NCT04393077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

5 days

First QC Date

May 11, 2020

Last Update Submit

November 20, 2020

Conditions

Keywords

COVID-19Emotional Freedom Technique

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Having any psychiatric diagnoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 32334904BACKGROUND
  • 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.

    PMID: 27969025BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersCaregiver BurdenCOVID-19

Condition Hierarchy (Ancestors)

Mental DisordersStress, PsychologicalBehavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Berna Dinçer

    Istanbul Medeniyet University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 19, 2020

Study Start

May 10, 2020

Primary Completion

May 15, 2020

Study Completion

May 20, 2020

Last Updated

November 24, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations