StressNCT04393077
Emotional Freedom Technique (EFT) Effect on Nurses
A study testing Emotional Freedom Technique in people with Stress and Anxiety, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Burnout, Caregiver
- What is being tested?
- Emotional Freedom Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2020to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not taking any courses about coping with anxiety and stress,
- Volunteering to participate in the study.
Who cannot join
- Having any psychiatric diagnoses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stress, Anxiety, Burnout, Caregiver
- Being tested
- Emotional Freedom Technique
- Keywords
- COVID-19, Emotional Freedom Technique
- Medical subject headings
- Anxiety Disorders, Caregiver Burden, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom TechniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Emotional Freedom Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately after EFT implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start10 May 2020
- Primary completion15 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet İnangil, PhD, Istanbul Saglik Bilimleri University
- Investigators
- Berna Dinçer, Study chair, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393077
- Sponsor's protocol ID
- 2020\0192
- Status last verified
- Nov 2020
- First submitted
- 11 May 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32334904Hersch 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.
PubMed 27969025
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Freedom Technique (EFT) Effect on Nurses' Stress, Anxiety and Burnout Levels During the COVID-19 Pandemic Process: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04393077
- Acronym / sponsor ID
- 2020\0192
- Conditions
- Stress, Anxiety, Burnout, Caregiver
- Keywords
- COVID-19, Emotional Freedom Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Emotional Freedom TechniqueFirstly, 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Not taking any courses about coping with anxiety and stress,
- Volunteering to participate in the study.
Key exclusion criteria (1 listed)
- Having any psychiatric diagnoses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotional Freedom TechniqueEFT 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. | Behavioural | Intervention |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Background: PubMed 32334904Sun 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.
- Background: PubMed 27969025Hersch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berna Dinçer study chair
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Freedom Technique in people with Stress and Anxiety, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The subjective units of distress scale (time frame: Immediately after EFT implementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393077, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.