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临床试验/NCT06035380
NCT06035380招募中不适用

The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality

Eastern Mediterranean University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
2
主要终点
Aromatherapy Form

研究概览

简要总结

Evaluation of the effect of aromatherapy applied to women with vasomotor complaints on menopausal quality of life and vasomotor symptoms.

详细描述

Menopause, ovarian failure due to loss of follicular function of the ovaries accompanied by estrogen deficiency, causes permanent cessation of menstruation and loss of reproductive function. The period in which irregularities in the menstrual cycle begin to appear and the chance of fertility decreases is defined as the premenopausal period. During this period, vasomotor complaints occur. vasomotor complaints; It is reported as hot flashes, sweating and night sweats . It has been reported that women experience an average of 4-5 hot flashes per day , and this number reaches 20 in some women . These changes are usually the most severe and disturbing findings two or three years before menopause and can continue in later years . Studies have reported that vasomotor complaints negatively affect women's quality of life.

Application methods of aromatherapy with many therapeutic benefits, massage oil, face cream/oil, gel, body bath, hand and foot baths, compresses, hot towels, aromatic sprays, bath salt, inhalations (direct bottle, sniffing salt, drip on handkerchief), steam inhalation, facial mist, diffusion (diffuser, nebulizer, candle), ointment, mouthwash . Studies have also reported that aromatherapy methods used during menopause reduce vasomotor complaints and positively affect quality of life .

Evaluating and supporting women in line with the holistic nursing approach is among the responsibilities of nurses. Nurses' development of appropriate care standards in line with these goals constitutes an important step for women to step into a healthy and high-quality old age. Women's health nurses should provide care, counseling and training to increase the quality of life of women who spend one-third of their life in the menopausal period .

Studies have reported that aromatherapy has a positive effect on quality of life. However, studies on this subject in Türkiye and the Turkish Republic of Northern Cyprus are quite limited.

Purpose of the research; This study will be conducted to evaluate the effect of aromatherapy applied to women with vasomotor complaints on menopausal quality of life and vasomotor symptoms.

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
Single (Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Being able to speak Turkish,
  • Getting a score above 5 in VAS
  • Not to be allergic to the aromatherapy oils to be applied,
  • Lack of sense of smell,
  • Accepting to work with essential oils to be studied,
  • Not having entered menopause naturally,
  • Not using hormone replacement therapy,
  • Not using complementary alternative therapy,
  • Women who do not have a psychiatric problem,

排除标准

  • Wanting to leave the study.

结局指标

主要结局

Aromatherapy Form

时间窗: 12 week

The usage time and usage amount of the aromatherapy oil will be filled on the aroma therapy form for 12 weeks.

VISUAL ANALOGUE SCALE (VAS)

时间窗: Baseline, 1 day

VAS is used to convert some values that cannot be measured numerically. This scale is a safe, easily applicable test that has proven itself for a very long time and has been accepted in all the world literature. The test has no language and its ease of implementation is an important advantage. It was used in this study to determine how much hot flashes complaints experienced by women affect their lives. It was explained to the women that one end of the scale did not affect their life at all (0), and that it affected their life too much as they approached the other end (10). The women were asked to mark the number on a divided line with numbers from 0 to 10, and how much they thought their hot flashes had affected their lives.

Introductory Information Form

时间窗: Baseline, 1 day

women's socio-demographic characteristics , physical characteristics , pregnancy and birth information (pregnancy). number of people living together, spousal support, menstrual pattern, last menstrual period, age of mother's menopause, chronic diseases, smoking and alcohol use, vasomotor complaints, use of CAM and nursing support are included in a total of 27 questions.

Hot Flashes Scale Specific to Menopause

时间窗: Baseline, 1 day, the ninetieth day

The Menopause-Specific Hot Flashes Scale is used to measure the effect of hot flashes on overall quality of life (item 10) and nine specific activities (item 1-item 9). Nine specific activities: work, social activities, leisure activities, sleep, mood, concentration, relationships with others, sexuality, enjoyment of life. How much hot flashes affect the woman's life during the last two weeks is evaluated by numerical rating method from 0 to 10. A value of 0 means "not at all affected" and a value of 10 means "very much affected". The total score is calculated by adding the numerical values of each item.

Menopause-Specific Quality of Life Scale

时间窗: Baseline, 1 day, the ninetieth day

It is a 29-item Likert-type scale. The scale consists of four domains: vasomotor, psychosocial, physical and sexual. Vasomotor domain (questions 1-3), Psychosocial domain (questions 4-10), Physical space (questions 11-26), Sexual domain (questions 27-29), Each sub-domain score in the scale is ranked from 1 to 8. 1 point indicates that there is no problem with that. A score of 2 indicates that the problem exists, exists, but is not bothersome at all. Scores between 3 and 8 indicate the severity of the existing problem and its increasing degrees.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülsen Müsteyde Altan

lecturer

Eastern Mediterranean University

研究点 (2)

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