Atrial Fibrillation (AF)NCT06793319
The Effect of Education Given to Patients with Atrial Fibrillation on Anxiety Levels
A study testing educational app in people with Atrial Fibrillation (AF) and Atrial Fibrillation New Onset, run by Kübra Kocaispir at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of a structured training program on state anxiety levels in patients diagnosed with Atrial Fibrillation (AF). AF is a chronic heart rhythm disorder that negatively affects patients' quality of life with both physical and psychological symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 months
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation New Onset
- What is being tested?
- educational app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 31 Oct 2024
- 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 18 to 65 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newly diagnosed with AF,
- Able to speak and understand Turkish,
- Does not have a physical or psychological disorder that would cause communication problems,
- Patients between the ages of 18 and 65 who are oriented to place and time, -Agreeing to participate in the study
Who cannot join
- Using any psychotropic medication (antidepressant, anxiolytic, antipsychotic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atriyal Fibrilasyonu Olan Hastalara Verilen Eğitimin Anksiyete Düzeyleri Üzerine Etkisi
This study aims to evaluate the effect of a structured training program on state anxiety levels in patients diagnosed with Atrial Fibrillation (AF). AF is a chronic heart rhythm disorder that negatively affects patients' quality of life with both physical and psychological symptoms. Lack of information and uncertainty in AF patients cause increased anxiety levels, making compliance with treatment difficult. This study aims to determine whether an educational intervention for AF patients can reduce their anxiety levels and increase their awareness of the disease. This is a randomized controlled trial. A two-session individual training program containing detailed information about AF will be applied to the training group and no training will be given to the control group. Data will be collected through a personal information form and the Situationality Anxiety Inventory (STAI).
Hypotheses of the Research H0: Training regarding Atrial Fibrillation has no effect on the anxiety level of patients.
H1: Education regarding Atrial Fibrillation reduces the anxiety level of patients.
- Being tested
- educational app
- Keywords
- Anxiety, Atrial Fibrillation, Patient education
- Medical subject headings
- Atrial Fibrillation, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational appOther
State Anxiety Inventory was filled out before the training. Atrial Fibrillation training was provided. After the training, the Situationality Anxiety Inventory was filled out again. It was aimed to evaluate the effect of education on anxiety.
| Study group | Role | What they receive |
|---|---|---|
| training group | Experimental | Written and verbal consent of the training group patients was obtained using the Patient Information and Consent Form. The patients in the training group first filled out the Personal Information Form and Situationality Anxiety Inventory (STAI 1) before the training. Atrial Fibrillation training was given one-on-one in the patient's room. The training was explained using clear, simple language that patients could understand. Patients were encouraged to ask questions. They were asked about the parts they did not understand. It was done by answering the patients' questions. The training was held in 2 sessions in one day. It was planned as one hour before noon and one hour in the afternoon. After the Atrial Fibrillation training given to the patients, the Situationality Anxiety Inventory (STAI 1) was filled out again to evaluate the anxiety level. Receives: Other: educational app |
| control group | No intervention | Written and verbal consent of the patients in the control group was obtained using the Patient Information and Consent Form. Personal Information Form and Situationality Anxiety Inventory (STAI 1) were filled out. No training was given. At the end of the follow-up period, the Situationality Anxiety Inventory (STAI 1) was filled out again. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Levels of Patients Given Atrial Fibrillation Training
This study was conducted in a randomized controlled manner. It was done with 60 patients. 30 patients were assigned to the training group and 30 patients to the control group. There is a training and control group. Groups will fill out a personal information form and the State Anxiety Inventory. Atrial fibrillation training was given to the training group and the state anxiety inventory (STAI 1) was filled out again. The control group was not given any training and had a state anxiety inventory filled out. The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean and standard deviation were used as descriptive statistical methods in the evaluation of the data. Differences between the proportions of categorical variables in independent groups were analyzed with Chi-Square tests. Kurtosis and Skewness values were examined to determine whether the research variables showed normal distribution
Measured: Within 2-3 hours after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Jul 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a study that does not involve drugs or biological products. It was examined how the education given to patients affected anxiety. The operating model is parallel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kübra Kocaispir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kübra Kocaispir, Uskudar University
- Investigators
- Sebahat B Ateş, Study director, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793319
- Sponsor's protocol ID
- 61351342/020-192
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPDs can result in a broadcast
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atriyal Fibrilasyonu Olan Hastalara Verilen Eğitimin Anksiyete Düzeyleri Üzerine Etkisi
- ClinicalTrials.gov ID
- NCT06793319
- Acronym / sponsor ID
- 61351342/020-192
- Keywords
- Anxiety, Atrial Fibrillation, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kübra KocaispirUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 27 Jan 2025 (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 aims to evaluate the effect of a structured training program on state anxiety levels in patients diagnosed with Atrial Fibrillation (AF). AF is a chronic heart rhythm disorder that negatively affects patients' quality of life with both physical and psychological symptoms. Lack of information and uncertainty in AF patients cause increased anxiety levels, making compliance with treatment difficult. This study aims to determine whether an educational intervention for AF patients can reduce their anxiety levels and increase their awareness of the disease. This is a randomized controlled trial. A two-session individual training program containing detailed information about AF will be applied to the training group and no training will be given to the control group. Data will be collected through a personal information form and the Situationality Anxiety Inventory (STAI).
Hypotheses of the Research H0: Training regarding Atrial Fibrillation has no effect on the anxiety level of patients.
H1: Education regarding Atrial Fibrillation reduces the anxiety level of patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is a study that does not involve drugs or biological products. It was examined how the education given to patients affected anxiety. The operating model is parallel.
| Arm | Type | Receives |
|---|---|---|
| training group | Experimental | Other: educational appWritten and verbal consent of the training group patients was obtained using the Patient Information and Consent Form. The patients in the training group first filled out the Personal Information Form and Situationality Anxiety Inventory (STAI 1) before the training. Atrial Fibrillation training was given one-on-one in the patient's room. The training was explained using clear, simple language that patients could understand. Patients were encouraged to ask questions. They were asked about the parts they did not understand. It was done by answering the patients' questions. The training was held in 2 sessions in one day. It was planned as one hour before noon and one hour in the afternoon. After the Atrial Fibrillation training given to the patients, the Situationality Anxiety Inventory (STAI 1) was filled out again to evaluate the anxiety level. |
| control group | No intervention | –Written and verbal consent of the patients in the control group was obtained using the Patient Information and Consent Form. Personal Information Form and Situationality Anxiety Inventory (STAI 1) were filled out. No training was given. At the end of the follow-up period, the Situationality Anxiety Inventory (STAI 1) was filled out again. |
Who may qualify
- Ages
- 18 to 65 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Newly diagnosed with AF,
- Able to speak and understand Turkish,
- Does not have a physical or psychological disorder that would cause communication problems,
- Patients between the ages of 18 and 65 who are oriented to place and time, -Agreeing to participate in the study
Key exclusion criteria (1 listed)
- Using any psychotropic medication (antidepressant, anxiolytic, antipsychotic)
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 |
|---|---|---|
| educational appState Anxiety Inventory was filled out before the training. Atrial Fibrillation training was provided. After the training, the Situationality Anxiety Inventory was filled out again. It was aimed to evaluate the effect of education on anxiety. | Other | training group |
Primary outcome
Anxiety Levels of Patients Given Atrial Fibrillation Training
Time frame: Within 2-3 hours after training
This study was conducted in a randomized controlled manner. It was done with 60 patients. 30 patients were assigned to the training group and 30 patients to the control group. There is a training and control group. Groups will fill out a personal information form and the State Anxiety Inventory. Atrial fibrillation training was given to the training group and the state anxiety inventory (STAI 1) was filled out again. The control group was not given any training and had a state anxiety inventory filled out. The data obtained in the study were analyzed using the SPSS (Statistical Package for Social Sciences) for Windows 22.0 program. Number, percentage, mean and standard deviation were used as descriptive statistical methods in the evaluation of the data. Differences between the proportions of categorical variables in independent groups were analyzed with Chi-Square tests. Kurtosis and Skewness values were examined to determine whether the research variables showed normal distribution
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 27 Jan 2025.
- Individual participant dataSharing planned: Yes. All collected IPDs can result in a broadcast
Related trials for Atrial Fibrillation (AF)
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
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Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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.
Sebahat B Ateş study director
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational app in people with Atrial Fibrillation (AF) and Atrial Fibrillation New Onset, run by Kübra Kocaispir at 1 site 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 4 inclusion and 1 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 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Anxiety Levels of Patients Given Atrial Fibrillation Training (time frame: Within 2-3 hours after training). 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 27 Jan 2025.