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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06158672
• Other study ID #: KSUESRAKARATASOKYAY003
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Kahramanmaras Sutcu Imam University
• Contact: Esra KARATAS OKYAY, PhD
• Phone: 05432125225
• Email: esrakaratas44[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 (53 EFT, 53 music, 53 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Menopause

Intervention

Behavioral:
• Emotional freedom technique group
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 group
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.

Locations

Country	Name	City	State
Turkey	Firat Family Health Center	Malatya
Turkey	Göztepe Family Health Center	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The Perimenopausal Depression Scale will be administered to three groups of menopausal women on day one (first interview).
Primary	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.	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).
Primary	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.	The Menopause Specific Quality of Life Scale will be administered to three groups of menopausal women on day one (first interview).
Primary	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.	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).
Primary	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).	The Menopausal Symptoms Rating Scale will be administered to three groups of menopausal women on day one (first interview).
Primary	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).	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).
Primary	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.	The Subjective Units of Experience (SUE) scale will be administered to three groups of menopausal women on day one (first interview).
Primary	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.	One hour after the first interview, all menopausal women in all three groups will be administered the SUE (second measure).
Primary	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.	Seven days after the first interview, all menopausal women in all three groups will be administered the SUE (third measurement).
Primary	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.	One hour after the third measurement, all menopausal women in all three groups will be administered the SUE (fourth measurement).
Primary	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.	Seven days after the fourth measurement, all menopausal women in all three groups will be administered the SUE (fifth measurement).
Primary	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.	One hour after the fifth measurement, all menopausal women in all three groups will be administered the SUE (sixth measurement).
Primary	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.	Seven days after the sixth measurement, all menopausal women in all three groups will undergo the SUE (seventh measurement).
Primary	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.	One hour after the seventh measurement, all menopausal women in all three groups will be administered the SUE (eighth measurement).

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