The Effect of Education Given to Patients with Atrial Fibrillation on Anxiety Levels

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation New Onset; Atrial Fibrillation (AF)
• Intervention / Treatment: Other: educational app

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34000
    • Uskudar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• 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

Exclusion criteria:

* Using any psychotropic medication (antidepressant, anxiolytic, antipsychotic)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: training group; 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.	Other: educational app; 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.
No Intervention: control group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 2-3 hours after training

Collaborators and Investigators

• Sponsor: Kübra Kocaispir
• Investigators: Study Director: Sebahat B Ateş, Uskudar University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 23, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Anxiety; Patient education
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 61351342/020-192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPDs can result in a broadcast
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No