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

NCT ID: NCT06793319

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-10-31

Brief 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. 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.

Conditions

Atrial Fibrillation (AF); Atrial Fibrillation New Onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

educational app

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 65 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kübra Kocaispir

OTHER

Sponsor Role: lead

Responsible Party

Kübra Kocaispir

Intensive Care Nurse

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sebahat B Ateş

Role: STUDY_DIRECTOR

Uskudar University

Locations

Uskudar University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

61351342/020-192

Identifier Type: -

Identifier Source: org_study_id