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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04393077
Other study ID # 2020\0192
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 10, 2020
Est. completion date May 20, 2020

Study information

Verified date November 2020
Source Istanbul Saglik Bilimleri University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Infectious disease outbreaks have a psychological effect on the general population, and especially on health workers. Nurses who care for COVID-19 patients feel negative emotions, fear, and anxiety due to fatigue, discomfort, and helplessness due to high-intensity work. Objective: The study aims to evaluate the effect of EFT in the prevention of stress, anxiety, and burnout of nurses who have an important position in the fight against COVID-19. Design: Randomized controlled trial. Setting: COVID-19 department of a university hospital in Istanbul Province, Turkey. Participants: The sample of the study consisted of nurses working on 80 COVID-19 cases. Methods: The investigators will recruit nurses who care for the patient infected with COVID-19 randomly allocated them to the intervention (n = 40) and control (n = 40) groups. EFT will apply to the experimental group with online access. Data will collect using the Introductory Characteristics Form, the Subjective Discomfort Unit Scale, the State-Trait Anxiety Inventory, and the Burnout Scale.


Description:

With the onset of the COVID-19 epidemic, healthcare workers have assumed important responsibilities in the control, prevention, care, and treatment of its spread. In this period, they provided the necessary health practices for suspicious or confirmed COVID-19 patients in the front lines and under harsh conditions, which are generally long and tiring. It is clear that infectious disease outbreaks have a psychological effect on the general population, and especially on health workers. The social distance required to prevent outbreaks is a key factor in disease management while causing social and psychological effects. 2.1. Design A randomized controlled experimental research design. The study complied with the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) checklist. 2.2. Participants This study will conduct with nurses working in a university hospital located in Istanbul between May 2020 and June 2020, working in the care of COVID-19 patients. 2.5. Measures The data will be collected with the Introductory Characteristics Form, the positive units of distress scale, the State-Trait Anxiety Inventory, and the Burnout Inventory. The investigators created our data collection forms using Survey Monkey, which provides electronic self-access and prevents data from multiple entries from the same person, making it easier to collect and track data. Confidentiality will be guaranteed by completely disabling electronic and IP address records to obtain anonymous replies.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 20, 2020
Est. primary completion date May 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Not taking any courses about coping with anxiety and stress, - Volunteering to participate in the study. Exclusion Criteria: - Having any psychiatric diagnoses

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Emotional Freedom Technique
EFT application was started by showing the meridian points to the participants through the picture. It was advised that these points should be clicked with the index finger and middle finger without hurting, but with certain strokes, and it was ensured that they understood the regions by showing and applying them. Then, the following basic steps, which should be followed by the EFT session (four in total lasting 20 minutes), were carried out in succession with the researcher.

Locations

Country Name City State
Turkey Medeniyet University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Saglik Bilimleri University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hersch RK, Cook RF, Deitz DK, Kaplan S, Hughes D, Friesen MA, Vezina M. Reducing nurses' stress: A randomized controlled trial of a web-based stress management program for nurses. Appl Nurs Res. 2016 Nov;32:18-25. doi: 10.1016/j.apnr.2016.04.003. Epub 2016 Apr 9. — View Citation

Sun N, Wei L, Shi S, Jiao D, Song R, Ma L, Wang H, Wang C, Wang Z, You Y, Liu S, Wang H. A qualitative study on the psychological experience of caregivers of COVID-19 patients. Am J Infect Control. 2020 Jun;48(6):592-598. doi: 10.1016/j.ajic.2020.03.018. Epub 2020 Apr 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The subjective units of distress scale The cognitive element of EFT involves self-rating of distress severity and pairing of an abbreviated exposure statement and a self-acceptance statement. The severity of distress was evaluated by subjects on an 11-point Likert scale. 0 corresponds to absolutely no distress, while 10 corresponds to the maximum possible distress. This was considered as the subjective units of distress scale (SUD) and provides clinicians and patients with the measurement of the severity of symptoms experienced by the latter in addition to a repeated measure by which the progress can be evaluated. Immediately after EFT implementation
Primary The State Anxiety The State-Trait Anxiety Inventory includes two separate scales with a total of 40 items. This study employed the State Anxiety Scale. Its validity and reliability in Turkish were confirmed by Öner and Lecompte. The scale consists of 20 questions and anxiety questions. To obtain the anxiety scale, to state how the person feels at any time and under any circumstances, answers were requested taking into account the feelings related to the situation. Immediately after EFT implementation
Primary Burnout The scale was created to measure the professional burnout levels of individuals. Adaptation studies in Turkish were carried out by Çapri in (2006) This 7-point Likert type scale consists of 21 items, scoring between 1 (never) and 7 (always), while 4 items (3, 6, 19, 20) of the scale are scored in reverse. While evaluating the scale scores, the increase in the score obtained indicates that burnout increases and the decrease in score indicates that burnout decreases. Immediately after EFT implementation
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