Premenstrual Syndrome-PMSAromatherapyNCT06289764
The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on PMS
A study testing Bergamot Essential Oil, Grapefruit Essential Oil and Sweet almond oil in people with Premenstrual Syndrome-PMS, run by Esra ÖZER at 1 site in Turkey (Türkiye).
Trial summary
Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome-PMS
- What is being tested?
- Bergamot Essential Oil, Grapefruit Essential Oil and Sweet almond oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 24 Jun 2024
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be between the ages of 18-35
- Experiencing at least 5 of the pms complaints (self-report)
- Not having respiratory diseases such as asthma and bronchitis (self-report)
- No pregnancy or suspected pregnancy (self-report)
- Not being allergic to any substance (self-report)
- Not having a systemic disease such as diabetes, hypertension (self-report)
Who cannot join
- Under 18, over 35 years of age Not experiencing pms complaints Finding anosmia Presence of respiratory system diseases Allergic symptoms to aromatherapy Being pregnantHaving a chronic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Medipol Unıversty
Ankara, Altındağ, 06000
About this study
Official title: The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on Premenstrual Syndrome and Menstrual Symptoms
Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being.
Premenstrual syndrome (PMS) is a health problem characterized by the periodic occurrence of physical, cognitive, emotional and behavioral symptoms during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is reported that approximately 80-95% of women complain of PMS complaints.
Although the use of aromatherapy in womens health is widespread, there is no study comparing bergamot and grapefruit essential oils. The aim of this study was to determine the effect of aromatherapy with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms.
Read the detailed description
Aromatherapy is the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being.The fact that aromatherapy is a noninvasive procedure and is easy to use allows aromatherapy to be widely used . Aromatic oils can be applied in four basic ways. These are topical (touch, compress or bath), internal (mouthwash, vaginal or anal suppositories), oral (capsules or dilution in honey, alcohol or diluent) and inhalation (direct or indirect inhalation with or without steam). Essential oils, which can be applied in various ways, can directly reach the neocortex part of the brain through connections from the limbic system to the hypothalamus via odor. As a result of the effect of aromatic oils on the central nervous system, relaxation, sedation or stimulating effects occur, and thanks to the information flow reaching the brain with the stimulation of the central nervous system, the energy blockage in the body is broken and energy is released as a result. The healing process is supported by the balanced spread of the energy flow to the relevant organs, and physical and mental well-being emerges. Aromatherapy is used in many health fields as well as in womens health.
Premenstrual syndrome (PMS) is a health problem characterized by periodic physical, cognitive, emotional and behavioral symptoms that occur periodically during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is stated that approximately 80-95% of women complain of PMS complaints. In studies in the literature, aromatherapy with various essential oils (rose, geranium, sage, lavender) was applied to women complaining of PMS complaints and it was determined that aromatherapy application had both psychological and physical positive effects by stating that depression, anxiety, anxiety, irritability, and pain perception decreased.
Menstrual symptoms are recognized as one of the biggest problems that negatively affect the health status and quality of life among women of reproductive age worldwide. Menstrual symptoms such as dysmenorrhea, heavy menstrual bleeding and mood disorders during the premenstrual period are known to be common in the general population. Menstrual symptoms affect womens activities of daily living and quality of life. In studies in the literature, aromatherapy with various essential oils (rose, sage, ginger) was applied to women with dysmenorrhea, but no study was found in which all menstrual symptoms were measured.
Bergamot (Citrus aurantium bergamia), a small tree belonging to the Rutaceae family among citrus fruits, grows in the Mediterranean region and is especially native to the southern coast of Italy. Bergamot essential oil (BEO) is an essential oil produced by extracting the fruit from the rind by cold pressing procedure or steam distillation. Bergamot essential oil has analgesic, sleep quality enhancing, relaxation, anti-inflammatory and antidepressant effects.
Grapefruit, one of the citrus families with the largest production in the world, is famous for its taste and nutritional value, and grapefruit essential oil has antibacterial, antimicrobial, antiseptic, antidepressant, anti-edema and appetite regulating effects.
Although the use of aromatherapy in womens health is widespread, no study comparing bergamot and grapefruit essential oil has been found. The aim of this study is to determine the effect of aromatherapy application with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms.
- Conditions
- Premenstrual Syndrome-PMS
- Being tested
- Bergamot Essential Oil, Grapefruit Essential Oil, Sweet almond oil
- Keywords
- Aromatherapy, Premenstrual syndrome, Menstrual symptom
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bergamot Essential OilOther
Selected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles.
Grapefruit Essential OilOther
Selected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles.
Sweet almond oilOther
Selected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Sweet almond oil | Placebo comparator | Premenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm. Receives: Other: Sweet almond oil |
| Bergamot essential oil | Experimental | Premenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm Receives: Other: Bergamot Essential Oil |
| Grapefruit essential oil | Experimental | Premenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm Receives: Other: Grapefruit Essential Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual syndrome scale (PMS)
It is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms. A minimum of 44 and a maximum of 220 points can be obtained from the scale. An increase in the score obtained from the scale indicates that the intensity of PMS symptoms increases. In the PMS scale, PMS is considered to be "present" if it exceeds 50% (110) of the total scale score (220).
Measured: Baseline and three months later
Secondary outcomes (1)
Menstrual Symptom Scale
Scale items are numbered according to the allocated factors for ease of use. 1-13. Items belong to the "Negative effects/somatic complaints" subscale, items 14-19. The items refer to the "Menstrual pain symptoms" subscale and items 20-22. The items belong to the "Coping methods" sub-dimension. Cronbach's Alpha value is 0.86. It is a five-point Likert type scale consisting of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions. Average score for sub-dimensions Its increase indicates that the severity of menstrual symptoms related to that sub-dimension increases.
Measured: Baseline and three months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Feb 2024
- Primary completion20 Apr 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual Syndrome-PMSStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esra ÖZER
- Sponsor type
- University, hospital or other
- Collaborators
- KTO Karatay University
- Responsible party
- Sponsor-investigator, Esra ÖZER, Ankara Medipol University
- Investigators
- Esra Ö ÖZER, Assist Prof., Principal investigator, Ankara Medipol Unıversty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289764
- Sponsor's protocol ID
- 7/02/2024/131
- Acronym
- Aromatherapy
- Status last verified
- Oct 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be planned after the study is completed.
Publications
Ozer E, Doner SI, Dag Tuzmen H. The effect of aromatherapy intervention with Bergamot and Grapefruit essential oils on premenstrual syndrome and menstrual symptoms: a randomized controlled trial. BMC Complement Med Ther. 2025 May 1;25(1):162. doi: 10.1186/s12906-025-04857-3.
PubMed 40312670
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on Premenstrual Syndrome and Menstrual Symptoms
- ClinicalTrials.gov ID
- NCT06289764
- Acronym / sponsor ID
- Aromatherapy / 7/02/2024/131
- Conditions
- Premenstrual Syndrome-PMS
- Keywords
- Aromatherapy, Premenstrual syndrome, Menstrual symptom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Esra ÖZERUniversity, hospital or other
- Collaborators
- KTO Karatay University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 20 Apr 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 4 Mar 2024 (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.
Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being.
Premenstrual syndrome (PMS) is a health problem characterized by the periodic occurrence of physical, cognitive, emotional and behavioral symptoms during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is reported that approximately 80-95% of women complain of PMS complaints.
Although the use of aromatherapy in womens health is widespread, there is no study comparing bergamot and grapefruit essential oils. The aim of this study was to determine the effect of aromatherapy with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms.
Detailed description
Aromatherapy is the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being.The fact that aromatherapy is a noninvasive procedure and is easy to use allows aromatherapy to be widely used . Aromatic oils can be applied in four basic ways. These are topical (touch, compress or bath), internal (mouthwash, vaginal or anal suppositories), oral (capsules or dilution in honey, alcohol or diluent) and inhalation (direct or indirect inhalation with or without steam). Essential oils, which can be applied in various ways, can directly reach the neocortex part of the brain through connections from the limbic system to the hypothalamus via odor. As a result of the effect of aromatic oils on the central nervous system, relaxation, sedation or stimulating effects occur, and thanks to the information flow reaching the brain with the stimulation of the central nervous system, the energy blockage in the body is broken and energy is released as a result. The healing process is supported by the balanced spread of the energy flow to the relevant organs, and physical and mental well-being emerges. Aromatherapy is used in many health fields as well as in womens health.
Premenstrual syndrome (PMS) is a health problem characterized by periodic physical, cognitive, emotional and behavioral symptoms that occur periodically during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is stated that approximately 80-95% of women complain of PMS complaints. In studies in the literature, aromatherapy with various essential oils (rose, geranium, sage, lavender) was applied to women complaining of PMS complaints and it was determined that aromatherapy application had both psychological and physical positive effects by stating that depression, anxiety, anxiety, irritability, and pain perception decreased.
Menstrual symptoms are recognized as one of the biggest problems that negatively affect the health status and quality of life among women of reproductive age worldwide. Menstrual symptoms such as dysmenorrhea, heavy menstrual bleeding and mood disorders during the premenstrual period are known to be common in the general population. Menstrual symptoms affect womens activities of daily living and quality of life. In studies in the literature, aromatherapy with various essential oils (rose, sage, ginger) was applied to women with dysmenorrhea, but no study was found in which all menstrual symptoms were measured.
Bergamot (Citrus aurantium bergamia), a small tree belonging to the Rutaceae family among citrus fruits, grows in the Mediterranean region and is especially native to the southern coast of Italy. Bergamot essential oil (BEO) is an essential oil produced by extracting the fruit from the rind by cold pressing procedure or steam distillation. Bergamot essential oil has analgesic, sleep quality enhancing, relaxation, anti-inflammatory and antidepressant effects.
Grapefruit, one of the citrus families with the largest production in the world, is famous for its taste and nutritional value, and grapefruit essential oil has antibacterial, antimicrobial, antiseptic, antidepressant, anti-edema and appetite regulating effects.
Although the use of aromatherapy in womens health is widespread, no study comparing bergamot and grapefruit essential oil has been found. The aim of this study is to determine the effect of aromatherapy application with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sweet almond oil | Placebo comparator | Other: Sweet almond oilPremenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm. |
| Bergamot essential oil | Experimental | Other: Bergamot Essential OilPremenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm |
| Grapefruit essential oil | Experimental | Other: Grapefruit Essential OilPremenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- To be between the ages of 18-35
- Experiencing at least 5 of the pms complaints (self-report)
- Not having respiratory diseases such as asthma and bronchitis (self-report)
- No pregnancy or suspected pregnancy (self-report)
- Not being allergic to any substance (self-report)
Key exclusion criteria (1 listed)
- Under 18, over 35 years of age Not experiencing pms complaints Finding anosmia Presence of respiratory system diseases Allergic symptoms to aromatherapy Being pregnantHaving a chronic disease
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 |
|---|---|---|
| Bergamot Essential OilSelected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles. | Other | Bergamot essential oil |
| Grapefruit Essential OilSelected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles. | Other | Grapefruit essential oil |
| Sweet almond oilSelected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles | Other | Sweet almond oil |
Primary outcome
Premenstrual syndrome scale (PMS)
Time frame: Baseline and three months later
It is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms. A minimum of 44 and a maximum of 220 points can be obtained from the scale. An increase in the score obtained from the scale indicates that the intensity of PMS symptoms increases. In the PMS scale, PMS is considered to be "present" if it exceeds 50% (110) of the total scale score (220).
1 secondary outcome
Menstrual Symptom Scale
Time frame: Baseline and three months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 40312670Ozer E, Doner SI, Dag Tuzmen H. The effect of aromatherapy intervention with Bergamot and Grapefruit essential oils on premenstrual syndrome and menstrual symptoms: a randomized controlled trial. BMC Complement Med Ther. 2025 May 1;25(1):162. doi: 10.1186/s12906-025-04857-3.
- Individual participant dataSharing planned: No. It will be planned after the study is completed.
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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.
Esra Ö ÖZER, Assist Prof. principal investigator
Ankara Medipol Unıversty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bergamot Essential Oil, Grapefruit Essential Oil and Sweet almond oil in people with Premenstrual Syndrome-PMS, run by Esra ÖZER at 1 site in Turkey (Türkiye).
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 6 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: finished, as of the sponsor's last update on 15 Oct 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual syndrome scale (PMS) (time frame: Baseline and three months later). 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 NCT06289764, which also lists 1 linked publication.
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 15 Oct 2024.