- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05883514
The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alexandria, Egypt
- Recruiting
- Faculty of Nursing, Alexandria University
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Contact:
- Eman Taha, professor
- Phone Number: 01283440749
- Email: eman.taha@alexu.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with severe mental problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
Group one (study group, 35 patients): received the Motivational interviewing intervention.
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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.
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No Intervention: Control group
Group two(the control group, 35 patients): will receive routine hospital care such as medication administration, assessment of vital signs, and hygienic care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence with Pacemaker Care Practices
Time Frame: 2 months
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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 .
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2 months
|
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Emotional Intelligence
Time Frame: 2 months
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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).
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2 months
|
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Dispositional optimism
Time Frame: 2 months
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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).
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2 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0001 (Researcher)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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