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

NCT06158672 | Completed

• 1 other identifier: KSUESRAKARATASOKYAY003
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Menopause

Keywords

Menopause Symptoms; Quality of Life; Depression; Emotional Freedom Technique

Outcome Measures

Primary Outcomes (14)

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (3)

Emotional freedom technique group

EXPERIMENTAL

Emotional freedom technique will be applied to menopausal women in the emotional freedom technique group.

Behavioral: Emotional freedom technique group

Sham Emotional freedom technique group

PLACEBO COMPARATOR

Menopausal women in the sham emotional freedom technique group will receive sham emotional freedom technique.

Behavioral: Sham emotional freedom technique group

Control group

NO INTERVENTION

Menopausal women in the control group will not receive any intervention.

Interventions

Emotional freedom technique group BEHAVIORAL

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.

Emotional freedom technique group

Sham emotional freedom technique group BEHAVIORAL

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.

Sham Emotional freedom technique group

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (2)

Firat Family Health Center

Malatya, Turkey (Türkiye)

Location

Göztepe Family Health Center

Malatya, Turkey (Türkiye)

Location

Related 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.

  PMID: 34013673 BACKGROUND

Related Links

• Description citation link

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Esra KARATAŞ OKYAY, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

• Zeliha ÖZŞAHİN, PhD

  Inonu University

  STUDY DIRECTOR

• Çiğdem KARAKAYALI AY, PhD

  Kahramanmaras Sutcu Imam University

  STUDY DIRECTOR

• Sinem GÜVEN SANTUR, Master

  Inonu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 6, 2023
• Study Start: December 5, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)