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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05883514
Other study ID # 0001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2023
Est. completion date September 15, 2023

Study information

Verified date May 2023
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date September 15, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational interviewing
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.

Locations

Country Name City State
Egypt Faculty of Nursing, Alexandria university Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . 2 months
Primary 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). 2 months
Primary 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). 2 months
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