Effect of Lavender Inhalation on Dysmenorrhea

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Recruiting
CT.gov ID
NCT05995730
Collaborator
(none)
51
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2
16.4
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Lavender oil inhalation
  • Other: Placebo
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Effect of Lavender Inhalation on Primary Dysmenorrhea
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
May 15, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Dysmenorrhea Symptom Assessment Form [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.

    2. Numerical Pain Scale [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 30 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sakarya Training and Research Hospital Sakarya Turkey 54000

    Sponsors and Collaborators

    • Saglik Bilimleri Universitesi

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saglik Bilimleri Universitesi
    ClinicalTrials.gov Identifier:
    NCT05995730
    Other Study ID Numbers:
    • 16214662/050.01.04/130
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 16, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2023