Premenstrual SyndromeNCT06000579
The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students
A study testing EFT in people with Premenstrual Syndrome, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
PMS is one of the common menstrual disorders affecting many young women, and according to epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS symptoms. The prevalence of PMS was different in different countries, with 34% in China , 72% in Turkey , 80% in Pakistan and Jordan. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- EFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 11 Sep 2023
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons with amenorrhea,
- pregnancy,
- menstrual irregularity,
- chronic disease,
- mental disorders,
- psychiatric disorders,
- polycystic ovarian syndrome,
- those who have received training on EFT before and those who have communication problems will not be included in the study.
Who cannot join
- Female students between the ages of 18-25,
- who scored 111 or higher on the Premenstrual Syndrome Scale (PMSS)
- participated in the study voluntarily will be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students: A Randomized Controlled
PMS is one of the common menstrual disorders affecting many young women, and according to epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS symptoms. The prevalence of PMS was different in different countries, with 34% in China , 72% in Turkey , 80% in Pakistan and Jordan. It was detected in the range of 92% in India and 14.3%-74.4% in India. Common premenstrual symptoms include anxiety, lack of concentration, depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea, vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep disturbance, appetite changes. In addition to physical symptoms, studies indicate that individuals reporting PMS experience more stress and anxiety, and their sensitivity to depressive symptoms increases due to hormonal fluctuations. Studies have shown that mindfulness-based cognitive methods are effective in the treatment of mood disorders such as depression. It is thought that modulating many PMS symptoms such as stress and experienced emotional problems through mindfulness-based cognitive methods may be an effective approach for future PMS interventions.
- Conditions
- Premenstrual Syndrome
- Being tested
- EFT
- Keywords
- Emotional Regulation, Premenstrual Syndrome
- Medical subject headings
- Premenstrual Syndrome, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFTOther
Each student will be asked to voluntarily give their phone number and last menstrual cycle date, and the day will be determined for the first session. Then, the first EFT session will be made by the researchers by calling 14 days before the menstruation date. In the 2nd and 3rd sessions, a total of 3 sessions of EFT will be applied face-to-face by the researchers 14 days before menstruation. After each student completes three menstrual cycles, the researchers will meet with the student and PMSS will be applied as a post-test.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | EFT will be applied to individuals with premenstrual syndrome. Receives: Other: EFT |
| Control Group | No intervention | Individuals in the control group will not be interfered with. |
What is being measured
The primary outcome is the main question the study is designed to answer.
premenstrual syndrome and emotional freedom technique
This outcome is assessed with the premenstrual syndrome scale. The lower the score on the scale, the lower the premenstrual syndrome.
Measured: 3 month Wıll Be Followed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start15 Jul 2023
- Primary completion17 Aug 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Collaborators
- EMEL EGE, KAMİLE ALTUNTUĞ, Merve YAZAR
- Responsible party
- Principal investigator, Hafize Dağ Tüzmen, KTO Karatay University
- Investigators
- MERVE YAZAR, Study chair, merve.yazar@karatay.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000579
- Sponsor's protocol ID
- MrvHfz
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Freedom Technique on Premenstrual Syndrome and Pain in University Students: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT06000579
- Acronym / sponsor ID
- MrvHfz
- Conditions
- Premenstrual Syndrome
- Keywords
- Emotional Regulation, Premenstrual Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- EMEL EGE, KAMİLE ALTUNTUĞ, Merve YAZAR
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 21 Aug 2023 (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.
PMS is one of the common menstrual disorders affecting many young women, and according to epidemiological data, approximately 75% of women have PMS symptoms and 3-8% have severe PMS symptoms. The prevalence of PMS was different in different countries, with 34% in China , 72% in Turkey , 80% in Pakistan and Jordan. It was detected in the range of 92% in India and 14.3%-74.4% in India. Common premenstrual symptoms include anxiety, lack of concentration, depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea, vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep disturbance, appetite changes. In addition to physical symptoms, studies indicate that individuals reporting PMS experience more stress and anxiety, and their sensitivity to depressive symptoms increases due to hormonal fluctuations. Studies have shown that mindfulness-based cognitive methods are effective in the treatment of mood disorders such as depression. It is thought that modulating many PMS symptoms such as stress and experienced emotional problems through mindfulness-based cognitive methods may be an effective approach for future PMS interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: EFTEFT will be applied to individuals with premenstrual syndrome. |
| Control Group | No intervention | –Individuals in the control group will not be interfered with. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Persons with amenorrhea,
- pregnancy,
- menstrual irregularity,
- chronic disease,
- mental disorders,
Key exclusion criteria (3 listed)
- Female students between the ages of 18-25,
- who scored 111 or higher on the Premenstrual Syndrome Scale (PMSS)
- participated in the study voluntarily will be included in the study.
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 |
|---|---|---|
| EFTEach student will be asked to voluntarily give their phone number and last menstrual cycle date, and the day will be determined for the first session. Then, the first EFT session will be made by the researchers by calling 14 days before the menstruation date. In the 2nd and 3rd sessions, a total of 3 sessions of EFT will be applied face-to-face by the researchers 14 days before menstruation. After each student completes three menstrual cycles, the researchers will meet with the student and PMSS will be applied as a post-test. | Other | Experimental Group |
Primary outcome
premenstrual syndrome and emotional freedom technique
Time frame: 3 month Wıll Be Followed.
This outcome is assessed with the premenstrual syndrome scale. The lower the score on the scale, the lower the premenstrual syndrome.
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 25 Jun 2024.
- 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.
MERVE YAZAR study chair
merve.yazar@karatay.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFT in people with Premenstrual Syndrome, run by KTO Karatay 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 8 inclusion and 3 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 25 Jun 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?
premenstrual syndrome and emotional freedom technique (time frame: 3 month Wıll Be Followed.). 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 25 Jun 2024.