The Effect Of Education Given According to Meleıs' Transitional Theory to Patients With Pacemaker
1 other identifier
interventional
70
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2023
CompletedFirst Submitted
Initial submission to the registry
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedJanuary 12, 2024
January 1, 2024
11 months
November 1, 2023
January 11, 2024
Conditions
Keywords
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
EXPERIMENTALExperimental group
Control group
NO INTERVENTIONControl group
Interventions
Patients in the experimental group will be trained according to Meleis's Transition Theory.
Eligibility Criteria
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
- Ordu Universitylead
Study Sites (2)
Hacer GOK UGUR
Ordu, Altınordu, 52000, Turkey (Türkiye)
Hacer GÖK UĞUR
Ordu, 52200, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hacer GÖK UĞUR, Asos.Prof.
Ordu Univercity
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
- 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