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AzTrials

MenopauseNCT06158672

The Effect of Emotional Freedom Technique on Menopausal Symptoms, Quality of Life and Depression Level

A study testing Emotional freedom technique group in people with Menopause, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Emotional freedom technique will be applied to menopausal women. Emotional freedom technique group, sham emotional freedom technique group and control groups each consisted of 35 menopausal women. Read more about this study

Who is it for?
Ages 45 to 59 years, women onlyHealthy volunteers can take part
Conditions the study is for
Menopause
What is being tested?
Emotional freedom technique group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
2 sitesTurkey (Türkiye)
Study dates
5 Dec 2023to 30 Jun 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 45 to 59 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • A person who has gone through menopause naturally,
  • No menstruation for the last one year,
  • Literate,
  • Not taking Hormone Replacement Therapy,
  • No oncologic disease,
  • No infection, wound, scar in the tapping areas,
  • Women who are able to communicate will be included in the study.

Who cannot join

  • One who has not gone through menopause naturally,
  • Illiterate,
  • Receiving Hormone Replacement Therapy,
  • Women with conditions such as infections, wounds, scars in the tapping areas.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Firat Family Health Center

    Malatya

  • Göztepe Family Health Center

    Malatya

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Emotional Freedom Technique on Menopausal Symptoms, Quality of Life and Depression Level: An Experimental Study

Emotional freedom technique will be applied to menopausal women. Emotional freedom technique group, sham emotional freedom technique group and control groups each consisted of 35 menopausal women.

Read the detailed description

Objective: The aim of the study was to determine the effect of emotional freedom technique (EFT) on menopausal symptoms, quality of life and depression level.

Materials and Methods: This randomized controlled trial will be conducted with a total of 105 menopausal women at Fırat Family Health Center and Göztepe Family Health Center between January 2024 and June 2024 (35 EFT, 35 sham, 35 control). EFT and Sham EFT will be applied in the study. Women in the EFT group will receive EFT four times at one week intervals. Women in the Sham EFT group will receive Sham EFT four times with one week intervals. Before the applications, pre-test data will be obtained by filling out the Personal Information Form, Perimenopausal Depression Scale, Menopause Specific Quality of Life Scale and Menopause Symptom Assessment Scale before the application of Emotional Freedom Technique. After the applications, post-test data will be obtained by filling out the Perimenopausal Depression Scale, Menopause Specific Quality of Life Scale and Menopause Symptom Assessment Scale. In addition, the Subjective Units of Experience (SUE) scale will be applied before and after each EFT intervention.

Conditions
Menopause
Being tested
Emotional freedom technique group, Sham emotional freedom technique group
Keywords
Menopause Symptoms, Quality of Life, Depression, Emotional Freedom Technique
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional freedom technique groupBehavioural

    Menopausal women in the emotional freedom technique group will be administered the emotional freedom technique by the researcher a total of 4 times at one week intervals.

  • Sham emotional freedom technique groupBehavioural

    Menopausal women in the sham emotional freedom technique group will be administered sham emotional freedom technique by the researcher a total of 4 times with one week intervals.

Study groups in NCT06158672
Study groupRoleWhat they receive
Emotional freedom technique groupExperimentalEmotional freedom technique will be applied to menopausal women in the emotional freedom technique group.
Receives: Behavioral: Emotional freedom technique group
Sham Emotional freedom technique groupPlacebo comparatorMenopausal women in the sham emotional freedom technique group will receive sham emotional freedom technique.
Receives: Behavioral: Sham emotional freedom technique group
Control groupNo interventionMenopausal women in the control group will not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determining the level of perimenopausal depression

    The scale was developed to rate the severity of perimenopausal depression symptoms. The scale consists of 12 items and five subscales related to energy, paranoid ideation, irritability, self-esteem, isolation, anxiety, somatic symptoms, sleep disturbance, weight, sexual interest, memory and concentration. All items of the scale are scored between 0 and 4. The lowest score that can be obtained from the scale is 0 and the highest score is 48. An increase in the scale score indicates an increase in depressive symptom status. A score range of 20-24 points indicates mild perimenopausal depression, a score range of 24- 32 points indicates moderate perimenopausal depression requiring treatment, and a score of 32 points and above indicates severe perimenopausal depression requiring treatment.

    Measured: The Perimenopausal Depression Scale will be administered to three groups of menopausal women on day one (first interview).

  2. Determining the level of perimenopausal depression

    The scale was developed to rate the severity of perimenopausal depression symptoms. The scale consists of 12 items and five subscales related to energy, paranoid ideation, irritability, self-esteem, isolation, anxiety, somatic symptoms, sleep disturbance, weight, sexual interest, memory and concentration. All items of the scale are scored between 0 and 4. The lowest score that can be obtained from the scale is 0 and the highest score is 48. An increase in the scale score indicates an increase in depressive symptom status. A score range of 20-24 points indicates mild perimenopausal depression, a score range of 24- 32 points indicates moderate perimenopausal depression requiring treatment, and a score of 32 points and above indicates severe perimenopausal depression requiring treatment.

    Measured: The Perimenopausal Depression Scale will be administered to three groups of menopausal women at the last interview (after the 4th intervention at one week interval).

  3. Determining quality of life

    The Menopause Specific Quality of Life Scale assesses the quality of life of menopausal women. The scale consists of 29 Likert-type questions and 4 sub-domains: vasomotor, psychosocial, physical and sexual. The score for each question varies between 1 and 8. In scoring, a score of 1 indicates that the situation was not experienced, a score of 2 indicates that the situation was experienced but not disturbing, and a score between 3-8 indicates the severity of the situation. The score of each sub-domain is obtained by averaging the scores of the items in the sub-domain. A high score on the scale indicates a low quality of life.

    Measured: The Menopause Specific Quality of Life Scale will be administered to three groups of menopausal women on day one (first interview).

  4. Determining quality of life

    The Menopause Specific Quality of Life Scale assesses the quality of life of menopausal women. The scale consists of 29 Likert-type questions and 4 sub-domains: vasomotor, psychosocial, physical and sexual. The score for each question varies between 1 and 8. In scoring, a score of 1 indicates that the situation was not experienced, a score of 2 indicates that the situation was experienced but not disturbing, and a score between 3-8 indicates the severity of the situation. The score of each sub-domain is obtained by averaging the scores of the items in the sub-domain. A high score on the scale indicates a low quality of life.

    Measured: The Menopause Specific Quality of Life Scale will be administered to three groups of menopausal women at the last interview (after the 4th intervention at one week interval).

  5. Assessment of menopausal symptoms

    The Menopausal Symptoms Rating Scale measures the severity of menopausal symptoms. In the Likert-type scale consisting of a total of 11 items including menopausal complaints, there are "0= None", "1= Mild", "2= Moderate", "3= Severe" and "4= Very severe" options for each item. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0 and the highest score is 44. An increase in the total score indicates an increase in the severity of the complaints experienced. The scale consists of three subscales (Somatic Complaints Subscale, Psychological Complaints Subscale, Urogenital Complaints Subscale).

    Measured: The Menopausal Symptoms Rating Scale will be administered to three groups of menopausal women on day one (first interview).

  6. Assessment of menopausal symptoms

    The Menopausal Symptoms Rating Scale measures the severity of menopausal symptoms. In the Likert-type scale consisting of a total of 11 items including menopausal complaints, there are "0= None", "1= Mild", "2= Moderate", "3= Severe" and "4= Very severe" options for each item. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0 and the highest score is 44. An increase in the total score indicates an increase in the severity of the complaints experienced. The scale consists of three subscales (Somatic Complaints Subscale, Psychological Complaints Subscale, Urogenital Complaints Subscale).

    Measured: The Menopause Symptoms Assessment Scale will be administered to three groups of menopausal women at the last interview (after the 4th intervention at one week interval).

  7. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of menopausal women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: The Subjective Units of Experience (SUE) scale will be administered to three groups of menopausal women on day one (first interview).

  8. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of menopausal women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: One hour after the first interview, all menopausal women in all three groups will be administered the SUE (second measure).

  9. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of menopausal women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: Seven days after the first interview, all menopausal women in all three groups will be administered the SUE (third measurement).

  10. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of menopausal women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: One hour after the third measurement, all menopausal women in all three groups will be administered the SUE (fourth measurement).

  11. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of menopausal women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: Seven days after the fourth measurement, all menopausal women in all three groups will be administered the SUE (fifth measurement).

  12. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of menopausal women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: One hour after the fifth measurement, all menopausal women in all three groups will be administered the SUE (sixth measurement).

  13. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of menopausal women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: Seven days after the sixth measurement, all menopausal women in all three groups will undergo the SUE (seventh measurement).

  14. Determining the level of anxiety

    Subjective Units of Experience (SUE) will be applied to determine the anxiety level of menopausal women. The SUE is used to determine the intensity of one's emotions at the beginning and end of the therapy. The scale is scored between -10 and +10, with negative numbers indicating negative/unpleasant experiences and positive numbers indicating positive/pleasant experiences.

    Measured: One hour after the seventh measurement, all menopausal women in all three groups will be administered the SUE (eighth measurement).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2023
  2. Study start5 Dec 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

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
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06158672
Sponsor's protocol ID
KSUESRAKARATASOKYAY003
Status last verified
Apr 2025
First submitted
18 Nov 2023
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: we don't share individual participant data with other researchers

Publications

  • Mehdipour A, Abedi P, Ansari S, Dastoorpoor M. The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial. J Complement Integr Med. 2021 May 19;19(3):737-742. doi: 10.1515/jcim-2020-0245. eCollection 2022 Sep 1.

    PubMed 34013673

Questions about this trial

What is this clinical trial studying?

A study testing Emotional freedom technique group in people with Menopause, run by Kahramanmaras Sutcu Imam University at 2 sites 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 7 inclusion and 4 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Determining the level of perimenopausal depression (time frame: The Perimenopausal Depression Scale will be administered to three groups of menopausal women on day one (first interview).). The study lists 14 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 NCT06158672, which also lists 1 linked publication.

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 30 Apr 2025.

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