Effect of Lavender Inhalation on Dysmenorrhea

August 12, 2023 updated by: Saglik Bilimleri Universitesi

Effect of Lavender Inhalation on Primary Dysmenorrhea

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Gönül Kurt, Assist. Prof

Study Locations

  • Turkey
      • Sakarya, Turkey, 54000
        • Recruiting
        • Sakarya Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Lavender inhalation will be administered to this group.
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 Comparator: Placebo group
Olive oil will be administered to the placebo group.
Other: Placebo
Olive oil will be administered to the placebo group. The application will be similar to the experimental group.
Other Names:
  • Olive oil

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

August 12, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16214662/050.01.04/130

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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