Premenstrual SyndromeNCT05599594
Premenstrual Symptoms and Aromatherapy
A study testing Aromatherapy in people with Premenstrual Syndrome and Aromatherapy, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Aromatherapy is the science of using high concentrated essential oils or essences with distilled high concentration of plants to take advantage of therapeutic properties '' . Essential oils or essences are obtained from various parts of plants (root, leaf, flower, shell, fruit) and therapeutically used for physical… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Aromatherapy
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 30 Jul 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Premenstrual is at least 5 of the complaints living (self-notice),
- Non-respiratory disease such as asthma, bronchitis (self-notice),
- Not allergic to fat to be used (self-notice),
- Pregnancy or pregnancy doubt (self-notice),
- Diabetes, hypertension without a systemic discomfort (self-notice)
Who cannot join
- Premenstrual has not experienced complaints,
- Using cigarettes or alcohol,
- With chronic discomfort (respiratory diseases),
- Pregnancy suspected or conceived,
- With a systemic discomfort such as diabetes, hypertension,
- Individuals who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
KTO Karatay University
Konya, 42000
Şerife İrem DÖNER
About this study
Official title: Effect of Neroli and Lemongrass Oils With Premenstrual Symptoms and Effect on Quality of Life: Randomized Controlled Research
Aromatherapy is the science of using high concentrated essential oils or essences with distilled high concentration of plants to take advantage of therapeutic properties '' . Essential oils or essences are obtained from various parts of plants (root, leaf, flower, shell, fruit) and therapeutically used for physical and psychological favors. The aromatherapine is a noninvasive process and the convenience of use allows the widespread use of aromatherapy. Aromatic oils can be applied in four basic ways. These are topical (tap, compressed or bath), internal (mouthwash, vaginal or anal wick), mouth (with capsules or honey, alcohol or diluent) and inhalation (inhalation directly or indirectly, steam or vapor ) is the way . Volatile oils that can be applied in various means can reach the neocortex part of the brain directly with the links to the hypothalamus from the limbic system. As a result of the impact of aromatic oils on the central nervous system, relief, sedation or stimulating effects are formed and the energy blockage in the body is broken, due to the information stream reaching the brain with the warning of the central nervous system and the resulting energy is exposed. The improvement process is supported by its exposed energy stream in a balanced way of the relevant organs, and the state of physical and spiritual goodness is emerged. Aromatherapy is also used in the field of women's health as well as many health areas.
Read the detailed description
Premenstrual syndrome is a health problem characterized by mitigation of symptoms in several days after the beginning of menstruals, or after the beginning of menstruals, which occurs in the Luteal phase of menstrual cycle in the luteal phase . About 80-95% of women complained of premenstrual syndrome complaints. This ratio is affected by physical, cognitive, emotional and behavioral symptoms in different occupational groups in serious dimension, it can negatively affect life from business life to family life, and when it is considered to be repeated each month, the quality of life is negatively affected. In this reason the premenstrual symptoms The minimization of complaints and minimizing complaints constitutes a state of need.
In the studies involved in the literature, women complaining about Premenstrual Syndrome complaints were applied to various essential oils (Rose, Sardinia, Sage, Lavender) aromatherapy and stated that depression, anxiety, anxiety, irritability pain perception decreased by both psychological and physical positive effects.
In Turkey, the trend of traditional and complementary medicine is increasing day by day. However, aromatherapy practices are common in Turkey as well as aromatherapy practices in the world. The aromatic oils are diluted and ready to use are a method in pharmacies, as well as in pharmacies, as well as people want to use and use. The cost of ready-to-use aromatic oils will provide the treatment option to women in the light of new evidence in line with the fact that it is cheap and easily accessible to the study .
- Conditions
- Premenstrual Syndrome, Aromatherapy
- Being tested
- Aromatherapy
- Keywords
- Aromatherapy, Premenstrual symptom, Quality of life
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
6 drops of aromatic oils used by the researcher will be dripped by the aromatic oils to take the fragrance by inhalation for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Neroli oil | Experimental | Neroli oil improves the quality of life by reducing premenstrual symptoms with relaxing and calming effect. Receives: Other: Aromatherapy |
| Lemongrass oil | Experimental | Lemongrass oil improves the quality of life by reducing premenstrual symptoms with relaxing and calming effect. Receives: Other: Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
A questionnaire with 12 questions was created by the researchers. The filling time of the participants is 5-6 minutes.
Measured: 1 year
Premenstrual Syndrome Scale
Participants in the study will be asked to fill in this scale in the pre-test. Women with premenstrual syndrome will be included in the study.The application of the premenstrual syndrome scale is made by evaluating the person retrospectively, taking into account the "being in the period one week before the period". The total score is obtained from the sum of the scores from all sub-dimensions. 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 an increase in the intensity of the symptoms. If the total scale score (220) exceeds 50% (110) in the PMS scale, PMS is considered as "present".
Measured: 1 year
Secondary outcomes (2)
Scale for Coping With Premenstrual Symptoms
Participants will be asked to fill in this scale both in the pretest and the posttest.No evaluation is made on the total score of the Scale for Coping with Premenstrual Symptoms. As the score obtained from the sub-dimensions of the scale increases, coping with premenstrual symptoms increases. The scale structure consisting of thirty-two items explains 38.9% of the variance. In addition, the sub-dimensions of the scale are in a significant relationship with each other, and the correlation coefficients range from 0.188 to 0.518. Cronbach's alpha safety coefficients of the sub-dimensions of the Turkish version of PSSS were ''harm avoidance-0.88'', ''awareness and acceptance of premenstrual changes -0.89'', ''adapting energy -0.75'', ''self-care-0.83''. ' is 'communication-0.86''.
Measured: 1 year
SF-36 Quality of Life Scale
Participants will be asked to fill in this scale both in the pretest and the posttest.The scale consists of eight sub-dimensions for physical function, physical role limitations, emotional role limitations, vitality (life energy), social function, pain, mental health and general perception of health. A separate score is obtained for each subscale. SF-36 evaluates the positive as well as the negative aspects of the health condition. Sub-dimension scores range from 0 to 100. Scores are positively oriented. 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 posted31 Oct 2022
- Study start15 Dec 2023 (estimated)
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Jul 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
- 3 groups will be formed from the students identified with the symptoms of premenstrual syndrome. 1.Gruba Neroli, 2.Gruba Lemongrass, to Group 3 (Placebo Group) will be given water vapor and the states of premenstrual syndrome among the groups and the status of premenstrual symptoms will be evaluated. Pre-process pre-test will be applied to all groups. After each application will be tested again. The final test will be applied to each participant's first day of menstruation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Füsun SUNAR, Associate Professor, Principal investigator, Kto Karatay Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599594
- Sponsor's protocol ID
- Karataysid
- Status last verified
- Dec 2022
- First submitted
- 26 Apr 2022
- Last updated
- 26 Oct 2023
- Results posted
- 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 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neroli and Lemongrass Oils With Premenstrual Symptoms and Effect on Quality of Life: Randomized Controlled Research
- ClinicalTrials.gov ID
- NCT05599594
- Acronym / sponsor ID
- Karataysid
- Conditions
- Premenstrual Syndrome, Aromatherapy
- Keywords
- Aromatherapy, Premenstrual symptom, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 31 Oct 2022 (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 high concentrated essential oils or essences with distilled high concentration of plants to take advantage of therapeutic properties '' . Essential oils or essences are obtained from various parts of plants (root, leaf, flower, shell, fruit) and therapeutically used for physical and psychological favors. The aromatherapine is a noninvasive process and the convenience of use allows the widespread use of aromatherapy. Aromatic oils can be applied in four basic ways. These are topical (tap, compressed or bath), internal (mouthwash, vaginal or anal wick), mouth (with capsules or honey, alcohol or diluent) and inhalation (inhalation directly or indirectly, steam or vapor ) is the way . Volatile oils that can be applied in various means can reach the neocortex part of the brain directly with the links to the hypothalamus from the limbic system. As a result of the impact of aromatic oils on the central nervous system, relief, sedation or stimulating effects are formed and the energy blockage in the body is broken, due to the information stream reaching the brain with the warning of the central nervous system and the resulting energy is exposed. The improvement process is supported by its exposed energy stream in a balanced way of the relevant organs, and the state of physical and spiritual goodness is emerged. Aromatherapy is also used in the field of women's health as well as many health areas.
Detailed description
Premenstrual syndrome is a health problem characterized by mitigation of symptoms in several days after the beginning of menstruals, or after the beginning of menstruals, which occurs in the Luteal phase of menstrual cycle in the luteal phase . About 80-95% of women complained of premenstrual syndrome complaints. This ratio is affected by physical, cognitive, emotional and behavioral symptoms in different occupational groups in serious dimension, it can negatively affect life from business life to family life, and when it is considered to be repeated each month, the quality of life is negatively affected. In this reason the premenstrual symptoms The minimization of complaints and minimizing complaints constitutes a state of need.
In the studies involved in the literature, women complaining about Premenstrual Syndrome complaints were applied to various essential oils (Rose, Sardinia, Sage, Lavender) aromatherapy and stated that depression, anxiety, anxiety, irritability pain perception decreased by both psychological and physical positive effects.
In Turkey, the trend of traditional and complementary medicine is increasing day by day. However, aromatherapy practices are common in Turkey as well as aromatherapy practices in the world. The aromatic oils are diluted and ready to use are a method in pharmacies, as well as in pharmacies, as well as people want to use and use. The cost of ready-to-use aromatic oils will provide the treatment option to women in the light of new evidence in line with the fact that it is cheap and easily accessible to the study .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 3 groups will be formed from the students identified with the symptoms of premenstrual syndrome. 1.Gruba Neroli, 2.Gruba Lemongrass, to Group 3 (Placebo Group) will be given water vapor and the states of premenstrual syndrome among the groups and the status of premenstrual symptoms will be evaluated. Pre-process pre-test will be applied to all groups. After each application will be tested again. The final test will be applied to each participant's first day of menstruation.
| Arm | Type | Receives |
|---|---|---|
| Neroli oil | Experimental | Other: AromatherapyNeroli oil improves the quality of life by reducing premenstrual symptoms with relaxing and calming effect. |
| Lemongrass oil | Experimental | Other: AromatherapyLemongrass oil improves the quality of life by reducing premenstrual symptoms with relaxing and calming effect. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premenstrual is at least 5 of the complaints living (self-notice),
- Non-respiratory disease such as asthma, bronchitis (self-notice),
- Not allergic to fat to be used (self-notice),
- Pregnancy or pregnancy doubt (self-notice),
- Diabetes, hypertension without a systemic discomfort (self-notice)
Key exclusion criteria (6 listed)
- Premenstrual has not experienced complaints,
- Using cigarettes or alcohol,
- With chronic discomfort (respiratory diseases),
- Pregnancy suspected or conceived,
- With a systemic discomfort such as diabetes, hypertension,
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 |
|---|---|---|
| Aromatherapy6 drops of aromatic oils used by the researcher will be dripped by the aromatic oils to take the fragrance by inhalation for 30 minutes. | Other | Lemongrass oil, Neroli oil |
Primary outcome
Personal Information Form
Time frame: 1 year
A questionnaire with 12 questions was created by the researchers. The filling time of the participants is 5-6 minutes.
Premenstrual Syndrome Scale
Time frame: 1 year
Participants in the study will be asked to fill in this scale in the pre-test. Women with premenstrual syndrome will be included in the study.The application of the premenstrual syndrome scale is made by evaluating the person retrospectively, taking into account the "being in the period one week before the period". The total score is obtained from the sum of the scores from all sub-dimensions. 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 an increase in the intensity of the symptoms. If the total scale score (220) exceeds 50% (110) in the PMS scale, PMS is considered as "present".
2 secondary outcomes
Scale for Coping With Premenstrual Symptoms
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 26 Oct 2023.
- Individual participant dataSharing planned: No
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THE EFFECT OF A REFLEXOLOGY PROGRAM ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT
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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.
Füsun SUNAR, Associate Professor principal investigator
Kto Karatay Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Premenstrual Syndrome and Aromatherapy, run by KTO Karatay University 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 5 inclusion and 6 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 26 Oct 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 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. 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 Hafize DAĞ TÜZMEN, Phd, Student Nursing (05357446142, hafize.dag.tuzmen@karatay.edu.tr), 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 26 Oct 2023; AzTrials last refreshed its copy on 2 Nov 2026.