Clinical trial NCT06035380: The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality of Life and Vasomotor Symptoms
Official title: The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aromatherapy
Keywords: Aromatherapy, Vasomotor Symptoms
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 66
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

The population of the study will consist of women living in the Turkish Republic of Northern Cyprus, Famagusta District and reporting more than 5 vasomotor complaints according to the Visual Analog Scale. The sample size was determined as 66 by G\*Power analysis. Three groups will be formed by randomization method from the people who agreed to participate in the study, while rose oil will be used in the first group, peppermint oil will be used in the second group, and the third group will form the placebo group.

Essential oils to be used in groups to be treated with aromatherapy are rose and mint oils. In addition to the cooling effect of rose oil, it is known that thanks to its pleasant smell, it helps the user to feel good and is also effective in reducing menopausal symptoms. At the same time, peppermint oil is stated to revitalize the body, increase energy level, provide refreshment and reduce menopausal symptoms . It will be used after diluting by adding 10 ml of black cumin oil as carrier oil to 2 drops of rose and mint oils to be used in the study.

In 2021, the researcher completed the 90-hour theoretical and 16-hour applied aromatherapy training program, coordinated by Riccon Academy-Bern-Schweiz and Adamer training center, and received her certificate.

The placebo group will be asked to use the spray whenever they complain of hot flashes, using drinking water.

With this randomized controlled study, it is aimed to evaluate the effect of aromatherapy applied to women with vasomotor complaints on menopausal quality of life and vasomotor symptoms, and to provide evidence for the care to be offered to menopausal women.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

-Wanting to leave the study.

Primary outcomes:
measure: VISUAL ANALOGUE SCALE (VAS)
timeFrame: Baseline, 1 day
measure: Introductory Information Form
timeFrame: Baseline, 1 day
measure: Hot Flashes Scale Specific to Menopause
timeFrame: Baseline, 1 day, the ninetieth day
measure: Menopause-Specific Quality of Life Scale
timeFrame: Baseline, 1 day, the ninetieth day
measure: Aromatherapy Form
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
References:
citation: Mohebitabar S, Shirazi M, Bioos S, Rahimi R, Malekshahi F, Nejatbakhsh F. Therapeutic efficacy of rose oil: A comprehensive review of clinical evidence. Avicenna J Phytomed. 2017 May-Jun;7(3):206-213.
citation: Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.
citation: Short M. Menopause, mood and management. Climacteric. 2003 Aug;6 Suppl 2:33-6.