NCT05883514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 20, 2023

Last Update Submit

May 30, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with severe mental problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Alexandria university

Alexandria, Egypt

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 20, 2023

First Posted

June 1, 2023

Study Start

April 15, 2023

Primary Completion

August 15, 2023

Study Completion

September 15, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations