AromatherapyAromatherapyNCT06035380
The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality of Life and Vasomotor Symptoms
A study testing mint oil group and rose oil group in people with Aromatherapy, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Evaluation of the effect of aromatherapy applied to women with vasomotor complaints on menopausal quality of life and vasomotor symptoms. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aromatherapy
- What is being tested?
- mint oil group and rose oil group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteCyprus
- Study dates
- 30 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- Not using hormone replacement therapy,
- Not using complementary alternative therapy,
- Women who do not have a psychiatric problem,
Who cannot join
- -Wanting to leave the study.
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Eastern Mediterranean University
Famagusta, 99628
About this study
Official title: The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality
Evaluation of the effect of aromatherapy applied to women with vasomotor complaints on menopausal quality of life and vasomotor symptoms.
Read the 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.
- Conditions
- Aromatherapy
- Being tested
- placebo group, mint oil group, rose oil group
- Keywords
- Aromatherapy, Vasomotor Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo groupOther
aromatherapy
mint oil groupOther
aromatherapy
rose oil groupOther
aromatherapy
| Study group | Role | What they receive |
|---|---|---|
| rose oil | Experimental | rose oil will be used Receives: Other: rose oil group |
| mint oil | Experimental | mint oil will be used Receives: Other: mint oil group |
| plasebo | Placebo comparator | drinking water will be used Receives: Other: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start30 Mar 2023
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AromatherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülsen Müsteyde Altan, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035380
- Sponsor's protocol ID
- EasternMU-SBF-HB-GMAD-01
- Acronym
- Aromatherapy
- Status last verified
- Sep 2023
- First submitted
- 8 Jun 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28748167Johnson 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.
PubMed 30868921Short M. Menopause, mood and management. Climacteric. 2003 Aug;6 Suppl 2:33-6.
PubMed 14669842
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy to Women With Vasomotor Complaints on Menopausal Quality
- ClinicalTrials.gov ID
- NCT06035380
- Acronym / sponsor ID
- Aromatherapy / EasternMU-SBF-HB-GMAD-01
- Conditions
- Aromatherapy
- Keywords
- Aromatherapy, Vasomotor Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| rose oil | Experimental | Other: rose oil grouprose oil will be used |
| mint oil | Experimental | Other: mint oil groupmint oil will be used |
| plasebo | Placebo comparator | Other: placebo groupdrinking water will be used |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (1 listed)
- -Wanting to leave the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo grouparomatherapy | Other | plasebo |
| mint oil grouparomatherapy | Other | mint oil |
| rose oil grouparomatherapy | Other | rose oil |
Primary outcome
VISUAL ANALOGUE SCALE (VAS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Aromatherapy Form
Time frame: 12 week
The usage time and usage amount of the aromatherapy oil will be filled on the aroma therapy form for 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 28748167Mohebitabar 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.
- Background: PubMed 30868921Johnson 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.
- Background: PubMed 14669842Short M. Menopause, mood and management. Climacteric. 2003 Aug;6 Suppl 2:33-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mint oil group and rose oil group in people with Aromatherapy, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülsen Altan, specialist nurse (05338597132 ext. 3666303004, gulsen.altan@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VISUAL ANALOGUE SCALE (VAS) (time frame: Baseline, 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035380, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.