NCT06008340

Brief Summary

The purpose of the current study was to determine the factors associated with increased levels of anxiety and depression both before and after pacemaker implantation and examine if changes in these symptoms occur during the first postoperative year.

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
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

August 9, 2023

Last Update Submit

August 18, 2023

Conditions

Pacing-Induced Cardiomyopathy

Keywords

AnxietyDepressionPsychological effectDual chamberPacemakerPacing

Outcome Measures

Primary Outcomes (1)

  • Lead position and anxiety/ depression

    Assessment of the effect of the pacemaker lead position in the right ventricle on the psychological aspects of the patients in 1 year follow up period.

    one year

Secondary Outcomes (1)

  • Co morbidities and anxiety / depression

    one year

Interventions

Dual chamber PacemakerDEVICE

Anti bradycardia device implanted in patients with complete heart block, the device has 2 leads, one in the RT atrium and the other in RV. The RV lead positioned either apical or septal

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from heart block and indicated for permanent cardiac pacemaker implantation

You may qualify if:

  • implantation of a dual-chamber pacemaker,
  • the ability to write and read the Arabic language,
  • adequate follow-up and
  • patients older than 18 years who were hospitalized for the first time for the implantation procedure

You may not qualify if:

  • Patients with history of psychiatric illness (mental, emotional, or behavioral disorders),
  • with a serious chronic disease,
  • with implantable cardioverter defibrillator or biventricular pacemaker and
  • patients who had not a stable programming of their device from the implantation.
  • patients less than 18 years old,
  • family and social environment problems prior and subsequent to PM implant,
  • financial problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh university

Kafr ash Shaykh, Egypt

Location

Related Publications (4)

  • Prinzen FW, Peschar M. Relation between the pacing induced sequence of activation and left ventricular pump function in animals. Pacing Clin Electrophysiol. 2002 Apr;25(4 Pt 1):484-98. doi: 10.1046/j.1460-9592.2002.00484.x.

    PMID: 11991375BACKGROUND

  • Tops LF, Schalij MJ, Holman ER, van Erven L, van der Wall EE, Bax JJ. Right ventricular pacing can induce ventricular dyssynchrony in patients with atrial fibrillation after atrioventricular node ablation. J Am Coll Cardiol. 2006 Oct 17;48(8):1642-8. doi: 10.1016/j.jacc.2006.05.072. Epub 2006 Sep 27.

    PMID: 17045901BACKGROUND

  • Polikandrioti M, Tzirogiannis K, Zyga S, Koutelekos I, Vasilopoulos G, Theofilou P, Panoutsopoulos G. Effect of anxiety and depression on the fatigue of patients with a permanent pacemaker. Arch Med Sci Atheroscler Dis. 2018 Feb 5;3:e8-e17. doi: 10.5114/amsad.2018.73231. eCollection 2018.

    PMID: 30775584BACKGROUND

  • Chesney MA, Rosenman RH. Type A behavior: Observations on the past decade. Heart Lung. 1982 Jan-Feb;11(1):12-9. No abstract available.

    PMID: 6915919BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Reda Baiomy, PHD

    Kafrelsheikh University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 23, 2023

Study Start

August 1, 2022

Primary Completion

September 1, 2023

Study Completion

November 1, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

EG(1)