Effect of Lavender Inhalation on Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

Effect of Lavender Inhalation on Primary Dysmenorrhea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995730
• Other study ID #: 16214662/050.01.04/130
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: June 2023
• Source: Saglik Bilimleri Universitesi
• Contact: Gönül Kurt, Assist. Prof
• Phone: 90 (312) 304
• Email: gonul.kurt[@]sbu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was planned to determine the effect of lavender inhalation on primary dysmenorrhea and its symptoms.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: May 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Other:
• Lavender oil inhalation
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.
• Placebo
Olive oil will be administered to the placebo group. The application will be similar to the experimental group.

Locations

Country	Name	City	State
Turkey	Sakarya Training and Research Hospital	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
Primary	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	to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.