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Clinical Trials/NCT06204601
NCT06204601CompletedNot Applicable

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

T.C. ORDU ÜNİVERSİTESİ4 sites in 1 country70 target enrollmentStarted: November 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
4
Primary Endpoint
Hospital Anxiety and Depression Scale

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Participant)

Masking Description

Block randomization

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

  • Self-Efficacy Scale in Chronic Diseases(month 1)

Investigators

Sponsor
T.C. ORDU ÜNİVERSİTESİ
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hacer Gok Ugur

Associate Professor.

T.C. ORDU ÜNİVERSİTESİ

Study Sites (4)

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