking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Motivational interviewingGroup one (study group, 35 patients): received the Motivational interviewing intervention. |
| Control group | No intervention | –Group two(the control group, 35 patients): will receive routine hospital care such as medication administration, assessment of vital signs, and hygienic care. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with permanent cardiac pacemaker implantation aged from 20 up to 65 years old.
- Both sexes (male \& female).
- Able to communicate verbally.
- Free from psychotic disorders.
- Not scheduled for other surgeries.
Key exclusion criteria (1 listed)
- Patients with severe mental problems
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 |
|---|---|---|
| Motivational interviewingAccording to the Miller and Rollnick principles, the framework of the motivational interviewing group's sessions was taken from the workbook of the intervention's six sessions of motivational interviewing. A researcher recruited participants in groups of 7 patients for six sessions of 60-90 minutes each (two sessions per week). The training sessions covered topics like stress alleviation, appropriate drug usage, quitting smoking, regular physical activity, healthy eating habits, and regular physical activity. Patients in the control group got standard treatment for PPM, including education on proper medication usage, nutrition, and exercise, as well as regular checking. | Behavioural | Intervention group |
Primary outcome
Adherence with Pacemaker Care Practices
Time frame: 2 months
This tool was developed by (Sharma K, 2018) to assess adherence of the patients to pacemaker care practices. It was adapted and translated into Arabic language by the researcher. It included 15 items related to patients' adherence to care practices of pacemaker .
Emotional Intelligence
Time frame: 2 months
Emotional Intelligence Scale by (Schutte et al., 1998) to assess the level of emotional intelligence. This scale consists of 33 items, which can be divided into 4 main subscales (perception of emotion, managing own emotions, managing others' emotions, and utilization of emotion).
Dispositional optimism
Time frame: 2 months
The original LOT-R is a self-report questionnaire, measuring dispositional optimism and developed by (Scheier, Carver, \& Bridges, 1994). The questionnaire consists of 10 items, of which three positively formulated items (1, 4, and 10), three negatively formulated items (3, 7, and 9), and four "filler" items (2, 5, 6, and 8).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 38165278Khedr MA, Ali EA, Sanhoury MI, Hussein RM. The feasibility of motivational interviewing on adherence to care practices, emotional intelligence, and dispositional optimism among patients with permanent pacemakers. Eur J Cardiovasc Nurs. 2024 Jul 19;23(5):497-509. doi: 10.1093/eurjcn/zvad113.
- Individual participant dataSharing planned: No
Related trials for Pacemaker DDD
RecruitingObservational study
Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Atrial Fibrillation, Pacemaker Ddd
RecruitingObservational study
Non-Invasive Method for Evaluation of Cardiac Resynchronization Therapy
Heart Failure, Pacemaker DDD
RecruitingObservational study
Left Bundle Branch Area Mapping for Conduction System Pacing
Left Bundle-Branch Block, Pacemaker DDD
Active, not recruitingPhase 4
The Leadless AV Versus DDD Pacing Study
Cardiac Pacemaker, Arrhythmias, Cardiac
Active, not recruiting
Danish Randomized Trial on Leadless vs Transvenous Pacing
AV Block
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Pacemaker DDD, run by Alexandria 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence with Pacemaker Care Practices (time frame: 2 months). The study lists 3 primary outcomes in all. 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 NCT05883514, 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 1 Jun 2023.