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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06204601
Other study ID # 2Ordu
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 10, 2022
Est. completion date December 15, 2023

Study information

Verified date January 2024
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. Hypotheses of the Research H01: Training given to patients with pacemaker implantation according to Meleis's Transition Theory does not affect the anxiety and depression levels of the patients. H11: Training given according to Meleis's Transition Theory to patients with pacemaker implants reduces the anxiety and depression levels of patients. H02: Training given to patients with pacemaker implantation according to Meleis's Transition Theory does not affect the self-efficacy level of the patients. H12: Training given to patients with pacemakers according to Meleis's Transition Theory increases the self-efficacy level of the patients.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 15, 2023
Est. primary completion date October 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education According to Meleis' Transitional Theory to Patients With Pacemaker
Patients in the experimental group will be trained according to Meleis's Transition Theory.

Locations

Country Name City State
Turkey Hacer GOK UGUR Ordu Altinordu
Turkey Hacer GÖK UGUR Ordu

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Self-Efficacy Scale in Chronic Diseases The scale was developed by Lorig et al. (1996) in 1996 to measure the self-efficacy perceptions of individuals with chronic diseases and was adapted into Turkish by Ceyhan and Ünsal (2017). The scale generally consists of three main concepts and a total of 10 sub-dimensions. In order to realize the first concept, "Self-management behaviors", under the heading of PE; The sub-dimensions include doing regular sports, getting information about the disease, getting help from society, family and friends, and communicating with the doctor. The scale is answered in Likert type, increasing from 0 to 10, which determines the perception of PE. The number 0 on the scale represe month 1
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