Clinical trial NCT05823207: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Syndrome
Anxiety
Keywords: premenstrual syndrome
aromatherapy
students
sage oil
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Personal Information Form:
timeFrame: 1 year
measure: Premenstrual Syndrome Scale (PMSS):
timeFrame: 1 year
Secondary outcomes:
measure: Premenstrual Syndrome Scale (PMSS):
timeFrame: 1 year
measure: SF-36 Quality of Life Scale
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: kafkas univesity
name: özlem karabulutlu, assoc.dr
role: PRINCIPAL_INVESTIGATOR
References: