NCT04910516

Brief Summary

It has been planned to determine the effect of EFT, which effectiveness has been determined by the studies, on the covid-19 fear and anxiety experienced by the nurses working in the emergency department. The study was designed as a randomized controlled study with pre-test and post-test control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

May 27, 2021

Last Update Submit

June 1, 2021

Conditions

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.

    After 7 days of EFT

  • State-Trait Anxiety Inventory

    This scale consists of a total of forty items; the "State Anxiety Scale" consisting of twenty items and the "Trait Anxiety Scale" consisting of twenty items. There are two types of expressions in the scales: direct and reversed. Direct expressions express negative emotions, and reversed expressions express positive emotions. There are ten (1, 2, 5, 8, 10, 11, 15, 16, 19, and 20th) reversed statements on the state anxiety scale. On the trait anxiety scale, there are seven (1, 6, 7, 10, 13, 16, 19th items) reversed. The total score value obtained from each scale is between minimum 20 and maximum 80. The total score of the reverse expressions is subtracted from the total score obtained for direct expressions. A predetermined and constant value is added to this number. This is 50 for state anxiety and 35 for trait anxiety. The most recent value is the individual's anxiety score. A high score indicates a high anxiety level, a small score indicates a low anxiety level.

    After 7 days of EFT

  • Coronavirus-19 Fear Scale

    This scale consists of 7 items in total and is collected in one dimension.There are no reverse questions in the scale and are answered in a five-point Likert type (1 = Strongly disagree, 5 = Strongly agree).The minimum score that can be obtained for each question on the scale is 1, and the maximum score is 5. The total score that can be obtained from the scale varies between 7-35. As the total score on the scale increases, the fear of coronavirus increases

    After 7 days of EFT

Study Arms (2)

Control Group

NO INTERVENTION

The nurses in the control group were informed about the purpose of working in a quiet room. STAI-D, STAI-S, SUD, P19-S scales were filled face-to-face by the investigator after their informed consent was obtained. The scales were filled again by the researcher after a break of 7 (seven) days.

Experiment Group

EXPERIMENTAL

In order to avoid bias in the intervention applied in our study, the experimental group was started after the control group was finished. The participants were informed about the purpose of working face-to-face in a quiet room so that EFT, which will be applied online for 7 (seven) days by the researcher, can be applied effectively and accurately. STAI-D, STAI-S, SUD, P19-S scales were completed after their consent was obtained. The researcher, who has the EFT certificate, first showed the application steps on himself with the guidance of the EFT guideline, and ensured that the application steps were applied again simultaneously on both himself and the participant. After this application, it was provided to make EFT online for 7 (seven) days. STAI-D, STAI-S, SUD, P19-S scales were filled in after the last EFT application.

Behavioral: Emotional Freedom Techniques (EFT)

Interventions

It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage fo

Experiment Group

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,
  • The absence of infection, wound, scar in the tapping area

You may not qualify if:

  • Having any psychiatric diagnoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Kadikoy, 34722, 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
  • Clond M. Emotional Freedom Techniques for Anxiety: A Systematic Review With Meta-analysis. J Nerv Ment Dis. 2016 May;204(5):388-95. doi: 10.1097/NMD.0000000000000483.

    PMID: 26894319BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: It was aimed to measure the anxiety and covid-19 fears of the Emergency Department nurses. The number of people to be included in the study was determined to be working with 44 nurses in the experimental group and 44 nurses in the control group in the calculation made for a maximum 5% type I error and at least 80% power. The determination of the sample size and the creation of the Randomization Table was calculated using the "www.e-picos.com", NY New York, program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 2, 2021

Study Start

April 10, 2021

Primary Completion

May 25, 2021

Study Completion

July 1, 2021

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations