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Effect of Lavender Inhalation on Dysmenorrhea

Primary Purpose

Dysmenorrhea

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lavender oil inhalation
Placebo
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dysmenorrhea

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sakarya Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

Lavender inhalation will be administered to this group.

Olive oil will be administered to the placebo group.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
June 13, 2023
Last Updated
August 12, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05995730
Brief Title
Effect of Lavender Inhalation on Dysmenorrhea
Official Title
Effect of Lavender Inhalation on Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Lavender inhalation will be administered to this group.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Olive oil will be administered to the placebo group.
Intervention Type
Other
Intervention Name(s)
Lavender oil inhalation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Olive oil
Intervention Description
Olive oil will be administered to the placebo group. The application will be similar to the experimental group.
Primary Outcome Measure Information:
Title
Dysmenorrhea Symptom Assessment Form
Description
Form consists of questions about dysmenorrhea symptoms in the participants.As the score obtained from the form increases, the severity of the symptoms increases.
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.
Title
Numerical Pain Scale
Description
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
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gönül Kurt, Assist. Prof
Phone
90 (312) 304
Ext
3902
Email
gonul.kurt@sbu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Gönül Kurt, Assist. Prof
Facility Information:
Facility Name
Sakarya Training and Research Hospital
City
Sakarya
ZIP/Postal Code
54000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gönül Kurt, Associate professor
Phone
90 (312) 304
Ext
3902
Email
gonul.kurt@sbu.edu.tr

12. IPD Sharing Statement

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Effect of Lavender Inhalation on Dysmenorrhea

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