Premenstrual SyndromeNCT05823207
Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Symptoms and Quality of Life
A study testing sage essential oil in people with Premenstrual Syndrome and Anxiety, run by Cansu Mine Aydin.
Trial summary
The changes (mood changes, lethargy, irritability, etc.) that gradually disappear with the start of the menstrual period in women are called premenstrual syndrome. Anxiety, irritability, poor concentration, depression, mood swings, lethargy, sleep disturbance, breast tenderness, change in appetite, bloating, headache… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Anxiety
- What is being tested?
- sage essential oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- May 2023to 30 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Getting over 110 points from the PMS scale,
- Experiencing at least five PMS symptoms each month,
- Not having sexual intercourse
- Regular menstruation, (regular menstruation (between 21-35 days) )
- Absence of any chronic disease,
- Not using any method to deal with PMS
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- No known allergic reaction to the essential oil to be used,
- Those who are not bothered by the smell of the essential oil to be used and accept the use of sage essential oil
- Not taking Hormone Replacement Therapy
- Women who agreed to participate in the study were included in the study group.
Who cannot join
- Married
- Allergy,
- Individuals with inconvenient conditions (nausea, dizziness, febrile diseases, high fever, skin or joint inflammation, unknown itching and redness, unknown edema, open wound, cancer, recent operation, intra-abdominal surgery, cyst, appendicitis) ),
- Irregular menstruation,
- Not having regular periods in the last three months,
- Having a psychiatric diagnosis,
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- Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
- Using contraceptive drugs,
- Those with olfactory problems (anosmia)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Syndrome and Quality of Life: A Randomized Controlled Study
The changes (mood changes, lethargy, irritability, etc.) that gradually disappear with the start of the menstrual period in women are called premenstrual syndrome. Anxiety, irritability, poor concentration, depression, mood swings, lethargy, sleep disturbance, breast tenderness, change in appetite, bloating, headache, weight gain, abdominal pain, fatigue, and gastrointestinal symptoms are seen in this syndrome. Safe and effective treatments are needed as these symptoms negatively affect both work and personal lives of women. Some women also turned to therapeutic approaches due to the high side effects of pharmacological treatment. One of these approaches is the aromatherapy method, which is widely used today. Aromatherapy is a therapy aimed at protecting and improving one's physical, mental and psychological health. Traditionally, aromatherapy has been used as one of the non-pharmacological methods for reducing premenstrual symptoms, releasing uterine cramps, and reducing pain and anxiety. Sage oil, with its ester components, regulates the menstrual cycle and hormonal components and alleviates climatic changes and symptoms in menopausal women. It is also recommended to use sage essential oil to reduce uterine tonics and to reduce fluid retention in the premenstrual period. In our country, no study was found in which aromatherapy was performed using sage oil in PMS. It is thought that the study to be conducted in this area will be beneficial in terms of evaluating the effectiveness of a non-pharmacological method in the treatment of PMS.
Read the detailed description
In premenstrual symptoms, psychotropic drugs, hormone therapy or nonsteroidal anti-inflammatory drugs are used as pharmacological methods. Aromatherapy, which is one of the non-pharmacological methods, is preferred to reduce premenstrual symptoms. Aromatherapy through massage and inhalation is commonly used in nursing interventions. Sage has also been used for various human ailments since ancient times. Sage oil regulates the menstrual cycle and hormonal components and is known to alleviate climatic changes and symptoms in menopausal women. The main goal of nursing practices is to ensure the well-being of the individual, family and society, to maintain care, to organize attempts to protect and improve health, to teach coping methods for healing and rehabilitation in case of illness, and is to increases the quality of life.
From this point of view, studies have shown that aromatherapy has an effect on reducing premenstrual symptoms and increasing quality of life. This research, It is thought that it will both create a resource for nurses and contribute to the formation of the necessary evidence for the application of sage oil in aromatherapy in people with PMS.
- Conditions
- Premenstrual Syndrome, Anxiety
- Being tested
- sage essential oil
- Keywords
- premenstrual syndrome, aromatherapy, students, sage oil
- Medical subject headings
- Premenstrual Syndrome, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sage essential oilOther
It will be applied 2 times a day, at the same times, at a distance of 30 cm from the nose for 5 minutes with normal breathing and 3 drops of essential oil by placing a tampon. The PMS scale and the quality of life scale are administered to the participants at the end of the 1st, 2nd and 3rd cycles of the menstrual cycle.
| Study group | Role | What they receive |
|---|---|---|
| Sage essential oil | Experimental | Sage essential oil is applied twice a day for a total of 6 drops for 5 days in each cycle. Receives: Other: sage essential oil |
| control group | No intervention | No application was made to this group. Personal information form and PMS scale and quality of life scale will be applied to this group at the end of each cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form:
It will take 10-15 minutes for the participants to fill out the questionnaire consisting of 33. Students who accept the scent of sage essential oil as a primary outcome measure and have a regular menstrual cycle will participate. A menstrual cycle calendar will be created for the participants
Measured: 1 year
Premenstrual Syndrome Scale (PMSS):
Participants in the study will be asked to fill in this scale. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points 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 the symptoms increases. If the total scale score (220) on the PMS scale exceeds 50% (110), PMS is considered "present".
Measured: 1 year
Secondary outcomes (2)
Premenstrual Syndrome Scale (PMSS):
Participants in the study will be asked to complete this scale in the 1st, 2nd and 3rd menstrual cycles. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points 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 the symptoms increases. PMS is considered "present" if the total scale score (220) on the PMS scale exceeds 50% (110).
Measured: 1 year
SF-36 Quality of Life Scale
Participants in the study will be asked to complete this scale in the 1st, 2nd and 3rd menstrual cycles. The scale consists of eight sub-dimensions: physical function, physical role limitations, emotional role limitations, vitality (life energy), social function, pain, and mental health. and general health perception. A separate score is obtained for each subscale. The SF-36 evaluates the positive as well as the negative aspects of health status. Sub-dimension scores range from 0 to 100. The scores are positive. Increasing score indicates better quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study startMay 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies 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
- The first group will be determined as the experimental group that inhales sage essential oil, and the second group will be determined as the control group. 2 group
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cansu Mine Aydin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cansu Mine Aydin, Kafkas University
- Investigators
- özlem karabulutlu, assoc.dr, Principal investigator, kafkas univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823207
- Sponsor's protocol ID
- KAFKAS-SAG-CMAYDIN-001
- Status last verified
- May 2023
- First submitted
- 8 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Syndrome and Quality of Life: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05823207
- Acronym / sponsor ID
- KAFKAS-SAG-CMAYDIN-001
- Conditions
- Premenstrual Syndrome, Anxiety
- Keywords
- premenstrual syndrome, aromatherapy, students, sage oil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Cansu Mine AydinUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Apr 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.
The changes (mood changes, lethargy, irritability, etc.) that gradually disappear with the start of the menstrual period in women are called premenstrual syndrome. Anxiety, irritability, poor concentration, depression, mood swings, lethargy, sleep disturbance, breast tenderness, change in appetite, bloating, headache, weight gain, abdominal pain, fatigue, and gastrointestinal symptoms are seen in this syndrome. Safe and effective treatments are needed as these symptoms negatively affect both work and personal lives of women. Some women also turned to therapeutic approaches due to the high side effects of pharmacological treatment. One of these approaches is the aromatherapy method, which is widely used today. Aromatherapy is a therapy aimed at protecting and improving one's physical, mental and psychological health. Traditionally, aromatherapy has been used as one of the non-pharmacological methods for reducing premenstrual symptoms, releasing uterine cramps, and reducing pain and anxiety. Sage oil, with its ester components, regulates the menstrual cycle and hormonal components and alleviates climatic changes and symptoms in menopausal women. It is also recommended to use sage essential oil to reduce uterine tonics and to reduce fluid retention in the premenstrual period. In our country, no study was found in which aromatherapy was performed using sage oil in PMS. It is thought that the study to be conducted in this area will be beneficial in terms of evaluating the effectiveness of a non-pharmacological method in the treatment of PMS.
Detailed description
In premenstrual symptoms, psychotropic drugs, hormone therapy or nonsteroidal anti-inflammatory drugs are used as pharmacological methods. Aromatherapy, which is one of the non-pharmacological methods, is preferred to reduce premenstrual symptoms. Aromatherapy through massage and inhalation is commonly used in nursing interventions. Sage has also been used for various human ailments since ancient times. Sage oil regulates the menstrual cycle and hormonal components and is known to alleviate climatic changes and symptoms in menopausal women. The main goal of nursing practices is to ensure the well-being of the individual, family and society, to maintain care, to organize attempts to protect and improve health, to teach coping methods for healing and rehabilitation in case of illness, and is to increases the quality of life.
From this point of view, studies have shown that aromatherapy has an effect on reducing premenstrual symptoms and increasing quality of life. This research, It is thought that it will both create a resource for nurses and contribute to the formation of the necessary evidence for the application of sage oil in aromatherapy in people with PMS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first group will be determined as the experimental group that inhales sage essential oil, and the second group will be determined as the control group. 2 group
| Arm | Type | Receives |
|---|---|---|
| Sage essential oil | Experimental | Other: sage essential oilSage essential oil is applied twice a day for a total of 6 drops for 5 days in each cycle. |
| control group | No intervention | –No application was made to this group. Personal information form and PMS scale and quality of life scale will be applied to this group at the end of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Getting over 110 points from the PMS scale,
- Experiencing at least five PMS symptoms each month,
- Not having sexual intercourse
- Regular menstruation, (regular menstruation (between 21-35 days) )
- Absence of any chronic disease,
Key exclusion criteria (9 listed)
- Married
- Allergy,
- Individuals with inconvenient conditions (nausea, dizziness, febrile diseases, high fever, skin or joint inflammation, unknown itching and redness, unknown edema, open wound, cancer, recent operation, intra-abdominal surgery, cyst, appendicitis) ),
- Irregular menstruation,
- Not having regular periods in the last three months,
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 |
|---|---|---|
| sage essential oilIt will be applied 2 times a day, at the same times, at a distance of 30 cm from the nose for 5 minutes with normal breathing and 3 drops of essential oil by placing a tampon. The PMS scale and the quality of life scale are administered to the participants at the end of the 1st, 2nd and 3rd cycles of the menstrual cycle. | Other | Sage essential oil |
Primary outcome
Personal Information Form:
Time frame: 1 year
It will take 10-15 minutes for the participants to fill out the questionnaire consisting of 33. Students who accept the scent of sage essential oil as a primary outcome measure and have a regular menstrual cycle will participate. A menstrual cycle calendar will be created for the participants
Premenstrual Syndrome Scale (PMSS):
Time frame: 1 year
Participants in the study will be asked to fill in this scale. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points 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 the symptoms increases. If the total scale score (220) on the PMS scale exceeds 50% (110), PMS is considered "present".
2 secondary outcomes
Premenstrual Syndrome Scale (PMSS):
Time frame: 1 year
SF-36 Quality of Life Scale
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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.
özlem karabulutlu, assoc.dr principal investigator
kafkas univesity
Questions about this trial
What is this clinical trial studying?
A study testing sage essential oil in people with Premenstrual Syndrome and Anxiety, run by Cansu Mine Aydin.
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 10 inclusion and 9 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 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 cansu mine aydın, R.A (05529402140, cansumine2236@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form: (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.