FibromyalgiaEFT-FMSNCT06391268
Emotional Freedom Technique (EFT) on Pain and Stress Levels in Fibromyalgia (FMS)
A study testing Emotional Freedom Technique (EFT) works on cognitive and energetic levels. in people with Fibromyalgia, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The main aim of the study was to investigate self-administered emotional to determine the effect of the freedom technique on pain and stress levels. The sub-objectives of the study are as follows: 1. To determine the effect of self-administration of EFT on pain level. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Emotional Freedom Technique (EFT) works on cognitive and energetic levels.
- 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
- 3 Jan 2022to 13 Oct 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of fibromyalgia
- Can speak and understand Turkish
- Have time and place orientation
- No psychiatric illness,
- No vision and hearing problems.
Who cannot join
- Unstable medical condition
- Non-cooperative individuals
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Buca Seyfi Demirsoy Training and Research Hospital
Izmir
About this study
Official title: "Investigation of the Effect of Self-Applied Emotional Liberation Technique on Pain and Stress Levels in Fibromyalgia Patients"
The main aim of the study was to investigate self-administered emotional to determine the effect of the freedom technique on pain and stress levels.
The sub-objectives of the study are as follows:
- To determine the effect of self-administration of EFT on pain level.
- To determine the effect of self-administered EFT on stress level.
- To determine the effect of EFT self-administration on comfort level.
Read the detailed description
HYPOTHESES OF THE RESEARCH
H 1 : Between the pain levels of patients with and without self-administered EFT there is a difference.
H 2 : There is a difference between the stress levels of patients who apply EFT to themselves and those who do not. there is a difference.
H 3 : Comfort levels of patients with and without self-administered EFT there is a difference.
- Conditions
- Fibromyalgia
- Being tested
- Emotional Freedom Technique (EFT) works on cognitive and energetic levels.
- Keywords
- Fibromyalgia,, Emotional free technique, pain, stress, comfort
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Freedom Technique (EFT) works on cognitive and energetic levels.Behavioural
Also called Emotional freedom technique (EFT) for fibromyalgia
Emotional Freedom Technique (EFT) works on cognitive and energetic levels.
| Study group | Role | What they receive |
|---|---|---|
| The group to whichEmotional freedom technique (EFT) EFT was applied by the researcher | Experimental | Emotional Freedom Technique (EFT) works on cognitive and energetic levels. While ensuring that the individual is conscious and aware of a disturbing symptom or discomfort, selected acupuncture points are touched at the same time, creating a cognitive transition and energetic release.
1-The group to which EFT was applied by the researcher Receives: Behavioral: Emotional Freedom Technique (EFT) works on cognitive and energetic levels. |
| Emotional freedom technique (EFT) for fibromyalgia -2-The group that applies EFT to itself | Experimental | Emotional Freedom Technique (EFT) works on cognitive and energetic levels. While ensuring that the individual is conscious and aware of a disturbing symptom or discomfort, selected acupuncture points are touched at the same time, creating a cognitive transition and energetic release.
2-The group that applies EFT to itself Receives: Behavioral: Emotional Freedom Technique (EFT) works on cognitive and energetic levels. |
| Emotional freedom technique (EFT) for fibromyalgia -3-Control group without EFT: | No intervention | 3-Control group without EFT: Pain, problem-stress, comfort and fibromyalgia scales were applied in 3 interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the self-EFT group
Comparison of the group to which EFT was performed by the researcher, Brief Scan for Stress and Problem List to assess stress and problems (Calculated out of 10 points, cut-off point is 4), Brief Pain Invertory to assess pain: The numeric pain scale is evaluated on a scale of 0-10, with "0" representing no pain and "10" representing excruciating pain. Each item is rated on a numerical scale from 0 to 10; "0" means not affected at all, "100" means completely affected).
At the end of the study, pain and stress scores of the two experimental groups (EFT performed by the researcher and self-administered EFT) before and after EFT were analyzed and compared.
Measured: up to 24 weeks
INVESTIGATION OF THE EFFECT OF SELF-APPLIED EMOTIONAL FREEDOM TECHNIQUE ON PAIN AND STRESS LEVELS IN FIBROMYALGIA PATIENTS
It was determined that there was a statistically significant difference in stress thermometer measurements in the researcher-administered EFT, Self-EFT and Control groups according to time (p<0.05). As a result, the hypotheses "H1: EFT application has an effect on the pain level of patients", "H2: EFT application has an effect on the stress level of patients", "H3: EFT application has an effect on the comfort level of patients", "H4: EFT application has an effect on the fibromyalgia level of patients" were accepted. As a result of the research, significant differences were determined in pain, stress and comfort levels in all application groups.
Measured: INVESTIGATION OF THE EFFECT OF SELF-APPLIED EMOTIONAL FREEDOM TECHNIQUE ON PAIN AND STRESS LEVELS IN FIBROMYALGIA PATIENTS
Secondary outcomes (2)
Control grouup
Comparison of the control group with other experimental groups, Comparison of the group to which EFT was performed by the researcher, Brief Scan for Stress and Problem List to assess stress and problems (Calculated out of 10 points, cut-off point is 4), Brief Pain Invertory to assess pain: The numeric pain scale is evaluated on a scale of 0-10, with "0" representing no pain and "10" representing excruciating pain. Each item is rated on a numerical scale from 0 to 10; "0" means not affected at all, "100" means completely affected).
Pain, comfort, fibromyalgia effect scale scores were calculated in the control group and compared with the experimental groups.
Measured: up to 24 weeks
Control grouup
Comparison of the control group with other experimental groups, Comparison of the group to which EFT was performed by the researcher, Brief Scan for Stress and Problem List to assess stress and problems (Calculated out of 10 points, cut-off point is 4), Brief Pain Invertory to assess pain: The numeric pain scale is evaluated on a scale of 0-10, with "0" representing no pain and "10" representing excruciating pain. Each item is rated on a numerical scale from 0 to 10; "0" means not affected at all, "100" means completely affected).
Pain, comfort, fibromyalgia effect scale scores were calculated in the control group and compared with the experimental groups.
Measured: The application areas of the thesis are from non-pharmacological treatments to complementary therapies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start3 Jan 2022
- Primary completion16 Aug 2022
- Study completion13 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- 1. Determination of Subjective Units of Discomfort (SUD) (The researcher scores the distress felt on a scale between zero and ten points). 2. Setup (The general structure of the setup sentence is "Despite this .........., I deeply and completely accept myself.") 3. Clicking the meridian points in sequence 4. Nine Gamut procedure (some eye movements, mumbling and counting while clicking on the Gamut point in the hand).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Buca Seyfi Demirsoy State Hospital
- Responsible party
- Principal investigator, Fatma Çetinkaya, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391268
- Sponsor's protocol ID
- FCetinkaya
- Acronym
- EFT-FMS
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Investigation of the Effect of Self-Applied Emotional Liberation Technique on Pain and Stress Levels in Fibromyalgia Patients"
- ClinicalTrials.gov ID
- NCT06391268
- Acronym / sponsor ID
- EFT-FMS / FCetinkaya
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia,, Emotional free technique, pain, stress, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Buca Seyfi Demirsoy State Hospital
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 13 Oct 2024 (actual)
- First posted
- 30 Apr 2024 (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.
The main aim of the study was to investigate self-administered emotional to determine the effect of the freedom technique on pain and stress levels.
The sub-objectives of the study are as follows:
- To determine the effect of self-administration of EFT on pain level.
- To determine the effect of self-administered EFT on stress level.
- To determine the effect of EFT self-administration on comfort level.
Detailed description
HYPOTHESES OF THE RESEARCH
H 1 : Between the pain levels of patients with and without self-administered EFT there is a difference.
H 2 : There is a difference between the stress levels of patients who apply EFT to themselves and those who do not. there is a difference.
H 3 : Comfort levels of patients with and without self-administered EFT there is a difference.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. Determination of Subjective Units of Discomfort (SUD) (The researcher scores the distress felt on a scale between zero and ten points). 2. Setup (The general structure of the setup sentence is "Despite this .........., I deeply and completely accept myself.") 3. Clicking the meridian points in sequence 4. Nine Gamut procedure (some eye movements, mumbling and counting while clicking on the Gamut point in the hand).
| Arm | Type | Receives |
|---|---|---|
| The group to whichEmotional freedom technique (EFT) EFT was applied by the researcher | Experimental | Behavioral: Emotional Freedom Technique (EFT) works on cognitive and energetic levels.Emotional Freedom Technique (EFT) works on cognitive and energetic levels. While ensuring that the individual is conscious and aware of a disturbing symptom or discomfort, selected acupuncture points are touched at the same time, creating a cognitive transition and energetic release. 1-The group to which EFT was applied by the researcher |
| Emotional freedom technique (EFT) for fibromyalgia -2-The group that applies EFT to itself | Experimental | Behavioral: Emotional Freedom Technique (EFT) works on cognitive and energetic levels.Emotional Freedom Technique (EFT) works on cognitive and energetic levels. While ensuring that the individual is conscious and aware of a disturbing symptom or discomfort, selected acupuncture points are touched at the same time, creating a cognitive transition and energetic release. 2-The group that applies EFT to itself |
| Emotional freedom technique (EFT) for fibromyalgia -3-Control group without EFT: | No intervention | –3-Control group without EFT: Pain, problem-stress, comfort and fibromyalgia scales were applied in 3 interviews. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of fibromyalgia
- Can speak and understand Turkish
- Have time and place orientation
- No psychiatric illness,
- No vision and hearing problems.
Key exclusion criteria (2 listed)
- Unstable medical condition
- Non-cooperative individuals
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 Technique (EFT) works on cognitive and energetic levels.Also: Emotional freedom technique (EFT) for fibromyalgiaEmotional Freedom Technique (EFT) works on cognitive and energetic levels. | Behavioural | Emotional freedom technique (EFT) for fibromyalgia -2-The group that applies EFT to itself, The group to whichEmotional freedom technique (EFT) EFT was applied by the researcher |
Primary outcome
Comparison of the self-EFT group
Time frame: up to 24 weeks
Comparison of the group to which EFT was performed by the researcher, Brief Scan for Stress and Problem List to assess stress and problems (Calculated out of 10 points, cut-off point is 4), Brief Pain Invertory to assess pain: The numeric pain scale is evaluated on a scale of 0-10, with "0" representing no pain and "10" representing excruciating pain. Each item is rated on a numerical scale from 0 to 10; "0" means not affected at all, "100" means completely affected). At the end of the study, pain and stress scores of the two experimental groups (EFT performed by the researcher and self-administered EFT) before and after EFT were analyzed and compared.
INVESTIGATION OF THE EFFECT OF SELF-APPLIED EMOTIONAL FREEDOM TECHNIQUE ON PAIN AND STRESS LEVELS IN FIBROMYALGIA PATIENTS
Time frame: INVESTIGATION OF THE EFFECT OF SELF-APPLIED EMOTIONAL FREEDOM TECHNIQUE ON PAIN AND STRESS LEVELS IN FIBROMYALGIA PATIENTS
It was determined that there was a statistically significant difference in stress thermometer measurements in the researcher-administered EFT, Self-EFT and Control groups according to time (p<0.05). As a result, the hypotheses "H1: EFT application has an effect on the pain level of patients", "H2: EFT application has an effect on the stress level of patients", "H3: EFT application has an effect on the comfort level of patients", "H4: EFT application has an effect on the fibromyalgia level of patients" were accepted. As a result of the research, significant differences were determined in pain, stress and comfort levels in all application groups.
2 secondary outcomes
Control grouup
Time frame: up to 24 weeks
Control grouup
Time frame: The application areas of the thesis are from non-pharmacological treatments to complementary therapies.
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 16 Oct 2024.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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 Technique (EFT) works on cognitive and energetic levels. in people with Fibromyalgia, run by Ege 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 5 inclusion and 2 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 16 Oct 2024. 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?
Comparison of the self-EFT group (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.