Effect of Lavender Inhalation on Dysmenorrhea

NCT05995730 | Unknown

• 1 other identifier: 16214662/050.01.04/130
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Experimental group

EXPERIMENTAL

Lavender inhalation will be administered to this group.

Other: Lavender oil inhalation

Placebo group

PLACEBO COMPARATOR

Olive oil will be administered to the placebo group.

Other: Placebo

Interventions

Lavender oil inhalation OTHER

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.

Experimental group

Placebo OTHER

Olive oil will be administered to the placebo group. The application will be similar to the experimental group.

Also known as: Olive oil

Placebo group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sakarya Training and Research Hospital

Sakarya, 54000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Gönül Kurt, Assist. Prof

CONTACT

90 (312) 304; gonul.kurt@sbu.edu.tr

Gönül Kurt, Assist. Prof

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: August 16, 2023
• Study Start: January 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: May 15, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-06

Locations

TU (1)