- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04393077
Emotional Freedom Technique (EFT) Effect on Nurses
Emotional Freedom Technique (EFT) Effect on Nurses' Stress, Anxiety and Burnout Levels During the COVID-19 Pandemic Process: A Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- MEDENIYET UNIVERSITY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
Participants will complete the pre-tests of the introductory features form, SUD, STAI-I, and burnout scales sent via Survey Monkey.
The participants (n=40) will be given 15 minutes of free time and asked to be in a position where the individuals were comfortable, in the quietest and most tranquil environment possible.
At the end of this period, post-test SUD, STAI-I, and burnout scales will be sent to the participants and they will be asked to fill in the scores.
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EXPERIMENTAL: Intervention
Firstly, people in the entire group fill out the introductory features form on the online questionnaire form.
The time of the meeting will be determined by collaborating with the participants in the experimental group.
During the interview, they will be asked to be in a position that was comfortable for the individuals, in the quietest and calm environment possible.
At the beginning of the meeting, they will be asked to fill in the pre-test SUD, STAI-I, and burnout scales sent via SurveyMonkey.
Then, the EFT session (20 minutes) will be conducted once mutually with the researcher, who is an expert in their field.
At the end of the session, they will be filled the post-test SUD, STAI-I and burnout scales
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The subjective units of distress scale
Time Frame: Immediately after EFT implementation
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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.
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Immediately after EFT implementation
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The State Anxiety
Time Frame: Immediately after EFT implementation
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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.
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Immediately after EFT implementation
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Burnout
Time Frame: Immediately after EFT implementation
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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.
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Immediately after EFT implementation
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Collaborators and Investigators
Investigators
- Study Chair: Berna Dinçer, İstanbul medeniyet University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020\0192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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