Clinical trial NCT06158672: The Effect of Emotional Freedom Technique on Menopausal Symptoms, Quality of Life and Depression Level
Official title: The Effect of Emotional Freedom Technique on Menopausal Symptoms, Quality of Life and Depression Level: An Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Menopause Symptoms
Quality of Life
Depression
Emotional Freedom Technique
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 105
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determining the level of perimenopausal depression
timeFrame: The Perimenopausal Depression Scale will be administered to three groups of menopausal women on day one (first interview).
measure: Determining the level of perimenopausal depression
timeFrame: 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).
measure: Determining quality of life
timeFrame: The Menopause Specific Quality of Life Scale will be administered to three groups of menopausal women on day one (first interview).
measure: Determining quality of life
timeFrame: 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).
measure: Assessment of menopausal symptoms
timeFrame: The Menopausal Symptoms Rating Scale will be administered to three groups of menopausal women on day one (first interview).
measure: Assessment of menopausal symptoms
timeFrame: 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).
measure: Determining the level of anxiety
timeFrame: The Subjective Units of Experience (SUE) scale will be administered to three groups of menopausal women on day one (first interview).
measure: Determining the level of anxiety
timeFrame: One hour after the first interview, all menopausal women in all three groups will be administered the SUE (second measure).
measure: Determining the level of anxiety
timeFrame: Seven days after the first interview, all menopausal women in all three groups will be administered the SUE (third measurement).
measure: Determining the level of anxiety
timeFrame: One hour after the third measurement, all menopausal women in all three groups will be administered the SUE (fourth measurement).
measure: Determining the level of anxiety
timeFrame: Seven days after the fourth measurement, all menopausal women in all three groups will be administered the SUE (fifth measurement).
measure: Determining the level of anxiety
timeFrame: One hour after the fifth measurement, all menopausal women in all three groups will be administered the SUE (sixth measurement).
measure: Determining the level of anxiety
timeFrame: Seven days after the sixth measurement, all menopausal women in all three groups will undergo the SUE (seventh measurement).
measure: Determining the level of anxiety
timeFrame: One hour after the seventh measurement, all menopausal women in all three groups will be administered the SUE (eighth measurement).
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Firat Family Health Center
city: Malatya
country: Turkey
facility: Göztepe Family Health Center
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Esra KARATAŞ OKYAY, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inonu University
name: Zeliha ÖZŞAHİN, PhD
role: STUDY_DIRECTOR
affiliation: Kahramanmaras Sutcu Imam University
name: Çiğdem KARAKAYALI AY, PhD
role: STUDY_DIRECTOR
affiliation: Inonu University
name: Sinem GÜVEN SANTUR, Master
role: STUDY_DIRECTOR
References:
citation: 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.