- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06158672
The Effect of Emotional Freedom Technique on Menopausal Symptoms, Quality of Life and Depression Level
The Effect of Emotional Freedom Technique on Menopausal Symptoms, Quality of Life and Depression Level: An Experimental Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Malatya, Turkey
- Firat Family Health Center
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Malatya, Turkey
- Göztepe Family Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Emotional freedom technique group
Emotional freedom technique will be applied to menopausal women in the emotional freedom technique group.
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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.
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Placebo Comparator: Sham Emotional freedom technique group
Menopausal women in the sham emotional freedom technique group will receive sham emotional freedom technique.
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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.
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No Intervention: Control group
Menopausal women in the control group will not receive any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 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.
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The Perimenopausal Depression Scale will be administered to three groups of menopausal women on day one (first interview).
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Determining the level of perimenopausal depression
Time Frame: 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).
|
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.
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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).
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Determining quality of life
Time Frame: The Menopause Specific Quality of Life Scale will be administered to three groups of menopausal women on day one (first interview).
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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.
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The Menopause Specific Quality of Life Scale will be administered to three groups of menopausal women on day one (first interview).
|
|
Determining quality of life
Time Frame: 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).
|
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.
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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).
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Assessment of menopausal symptoms
Time Frame: The Menopausal Symptoms Rating Scale will be administered to three groups of menopausal women on day one (first interview).
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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).
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The Menopausal Symptoms Rating Scale will be administered to three groups of menopausal women on day one (first interview).
|
|
Assessment of menopausal symptoms
Time Frame: 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).
|
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).
|
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).
|
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Determining the level of anxiety
Time Frame: The Subjective Units of Experience (SUE) scale will be administered to three groups of menopausal women on day one (first interview).
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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.
|
The Subjective Units of Experience (SUE) scale will be administered to three groups of menopausal women on day one (first interview).
|
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Determining the level of anxiety
Time Frame: One hour after the first interview, all menopausal women in all three groups will be administered the SUE (second measure).
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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.
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One hour after the first interview, all menopausal women in all three groups will be administered the SUE (second measure).
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Determining the level of anxiety
Time Frame: Seven days after the first interview, all menopausal women in all three groups will be administered the SUE (third measurement).
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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.
|
Seven days after the first interview, all menopausal women in all three groups will be administered the SUE (third measurement).
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Determining the level of anxiety
Time Frame: One hour after the third measurement, all menopausal women in all three groups will be administered the SUE (fourth measurement).
|
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.
|
One hour after the third measurement, all menopausal women in all three groups will be administered the SUE (fourth measurement).
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Determining the level of anxiety
Time Frame: Seven days after the fourth measurement, all menopausal women in all three groups will be administered the SUE (fifth measurement).
|
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.
|
Seven days after the fourth measurement, all menopausal women in all three groups will be administered the SUE (fifth measurement).
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Determining the level of anxiety
Time Frame: One hour after the fifth measurement, all menopausal women in all three groups will be administered the SUE (sixth measurement).
|
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.
|
One hour after the fifth measurement, all menopausal women in all three groups will be administered the SUE (sixth measurement).
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Determining the level of anxiety
Time Frame: Seven days after the sixth measurement, all menopausal women in all three groups will undergo the SUE (seventh measurement).
|
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.
|
Seven days after the sixth measurement, all menopausal women in all three groups will undergo the SUE (seventh measurement).
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Determining the level of anxiety
Time Frame: One hour after the seventh measurement, all menopausal women in all three groups will be administered the SUE (eighth measurement).
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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.
|
One hour after the seventh measurement, all menopausal women in all three groups will be administered the SUE (eighth measurement).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Esra KARATAŞ OKYAY, PhD, Kahramanmaraş Sütçü İmam University
- Study Director: Zeliha ÖZŞAHİN, PhD, Inonu University
- Study Director: Çiğdem KARAKAYALI AY, PhD, Kahramanmaraş Sütçü İmam University
- Study Director: Sinem GÜVEN SANTUR, Master, Inonu University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSUESRAKARATASOKYAY003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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