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NCT Number: NCT06204601

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacer GOK UGUR, Ordu, Altınordu, Turkey (Türkiye)

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About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education According to Meleis' Transitional Theory to Patients With Pacemaker

Other

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

Primary outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: month 1

    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.

Secondary outcomes

  1. Self-Efficacy Scale in Chronic Diseases

    Time frame: month 1

    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

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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