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Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Symptoms and Quality of Life

Primary Purpose

Premenstrual Syndrome, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sage essential oil
Sponsored by
Cansu Mine Aydin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring premenstrual syndrome, aromatherapy, students, sage oil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Getting over 110 points from the PMS scale, Experiencing at least five PMS symptoms each month, Not having sexual intercourse Regular menstruation, (regular menstruation (between 21-35 days) ) Absence of any chronic disease, Not using any method to deal with PMS No known allergic reaction to the essential oil to be used, Those who are not bothered by the smell of the essential oil to be used and accept the use of sage essential oil Not taking Hormone Replacement Therapy Women who agreed to participate in the study were included in the study group. Exclusion Criteria: Married Allergy, Individuals with inconvenient conditions (nausea, dizziness, febrile diseases, high fever, skin or joint inflammation, unknown itching and redness, unknown edema, open wound, cancer, recent operation, intra-abdominal surgery, cyst, appendicitis) ), Irregular menstruation, Not having regular periods in the last three months, Having a psychiatric diagnosis, Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.) Using contraceptive drugs, Those with olfactory problems (anosmia)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Sage essential oil

    control group

    Arm Description

    Sage essential oil is applied twice a day for a total of 6 drops for 5 days in each cycle.

    No application was made to this group. Personal information form and PMS scale and quality of life scale will be applied to this group at the end of each cycle.

    Outcomes

    Primary Outcome Measures

    Personal Information Form:
    It will take 10-15 minutes for the participants to fill out the questionnaire consisting of 33. Students who accept the scent of sage essential oil as a primary outcome measure and have a regular menstrual cycle will participate. A menstrual cycle calendar will be created for the participants
    Premenstrual Syndrome Scale (PMSS):
    Participants in the study will be asked to fill in this scale. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points and a maximum of 220 points can be obtained from the scale. An increase in the score obtained from the scale indicates that the intensity of the symptoms increases. If the total scale score (220) on the PMS scale exceeds 50% (110), PMS is considered "present".

    Secondary Outcome Measures

    Premenstrual Syndrome Scale (PMSS):
    Participants in the study will be asked to complete this scale in the 1st, 2nd and 3rd menstrual cycles. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points and a maximum of 220 points can be obtained from the scale. An increase in the score obtained from the scale indicates that the intensity of the symptoms increases. PMS is considered "present" if the total scale score (220) on the PMS scale exceeds 50% (110).
    SF-36 Quality of Life Scale
    Participants in the study will be asked to complete this scale in the 1st, 2nd and 3rd menstrual cycles. The scale consists of eight sub-dimensions: physical function, physical role limitations, emotional role limitations, vitality (life energy), social function, pain, and mental health. and general health perception. A separate score is obtained for each subscale. The SF-36 evaluates the positive as well as the negative aspects of health status. Sub-dimension scores range from 0 to 100. The scores are positive. Increasing score indicates better quality of life.

    Full Information

    First Posted
    April 8, 2023
    Last Updated
    May 6, 2023
    Sponsor
    Cansu Mine Aydin
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05823207
    Brief Title
    Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Symptoms and Quality of Life
    Official Title
    Effect of Sage Essential Oil Inhalation Aromatherapy on Premenstrual Syndrome and Quality of Life: A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cansu Mine Aydin

    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
    The changes (mood changes, lethargy, irritability, etc.) that gradually disappear with the start of the menstrual period in women are called premenstrual syndrome. Anxiety, irritability, poor concentration, depression, mood swings, lethargy, sleep disturbance, breast tenderness, change in appetite, bloating, headache, weight gain, abdominal pain, fatigue, and gastrointestinal symptoms are seen in this syndrome. Safe and effective treatments are needed as these symptoms negatively affect both work and personal lives of women. Some women also turned to therapeutic approaches due to the high side effects of pharmacological treatment. One of these approaches is the aromatherapy method, which is widely used today. Aromatherapy is a therapy aimed at protecting and improving one's physical, mental and psychological health. Traditionally, aromatherapy has been used as one of the non-pharmacological methods for reducing premenstrual symptoms, releasing uterine cramps, and reducing pain and anxiety. Sage oil, with its ester components, regulates the menstrual cycle and hormonal components and alleviates climatic changes and symptoms in menopausal women. It is also recommended to use sage essential oil to reduce uterine tonics and to reduce fluid retention in the premenstrual period. In our country, no study was found in which aromatherapy was performed using sage oil in PMS. It is thought that the study to be conducted in this area will be beneficial in terms of evaluating the effectiveness of a non-pharmacological method in the treatment of PMS.
    Detailed Description
    In premenstrual symptoms, psychotropic drugs, hormone therapy or nonsteroidal anti-inflammatory drugs are used as pharmacological methods. Aromatherapy, which is one of the non-pharmacological methods, is preferred to reduce premenstrual symptoms. Aromatherapy through massage and inhalation is commonly used in nursing interventions. Sage has also been used for various human ailments since ancient times. Sage oil regulates the menstrual cycle and hormonal components and is known to alleviate climatic changes and symptoms in menopausal women. The main goal of nursing practices is to ensure the well-being of the individual, family and society, to maintain care, to organize attempts to protect and improve health, to teach coping methods for healing and rehabilitation in case of illness, and is to increases the quality of life. From this point of view, studies have shown that aromatherapy has an effect on reducing premenstrual symptoms and increasing quality of life. This research, It is thought that it will both create a resource for nurses and contribute to the formation of the necessary evidence for the application of sage oil in aromatherapy in people with PMS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premenstrual Syndrome, Anxiety
    Keywords
    premenstrual syndrome, aromatherapy, students, sage oil

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The first group will be determined as the experimental group that inhales sage essential oil, and the second group will be determined as the control group. 2 group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sage essential oil
    Arm Type
    Experimental
    Arm Description
    Sage essential oil is applied twice a day for a total of 6 drops for 5 days in each cycle.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    No application was made to this group. Personal information form and PMS scale and quality of life scale will be applied to this group at the end of each cycle.
    Intervention Type
    Other
    Intervention Name(s)
    sage essential oil
    Intervention Description
    It will be applied 2 times a day, at the same times, at a distance of 30 cm from the nose for 5 minutes with normal breathing and 3 drops of essential oil by placing a tampon. The PMS scale and the quality of life scale are administered to the participants at the end of the 1st, 2nd and 3rd cycles of the menstrual cycle.
    Primary Outcome Measure Information:
    Title
    Personal Information Form:
    Description
    It will take 10-15 minutes for the participants to fill out the questionnaire consisting of 33. Students who accept the scent of sage essential oil as a primary outcome measure and have a regular menstrual cycle will participate. A menstrual cycle calendar will be created for the participants
    Time Frame
    1 year
    Title
    Premenstrual Syndrome Scale (PMSS):
    Description
    Participants in the study will be asked to fill in this scale. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points and a maximum of 220 points can be obtained from the scale. An increase in the score obtained from the scale indicates that the intensity of the symptoms increases. If the total scale score (220) on the PMS scale exceeds 50% (110), PMS is considered "present".
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Premenstrual Syndrome Scale (PMSS):
    Description
    Participants in the study will be asked to complete this scale in the 1st, 2nd and 3rd menstrual cycles. Women with premenstrual syndrome will be included in the study. The total score is obtained from the sum of the scores from all sub-dimensions. A minimum of 44 points and a maximum of 220 points can be obtained from the scale. An increase in the score obtained from the scale indicates that the intensity of the symptoms increases. PMS is considered "present" if the total scale score (220) on the PMS scale exceeds 50% (110).
    Time Frame
    1 year
    Title
    SF-36 Quality of Life Scale
    Description
    Participants in the study will be asked to complete this scale in the 1st, 2nd and 3rd menstrual cycles. The scale consists of eight sub-dimensions: physical function, physical role limitations, emotional role limitations, vitality (life energy), social function, pain, and mental health. and general health perception. A separate score is obtained for each subscale. The SF-36 evaluates the positive as well as the negative aspects of health status. Sub-dimension scores range from 0 to 100. The scores are positive. Increasing score indicates better quality of life.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Getting over 110 points from the PMS scale, Experiencing at least five PMS symptoms each month, Not having sexual intercourse Regular menstruation, (regular menstruation (between 21-35 days) ) Absence of any chronic disease, Not using any method to deal with PMS No known allergic reaction to the essential oil to be used, Those who are not bothered by the smell of the essential oil to be used and accept the use of sage essential oil Not taking Hormone Replacement Therapy Women who agreed to participate in the study were included in the study group. Exclusion Criteria: Married Allergy, Individuals with inconvenient conditions (nausea, dizziness, febrile diseases, high fever, skin or joint inflammation, unknown itching and redness, unknown edema, open wound, cancer, recent operation, intra-abdominal surgery, cyst, appendicitis) ), Irregular menstruation, Not having regular periods in the last three months, Having a psychiatric diagnosis, Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.) Using contraceptive drugs, Those with olfactory problems (anosmia)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    cansu mine aydın, R.A
    Phone
    05529402140
    Email
    cansumine2236@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    özlem karabulutlu, assoc.dr
    Phone
    05321781081
    Email
    okarabulutlu@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    özlem karabulutlu, assoc.dr
    Organizational Affiliation
    kafkas univesity
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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