Educational ActivitiesNCT06204601
The Effect Of Education Given According to Meleıs' Transitional Theory to Patients With Pacemaker
A study testing Education According to Meleis' Transitional Theory to Patients With Pacemaker in people with Educational Activities, run by Ordu University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Educational Activities
- What is being tested?
- Education According to Meleis' Transitional Theory to Patients With Pacemaker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Nov 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacer GOK UGUR
Ordu, Altınordu, 52000
Hacer GÖK UĞUR
Ordu, 52200
About this study
Official 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
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.
Read the 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.
- Conditions
- Educational Activities
- Being tested
- Education According to Meleis' Transitional Theory to Patients With Pacemaker
- Keywords
- Pacemaker,, Meleis Transition Theory,, Education,, Self-Efficacy,, Anxiety, Depression,, Nursing
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education According to Meleis' Transitional Theory to Patients With PacemakerOther
Patients in the experimental group will be trained according to Meleis's Transition Theory.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group Receives: Other: Education According to Meleis' Transitional Theory to Patients With Pacemaker |
| Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: month 1
Secondary outcomes (1)
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
Measured: month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start10 Nov 2022
- Primary completion10 Oct 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ActivitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trial model with pretest posttest control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Gok Ugur, Ordu University
- Investigators
- Hacer GÖK UĞUR, Asos.Prof., Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204601
- Sponsor's protocol ID
- 2Ordu
- Status last verified
- Jan 2024
- First submitted
- 1 Nov 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06204601
- Acronym / sponsor ID
- 2Ordu
- Conditions
- Educational Activities
- Keywords
- Pacemaker,, Meleis Transition Theory,, Education,, Self-Efficacy,, Anxiety, Depression,, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Trial model with pretest posttest control group
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Education According to Meleis' Transitional Theory to Patients With PacemakerExperimental group |
| Control group | No intervention | –Control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education According to Meleis' Transitional Theory to Patients With PacemakerPatients in the experimental group will be trained according to Meleis's Transition Theory. | Other | Experimental group |
Primary outcome
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.
1 secondary outcome
Self-Efficacy Scale in Chronic Diseases
Time frame: month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hacer GÖK UĞUR, Asos.Prof. principal investigator
Ordu University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education According to Meleis' Transitional Theory to Patients With Pacemaker in people with Educational Activities, run by Ordu University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (time frame: month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.