The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality of Life and Vasomotor Symptoms
Aromatherapy
1 other identifier
interventional
66
1 country
1
Brief Summary
Evaluation of the effect of aromatherapy applied to women with vasomotor complaints on menopausal quality of life and vasomotor symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2023
CompletedFirst Submitted
Initial submission to the registry
June 8, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedSeptember 13, 2023
September 1, 2023
6 months
June 8, 2023
September 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
VISUAL ANALOGUE SCALE (VAS)
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.
Baseline, 1 day
Introductory Information Form
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.
Baseline, 1 day
Hot Flashes Scale Specific to Menopause
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.
Baseline, 1 day, the ninetieth day
Menopause-Specific Quality of Life Scale
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.
Baseline, 1 day, the ninetieth day
Aromatherapy Form
The usage time and usage amount of the aromatherapy oil will be filled on the aroma therapy form for 12 weeks.
12 week
Study Arms (3)
rose oil
EXPERIMENTALrose oil will be used
mint oil
EXPERIMENTALmint oil will be used
plasebo
PLACEBO COMPARATORdrinking water will be used
Interventions
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- Wanting to leave the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastern Mediterranean University
Famagusta, 99628, Cyprus
Related Publications (3)
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.
PMID: 28748167BACKGROUNDJohnson 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.
PMID: 30868921BACKGROUNDShort M. Menopause, mood and management. Climacteric. 2003 Aug;6 Suppl 2:33-6.
PMID: 14669842BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
June 8, 2023
First Posted
September 13, 2023
Study Start
March 30, 2023
Primary Completion
October 1, 2023
Study Completion
December 31, 2023
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share