Clinical trial NCT06338085: The Effect of Emotional Freedom Technique on Depressive and Menopausal Symptoms in Postmenopausal Women
Official title: The Effect of Emotional Freedom Technique on Depressive and Menopausal Symptoms in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 70
Sex: FEMALE
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the groups with a conventional therapy control group
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of EFT (Emotional Freedom Technique), a nonpharmacological method, on menopausal symptoms and depression in postmenopausal women. By determining the effectiveness of the Emotional Freedom Technique, the applicability of non-pharmacological method treatment in women with depression and menopausal symptoms in postmenopausal period will be proven. As a result of the study, if a positive effect on menopausal symptoms and depression is found in women with EFT, it can be recommended as an evidence-based alternative method in midwifery and nursing care.

Detailed description: Menopausal period is defined as the stage of transition to old age, which starts with the decline in ovarian function and decrease in reproductive capacity and ends with the end of reproductive ability over time. According to the WHO definition, natural menopause is the permanent cessation of menstruation with the loss of ovarian activity. The average age of menopause worldwide is 51 years and the transition to menopause occurs between the ages of 45 and 55. Menopause is defined after a 12-month amonereal period. Induced menopause is the cessation of menstruation as a result of surgical removal of both ovaries or external factors such as chemotherapy and radiotherapy. Before the age of 40, cessation of menstruation is defined as early menopause.

Approximately one-third of women experience no or mild symptoms during menopausal life, one-third experience moderate symptoms, and the remaining one-third may experience severe symptoms.The symptomatology experienced during this period is characterized by a hypoestrogenic state that occurs due to the decline in ovarian function in 60% to 80% of women. With menopause; estradiol level decreases 5-10 times, testosterone level decreases, follicle stimulating hormone (FSH) level increases 10-20 times and luteinizing hormone (LH) increases 3 times. As a result of insufficient secretion of sex hormones in women during this period, insomnia, vaginal dryness, irregular menstruation, depressive mood, irritability, headache, forgetfulness, dizziness, and vasomotor symptoms such as changes in body thermoregulation and night sweats may be observed. The experience of menopausal symptoms is individual and depends not only on hormonal changes but also on external factors such as living conditions, general health, social functioning and perceptions of aging. These factors can influence the perception and assessment of menopause.

The menopausal period is associated with various biopsychosocial changes, and some women may have physical and psychological symptoms of different severity. Increasing evidence suggests that increased sensitivity to estradiol fluctuation plays an important role in the development of depressive symptoms during the menopausal transition. A meta-analysis of 11 studies found that perimenopause is a period in which women are more likely to experience depressive symptoms compared to other menopause periods. In a descriptive study conducted to determine the quality of life in 99 perimenopausal women aged 45-55 years, almost all women experienced physical and psychosocial symptoms, while severe vasomotor symptoms and psychosocial symptoms were found in women who could not manage stress.

Depression affects approximately 350 million people worldwide and is a global burden. Depression is twice as common in women compared to men and the risk of depression may increase during periods of hormonal changes such as puberty, pregnancy and menopause. Although it is not specifically stated that there is a definite relationship between hormonal changes and depression, hormonal changes in the stages of women's life are called risky periods. Although the menopausal period, when hormonal changes are intense, is not associated with psychiatric disorders alone, it may increase the risk of a history of depressive disorder, especially in women in the perimenopausal period. Absolute levels and fluctuations of hypothalamic-pituitary-gonadal hormones during menopause are possible predictors of mood disorders and depression in perimenopause.

In a cross-sectional study conducted in Switzerland with 114 women aged 40-56 years, menopausal symptoms were significantly associated with perimenopausal depressive symptoms. As a result of a study on Women's Health Needs in China, in which 3199 women aged 40-55 years were examined, the prevalence of depressive symptoms was 19.3%, while there was a significant relationship between menopausal symptoms and depressive symptoms. In a descriptive study conducted with 176 women aged 45 to 60 years in Korea, it was determined that menopausal symptoms significantly affected depression status. In a descriptive study conducted with 749 women aged 45-60 years in Brazil, it was determined that moderate menopausal symptoms were significantly associated with depression or anxiety. Elaslan (2018) found that 64.4% of menopausal women aged 45-55 years experienced physical-psychological problems. Aygün (2019) conducted a study with 112 women aged 40-64 years and found that 25% of women had depression, while those who entered menopause had higher depression scores than those who did not.

and emotional liberation techniques in the treatment of depression. Emotional Freedom Technique (EFT) is a brief and evidence-based intervention that combines elements of acupressure point exposure, cognitive therapy and somatic stimulation on the face and body. Participants' distress about any issue or situation is determined. They are asked to rate their level of distress on a Likert-type scale out of 10 (10 representing maximum distress and 0 representing minimum distress). This is called the Subjective Distress Unit (SUDS) scale. Participants then indicate their concerns in a 'Set-up Statement' which helps to translate them into their own level of distress. This is usually expressed as: "Although I have this problem (e.g. anger), I accept myself deeply and completely." The first half of the Set-up Statement emphasizes the exposure, while the second half frames the traumatizing event in the context of self-acceptance. The participant then engages in somatic tapping on acupuncture points on the body while repeating an abbreviated phrase to stay engaged (e.g., feeling angry). This is called the "Reminder Phrase". The tapping sequence uses 8 acupoints on the face and upper body and is normally repeated until the SUDS rating is very low (1 or 0). In order for the EFT treatment outcome to be successful, the method is usually performed between four and 10 sessions. Comorbid conditions such as anxiety and depression improve simultaneously. Contributes to the regulation of biological markers such as stress hormones. The risk of adverse events is low. The application provides psychological as well as physiological improvements. The method can be used in online and telemedicine applications.

Emotional Freedom Technique (EFT) is defined as a clinical procedure that nurses can offer to patients to relieve psychological and physical distress. EFT is a therapy that combines cognitive and somatic elements. It can effectively treat physiological and psychological symptoms. This therapy helps the person to calm down after lightly tapping on certain points. As a result of the systematic review study conducted to determine the effect of EFT, the Emotional Freedom Technique for Pain, Anxiety Disorders and Depression, it was determined that it is a therapy that can affect physiological symptoms, pain, anxiety disorders and depression. It is recommended to apply EFT as a method of clearing the mind, focusing (such as meditation) and improving attitudes to better cope with emotional problems. In a study conducted to determine the effect of EFT on menopausal symptoms in women with breast cancer receiving hormonal treatment, women (n=41) were given EFT training for 3 hours a week for 3 weeks. Then, they practiced EFT on themselves for 9 weeks. At the end of the study, a significant decrease in the degree and number of hot flashes among menopausal symptoms and a significant decrease in anxiety and depression scores were found. In a study conducted to determine the effect of EFT on depression in patients diagnosed with depression, 100 participants were divided into two separate groups. The intervention group received 40 minutes of EFT for three consecutive days in addition to routine treatment. The other group received only conventional treatment. As a result of the study, the depression scale score of the intervention group decreased more than before the treatment. The effect of EFT on depression According to the results of the meta-analysis study in which 20 studies were included, it was determined that EFT treatment given individually or as a group for depression was superior to psychopharmacology and psychotherapy. As a result of the meta-analysis study conducted to examine the effectiveness of EFT application used in the treatment of post-traumatic stress disorder (PTSD), it was determined that the effect size of EFT application on PTSD, anxiety and depression was significant. In the RCT examining the effect of EFT on postmenopausal depression in menopausal women, 88 women with mild and moderate depression were divided into two groups. Those in the intervention group received 2 sessions of EFT training. Then, they were asked to continue EFT practice once a day for 8 weeks. The control group received training on sham acupressure points. As a result of the study, it was determined that 8-week EFT practice significantly reduced depression scores in postmenopausal women.

The menopausal period is one of the most challenging and important phases of a woman's life. This period can be a troublesome time when women may experience physical and psychological changes and some problems. Women's physical and psychosocial health can be negatively affected. This negative situation can affect not only the woman but also the family and society. According to Tuik 2019 data, life expectancy in women was determined as 81.3 years. Considering the life expectancy in women, women spend a significant part of their lives in the menopausal period. Therefore, it is important to treat menopausal and depressive symptoms experienced during this period. In the menopausal period, not only medical treatment is not sufficient, but effective and qualified counseling and non-pharmacological methods are used.

Eligibility criteria: Inclusion Criteria:

* Being in menopausal period (no menstruation in the last 12 months)
* Literacy,
* No visual, auditory and mental disabilities

Exclusion Criteria:

* Receiving cancer treatment during research,
* Diagnosed with depression during the research,
* Taking any psychiatric medication during the study,
* Receiving hormone replacement therapy before or during the trial
* Who did not attend the Eft sessions

Primary outcomes:
measure: Beck Depression Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Menopause Rating Scale (MRS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: family health center no. 1 in Çayyolu
state: Çankaya
Study officials:
affiliation: Gülhane Institute of Health Sciences
name: Meltem UĞURLU
role: STUDY_DIRECTOR
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