The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05883514

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker DDD	Behavioral: Motivational interviewing	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

The Feasibility of Motivational Interviewing on Emotional Intelligence, Dispositional Optimism, and Adherence to Care Practices Among Patients With Permanent Pacemaker

Actual Study Start Date :

Apr 15, 2023

Anticipated Primary Completion Date :

Aug 15, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Group one (study group, 35 patients): received the Motivational interviewing 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.
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.

Arm

Intervention/Treatment

Experimental: Intervention group

Group one (study group, 35 patients): received the Motivational interviewing 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.

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.

Outcome Measures

Primary Outcome Measures

Adherence with Pacemaker Care Practices [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Nursing, Alexandria university	Alexandria		Egypt

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahmoud Khedr, Lecturer, Alexandria University

ClinicalTrials.gov Identifier:

NCT05883514

Other Study ID Numbers:

0001

First Posted:

Jun 1, 2023

Last Update Posted:

Jun 1, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 1, 2023