The Effect of Emotional Freedom Technique on Menopausal Symptoms, Quality of Life and Depression Level: An Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Determining the level of perimenopausal depression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Determining the level of perimenopausal depression
时间窗: 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.
Determining quality of life
时间窗: 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.
Assessment of menopausal symptoms
时间窗: 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).
Determining the level of anxiety
时间窗: One hour after the seventh measurement, all menopausal women in all three groups will be administered the SUE (eighth 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.
次要结局
未报告次要终点
研究者
Esra KARATAŞ OKYAY
Principal Investigator
Kahramanmaras Sutcu Imam University