The Effect Of Education Given According to Meleıs' Transitional Theory to Patients With Pacemaker

The Effect Of Education Given According to Meleıs' Transitional Theory on The Level of Self-Effectiveness With Anxiety and Depression to Patients With Pacemaker: A Single-Blind Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Educational Activities
• Intervention / Treatment: Other: Education According to Meleis' Transitional Theory to Patients With Pacemaker

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ordu, Turkey, 52200
    • Hacer GÖK UĞUR
  • Altınordu
    • Ordu, Altınordu, Turkey, 52000
      • Hacer GÖK UĞUR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Experimental group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: T.C. ORDU ÜNİVERSİTESİ
• Investigators: Principal Investigator: Hacer GÖK UĞUR, Asos.Prof., Ordu Univercity

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Nursing; Pacemaker,; Meleis Transition Theory,; Education,; Self-Efficacy,; Anxiety, Depression,
• Other Study ID Numbers: 2Ordu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No