NCT06204601

Brief Summary

This study will be carried out to determine the effect of training given according to Meleis's Transition Theory to patients with pacemaker implantation on anxiety, depression and self-efficacy levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
completed

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

November 10, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

November 1, 2023

Last Update Submit

January 11, 2024

Conditions

Keywords

Pacemaker,Meleis Transition Theory,Education,Self-Efficacy,Anxiety, Depression,Nursing

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale

    The scale was developed by Zigmond and Snaith (1983) to determine the risk of anxiety and depression in patients and was translated into Turkish by Aydemir et al. Adapted from (1997). It consists of a total of 14 questions, odd numbered questions measure anxiety, and even numbered questions measure depression. The scale provides four-point Likert type measurement. In scoring; Items 1, 3, 5, 6, 8, 10, 11 and 13 are in the format 3,2,1,0, 2, 4, 7, 9, 12 and 14. The items are scored as 0,1,2,3. By summing the 1st, 3rd, 5th, 7th, 9th, 11th and 13th items of the anxiety subscale of the scale, the depression subscale; It is calculated by adding the 2nd, 4th, 6th, 8th, 10th, 12th and 14th items. The cut-off score for the anxiety subscale is 10/11 and for the depression subscale is 7/8. Accordingly, areas above these scores are considered at risk.

    month 1

Secondary Outcomes (1)

  • Self-Efficacy Scale in Chronic Diseases

    month 1

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group

Other: Education According to Meleis' Transitional Theory to Patients With Pacemaker

Control group

NO INTERVENTION

Control group

Interventions

Patients in the experimental group will be trained according to Meleis's Transition Theory.

Experimental group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pacemaker implantation,
  • Ages 18 and over,
  • The one who is literate,
  • Open to communication and collaboration,
  • Patients who volunteer to participate in the study will be included in the study.

You may not qualify if:

  • Not oriented to person, place and time,
  • Hearing loss,
  • Cannot understand and speak Turkish and
  • Patients who do not want to continue the study will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hacer GOK UGUR

Ordu, Altınordu, 52000, Turkey (Türkiye)

Location

Hacer GÖK UĞUR

Ordu, 52200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Hacer GÖK UĞUR, Asos.Prof.

    Ordu Univercity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Block randomization
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Trial model with pretest posttest control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor.

Study Record Dates

First Submitted

November 1, 2023

First Posted

January 12, 2024

Study Start

November 10, 2022

Primary Completion

October 10, 2023

Study Completion

December 15, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations