DysmenorrheaNCT05995730
Effect of Lavender Inhalation on Dysmenorrhea
A study testing Lavender oil inhalation in people with Dysmenorrhea, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of lavender inhalation on primary dysmenorrhea and its symptoms. 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
- Dysmenorrhea
- What is being tested?
- Lavender oil inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 15 May 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
- Having primary dysmenorrhea (degrees II and III),
- Single,
- Who have never been pregnant before,
- Having a regular menstrual cycle
- Without any genital organ disorder (such as fibroids, fibroadenoma, endometriosis, metrorrhagia, ovarian cyst, pelvic inflammatory disease, chronic pelvic pain, other pelvic pathologies)
- Not using contraceptive method,
- Having a normal sense of smell
- People who can smell odors and are not allergic to odors will be included in the study.
Who cannot join
- Married,
- Having a disease that causes dysmenorrhea,
- Regularly using a pharmacological and non-pharmacological method to relieve
- Dysmenorrhea pain during the study,
- Having a previous or unconcluded pregnancy,
- Having a chronic disease (diabetes, endometriosis, uterine congenital anomalies, epilepsy, etc.),
- Using drugs that affect the menstrual cycle or dysmenorrhea,
- Persons who fill in the data collection form incompletely or not at all will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Gönül Kurt, Assist. Prof contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya Training and Research Hospital
Sakarya, 54000
Gönül Kurt, Associate professor, 90 (312) 304 ext. 3902, gonul.kurt@sbu.edu.tr
About this study
Official title: Effect of Lavender Inhalation on Primary Dysmenorrhea
This study was planned to determine the effect of lavender inhalation on primary dysmenorrhea and its symptoms.
Read the detailed description
The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (lavender) and control (placebo) groups.
- Conditions
- Dysmenorrhea
- Being tested
- Lavender oil inhalation, Placebo
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender oil inhalationOther
Lavender inhalation will be administered to this group. Participants will be asked to drop three drops of lavender oil solution on a small piece of cotton on the 1st, 2nd, and 3rd days of their first menstrual bleeding after enrollment in the study, hold it 7-10 cm from their noses, and sniff for 5 minutes. Participants will be asked to apply this application immediately after the onset of dysmenorrhea pain on the first day of their menstruation and to continue regularly every 8 hours for the first three days of menstrual bleeding. Participants will be asked to apply this application in the same way in two consecutive menstrual cycles and the participants will be followed in this process.
PlaceboOther
Also called Olive oil
Olive oil will be administered to the placebo group. The application will be similar to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Lavender inhalation will be administered to this group. Receives: Other: Lavender oil inhalation |
| Placebo group | Placebo comparator | Olive oil will be administered to the placebo group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysmenorrhea Symptom Assessment Form
Form consists of questions about dysmenorrhea symptoms in the participants.As the score obtained from the form increases, the severity of the symptoms increases.
Measured: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
Numerical Pain Scale
It will be applied to evaluate the level of dysmenorrhea pain. Participants will be asked to rate their pain level from 0 to 10. As the score increases, the level of pain increases
Measured: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Jan 2023
- Primary completion15 Dec 2023 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995730
- Sponsor's protocol ID
- 16214662/050.01.04/130
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lavender Inhalation on Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05995730
- Acronym / sponsor ID
- 16214662/050.01.04/130
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 16 Aug 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.
This study was planned to determine the effect of lavender inhalation on primary dysmenorrhea and its symptoms.
Detailed description
The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (lavender) and control (placebo) groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Lavender oil inhalationLavender inhalation will be administered to this group. |
| Placebo group | Placebo comparator | Other: PlaceboOlive oil will be administered to the placebo group. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Having primary dysmenorrhea (degrees II and III),
- Single,
- Who have never been pregnant before,
- Having a regular menstrual cycle
- Without any genital organ disorder (such as fibroids, fibroadenoma, endometriosis, metrorrhagia, ovarian cyst, pelvic inflammatory disease, chronic pelvic pain, other pelvic pathologies)
Key exclusion criteria (8 listed)
- Married,
- Having a disease that causes dysmenorrhea,
- Regularly using a pharmacological and non-pharmacological method to relieve
- Dysmenorrhea pain during the study,
- Having a previous or unconcluded pregnancy,
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 |
|---|---|---|
| Lavender oil inhalationLavender inhalation will be administered to this group. Participants will be asked to drop three drops of lavender oil solution on a small piece of cotton on the 1st, 2nd, and 3rd days of their first menstrual bleeding after enrollment in the study, hold it 7-10 cm from their noses, and sniff for 5 minutes. Participants will be asked to apply this application immediately after the onset of dysmenorrhea pain on the first day of their menstruation and to continue regularly every 8 hours for the first three days of menstrual bleeding. Participants will be asked to apply this application in the same way in two consecutive menstrual cycles and the participants will be followed in this process. | Other | Experimental group |
| PlaceboAlso: Olive oilOlive oil will be administered to the placebo group. The application will be similar to the experimental group. | Other | Placebo group |
Primary outcome
Dysmenorrhea Symptom Assessment Form
Time frame: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
Form consists of questions about dysmenorrhea symptoms in the participants.As the score obtained from the form increases, the severity of the symptoms increases.
Numerical Pain Scale
Time frame: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
It will be applied to evaluate the level of dysmenorrhea pain. Participants will be asked to rate their pain level from 0 to 10. As the score increases, the level of pain increases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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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.
Gönül Kurt, Assist. Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender oil inhalation in people with Dysmenorrhea, run by Saglik Bilimleri Universitesi 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 8 inclusion and 8 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 16 Aug 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. 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 Gönül Kurt, Assist. Prof (90 (312) 304 ext. 3902, gonul.kurt@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysmenorrhea Symptom Assessment Form (time frame: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.). 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 16 Aug 2023.