Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Emotional Freedom Technique (EFT) Effect on Nurses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04393077
Recruitment Status : Completed
First Posted : May 19, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Demet İnangil, PhD, Istanbul Saglik Bilimleri University

Brief 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.


Condition or disease Intervention/treatment Phase
Stress Anxiety Burnout, Caregiver Behavioral: Emotional Freedom Technique Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Emotional Freedom Technique (EFT) Effect on Nurses' Stress, Anxiety and Burnout Levels During the COVID-19 Pandemic Process: A Randomized Controlled Study
Actual Study Start Date : May 10, 2020
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.
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
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.




Primary Outcome Measures :
  1. The subjective units of distress scale [ Time Frame: Immediately after EFT implementation ]
    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.

  2. The State Anxiety [ Time Frame: Immediately after EFT implementation ]
    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.

  3. Burnout [ Time Frame: Immediately after EFT implementation ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Not taking any courses about coping with anxiety and stress,
  • Volunteering to participate in the study.

Exclusion Criteria:

  • Having any psychiatric diagnoses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393077


Locations
Layout table for location information
Turkey
Medeniyet University
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Saglik Bilimleri University
Investigators
Layout table for investigator information
Study Chair: Berna Dinçer Istanbul Medeniyet University
Publications:
Layout table for additonal information
Responsible Party: Demet İnangil, PhD, Assistant Professor, Istanbul Saglik Bilimleri University
ClinicalTrials.gov Identifier: NCT04393077    
Other Study ID Numbers: 2020\0192
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Demet İnangil, PhD, Istanbul Saglik Bilimleri University:
COVID-19
Emotional Freedom Technique
Additional relevant MeSH terms:
Layout table for MeSH terms
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms