Anxiety, Covid-19 FearEFTNCT04910516
Emotional Freedom Technique (EFT) Effect on Nurses
A study testing Emotional Freedom Techniques (EFT) in people with Anxiety, Covid-19 Fear, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Covid-19 Fear
- What is being tested?
- Emotional Freedom Techniques (EFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2021to 1 Jul 2021
- 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,
- The absence of infection, wound, scar in the tapping area
Who cannot join
- Having any psychiatric diagnoses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of "Emotional Freedom Technique" on Covid-19 Reasoned Fear and Anxiety Levels of Nurses Working in the Emergency Department
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.
Read the detailed description
Although it has been a year since WHO declared an emergency, the covid-19 virus has mutated and the number of cases has started to increase again as of February 2021. The emergence of uncertainties in the risk of transmission of the mutant virus together with the simultaneous management of both the care process of pandemic patients and the patients who apply for emergency care and treatment in the emergency services increases the fear of the virus. The feeling of fear causes the person to become distracted and increase anxiety by focusing on the fact that he or she is under the threat of the virus. Recently, non-pharmacological techniques are widely used to reduce anxiety and fear. One of them is EFT. It is to examine the effects of EFT, which effectiveness has been determined with the studies carried out in this challenging process, on the covid-19 fear and high anxiety of emergency room nurses.
- Conditions
- Anxiety, Covid-19 Fear
- Being tested
- Emotional Freedom Techniques (EFT)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom Techniques (EFT)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Emotional Freedom Techniques (EFT) |
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: 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.
Measured: 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
Measured: After 7 days of EFT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start10 Apr 2021
- Primary completion25 May 2021
- Study completion1 Jul 2021 (estimated)
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 Anxiety, Covid-19 FearStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulsah okut, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910516
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/120
- Acronym
- EFT
- Status last verified
- May 2021
- First submitted
- 27 May 2021
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 32334904Clond 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.
PubMed 26894319
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of "Emotional Freedom Technique" on Covid-19 Reasoned Fear and Anxiety Levels of Nurses Working in the Emergency Department
- ClinicalTrials.gov ID
- NCT04910516
- Acronym / sponsor ID
- EFT / B.10.1.TKH.4.34.H.GP.0.01/120
- Conditions
- Anxiety, Covid-19 Fear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 2 Jun 2021 (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.
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.
Detailed description
Although it has been a year since WHO declared an emergency, the covid-19 virus has mutated and the number of cases has started to increase again as of February 2021. The emergence of uncertainties in the risk of transmission of the mutant virus together with the simultaneous management of both the care process of pandemic patients and the patients who apply for emergency care and treatment in the emergency services increases the fear of the virus. The feeling of fear causes the person to become distracted and increase anxiety by focusing on the fact that he or she is under the threat of the virus. Recently, non-pharmacological techniques are widely used to reduce anxiety and fear. One of them is EFT. It is to examine the effects of EFT, which effectiveness has been determined with the studies carried out in this challenging process, on the covid-19 fear and high anxiety of emergency room nurses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Emotional Freedom Techniques (EFT)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
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 Techniques (EFT)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 | Behavioural | Experiment Group |
Primary outcome
The subjective units of distress scale
Time frame: After 7 days of EFT
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.
State-Trait Anxiety Inventory
Time frame: After 7 days of EFT
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.
Coronavirus-19 Fear Scale
Time frame: After 7 days of EFT
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- 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 26894319Clond 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.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Techniques (EFT) in people with Anxiety, Covid-19 Fear, run by Marmara 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 3 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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?
Results are not available in the source record.
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: After 7 days of EFT). 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 NCT04910516, 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 2 Jun 2021.