Menoupausal Symptoms and Aromatherapy

Sponsor
KTO Karatay University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05677698
Collaborator
(none)
90
1
3
1.1
80.6

Study Details

Study Description

Brief Summary

Aromatherapy is "highly distilled herbs distilled to take advantage of their therapeutic properties".

is the science of using concentrated essential oils or essences".Essential oils or essences are obtained from various parts of plants (root, leaves, flowers, bark, fruit) and used therapeutically for physical and psychological well-being. The fact that aromatherapy is a noninvasive procedure and its ease of use allows for widespread use of aromatherapy. Aromatic oils can be applied in four basic ways. These include topical (tap, compress, or bath), internal (mouthwash, vaginal, or anal suppository), oral (with capsules or reconstitution in honey, alcohol, or diluent), and inhalation (direct or indirect, with or without steam, inhalation). ). Essential oils, which can be applied in various ways, can directly reach the neocortex part of the brain through connections extending from the limbic system to the hypothalamus via scent.

Condition or Disease Intervention/Treatment Phase
  • Other: Peppermint Oil
  • Other: Lemon Oil
  • Other: plasebo
N/A

Detailed Description

As a result of the effect of aromatic oils on the central nervous system, relaxation, sedation or stimulating effects occur and the information flow reaching the brain with the stimulation of the central nervous system.

Thanks to this, the energy blockage in the body is broken and as a result, energy is released. With the balanced distribution of the energy flow to the relevant organs, the healing process is supported, and physical and mental well-being emerges . Aromatherapy is used in many health fields as well as women's health. Menopause is a process in which physiological, psychological and hormonal changes occur in the life of all women . The World Health Organization defines menopause as "the permanent cessation of menstruation with loss of ovarian activity" . In addition to physical symptoms such as hot flashes, sweating, headache, low libido, fatigue, sleep disorders, palpitations, which occur as a result of the decrease in estrogen and progesterone hormone secretion and its end over time, psychological symptoms such as anxiety, depression and mood disorders are frequently encountered . Due to the increase in the number of women in the menopausal period in the world, it is important to reduce menopausal complaints and improve women's health.Studies have shown that aromatherapy is a complementary method used in a wide variety of situations to reduce physiological and psychological symptoms . It is stated that menopausal symptoms decrease in women who smell lavender aroma during menopause . It is important that the symptoms seen during menopause, which is an important part of a woman's life, are reduced and that women can spend this process more comfortably. While the age at menopause is in the range of 50-51 years worldwide, it is reported that the age of menopause in our country is between the ages of 47-49 . From this point of view, women spend about one third of their lives during and after menopause. The trend towards traditional and complementary medicine is increasing day by day in our country. However, in addition to the widespread use of aromatherapy in the world, aromatherapy practices are not common in our country. Diluted and ready-to-use forms of aromatic oils are not only available in pharmacies and herbalists, but also a method that people are curious about and want to use. The fact that the cost of ready-to-use aromatic oils is cheaper than drugs and easily accessible will provide women with a treatment option in the light of new evidence in line with the conduct of the study. In studies in the literature, it is stated that lavender, rose, geranium, and citrus oils are massaged to women in the menopausal period and provide mental and physical relaxation. Therefore, in our study, the use of Peppermint and Lemon oils to reduce the symptoms of menopausal women and increase their psychosocial well-being. is planned. Peppermint (Mentha Piperita) oil has analgesic, immune system strengthening, antispasmodic, antipyretic, anti-nausea and vomiting, anesthetic, helps concentration, increases self-confidence and creative thoughts, and Lemon (Citrus Lemon) oil is analgesic, immune-enhancing, antipyretic. It is thought that it can help relieve the psychological and physiological complaints of women in the menopausal period due to its properties such as helping constipation, reducing nausea and vomiting, increasing sleep quality, relieving stress and antidepressant. For this reason, it is planned to use Peppermint and Lemon oils in our study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Massage will be done for 4 weeks and 2 times a week (8 massages will be given to a person in total). Experimental groups: The researcher will add 2 drops of aromatic oil to 5 cc almond oil and give hand and arm massage to the participants for 30 minutes. Peppermint oil will be used in the first experimental group, lemon oil in the second experimental group and only almond oil in the control group. The fragrance to be used before starting the application will be given to the women by giving them a sniff.Placebo Group: Hand and arm massage will be performed for 30 minutes by the researcher using only almond oil. Three groups will be formed from women with menopausal symptoms. 1st group will be given a massage with Mint, 2nd group Lemon, 3rd group (placebo group-almond oil) and menopausal symptoms, happiness, peace and aging anxiety symptoms will be evaluated between the groups. All groups will be pre-tested before the procedure. 4. At the end of the massage, the test will be repeated.Massage will be done for 4 weeks and 2 times a week (8 massages will be given to a person in total). Experimental groups: The researcher will add 2 drops of aromatic oil to 5 cc almond oil and give hand and arm massage to the participants for 30 minutes. Peppermint oil will be used in the first experimental group, lemon oil in the second experimental group and only almond oil in the control group. The fragrance to be used before starting the application will be given to the women by giving them a sniff.Placebo Group: Hand and arm massage will be performed for 30 minutes by the researcher using only almond oil. Three groups will be formed from women with menopausal symptoms. 1st group will be given a massage with Mint, 2nd group Lemon, 3rd group (placebo group-almond oil) and menopausal symptoms, happiness, peace and aging anxiety symptoms will be evaluated between the groups. All groups will be pre-tested before the procedure. 4. At the end of the massage, the test will be repeated.
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
The Effect of Aromatherapy With Massage Menopausal Symptoms, Happiness, Peace, and Anxiety in Old Age
Actual Study Start Date :
Dec 27, 2022
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peppermint oil

Peppermint oil has an effect on menopausal symptoms, effect on happiness,effect on aging anxiety.

Other: Peppermint Oil
The researcher will add 2 drops of peppermint oil to 5 cc almond oil and give hand and arm massage to the participants for 30 minutes.

Other: Lemon Oil
The researcher will add 2 drops of lemon oil to 5 cc almond oil and give hand and arm massage to the participants for 30 minutes.

Experimental: Lemon oil

Lemon oil has an effect on menopausal symptoms, effect on happiness,effect on aging anxiety.

Other: Peppermint Oil
The researcher will add 2 drops of peppermint oil to 5 cc almond oil and give hand and arm massage to the participants for 30 minutes.

Other: Lemon Oil
The researcher will add 2 drops of lemon oil to 5 cc almond oil and give hand and arm massage to the participants for 30 minutes.

Experimental: Placebo group

Almond oil has an effect on menopausal symptoms, effect on happiness,effect on aging anxiety.

Other: plasebo
The researcher will 5 cc almond oil and give hand and arm massage to the participants for 30 minutes.

Outcome Measures

Primary Outcome Measures

  1. Menopause Symptoms Evaluation Scale [1 year]

    The original name of the scale is Menopause Rating Scale (MRS). The menopausal symptom rating scale (MSDS) was developed by Schneider et al. (2002) to measure the severity of menopausal symptoms. It was adapted into Turkish by Gürkan (2005). Menopause symptom assessment scale (MSDS) consists of 11 items. It is a Likert-type scale, and each item has options such as "None (0)", "Mild (1)", "Moderate (2)", "Severe (3)" and "Very Severe (4)". The total score of the scale is calculated by calculating the scores given for each item. A minimum of 0 points and a maximum of 44 points can be obtained from the scale. The increase in the total score obtained from the scale indicates the increase in the severity of the complaints. The Cronbach Alpha coefficient of the scale is 0.84.

Secondary Outcome Measures

  1. Oxford Happiness Scale Short Form [1 year]

    It was first developed by Argyle, Martin and Crossland (1989) in 29 items. Later, the short form was created by revising it by Hills and Argyle (2002). The Turkish adaptation of the scale was done by Doğan and Çötok (2011). The scale is a five-point Likert type (1-Strongly Disagree, 5-Completely Agree) self-report scale consisting of 7 items. The lowest score that can be obtained from the scale is 7 and the highest score is 35. Higher scores indicated higher happiness.

  2. Peace Scale [1 year]

    It is a one-dimensional, 8-item, five-point Liket type scale developed by Demirci and Ekşi (2017). As a result of the exploratory factor analysis performed for the construct validity of the scale, it was found that it had a one-dimensional structure consisting of 8 items with an eigenvalue of 3.226, explaining 40.328% of the total variance. The item factor load of the scale is between .55 and .71

  3. Aging Anxiety Scale [1 year]

    Originally developed by Lasher and Faulkender in 1993 to measure anxiety levels towards aging, consisting of 4 sub-dimensions and 20 questions: "Fear of the Elderly", "Fear of Loss Related to Aging", "Anxiety Related to Physical Appearance" and "Psychological Worries about Aging". "The Anxiety about Aging (AAS)" scale was adapted into Turkish for use in menopausal women. The scale is a 5-point Likert scale type: "Strongly Agree", "Agree", "Undecided", "Disagree" and "Strongly Disagree". After its adaptation to Turkish, the score that can be obtained from the scale consisting of 16 questions varies between 16-80. An increase in the score obtained from the scale indicates that individuals have high aging anxiety.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Experiencing at least 1 of the menopausal symptoms (self-report),

  • No respiratory disease such as asthma, bronchitis (self-report),

  • Not allergic to the oils to be used (self-report),

Exclusion Criteria:
  • Not experiencing menopausal complaints,

  • Those who do not want to participate in the research

Contacts and Locations

Locations

Site City State Country Postal Code
1 KTO Karatay University Konya Turkey 42000

Sponsors and Collaborators

  • KTO Karatay University

Investigators

  • Principal Investigator: HAFİZE DAĞ TÜZMEN, KTO Karatay University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
KTO Karatay University
ClinicalTrials.gov Identifier:
NCT05677698
Other Study ID Numbers:
  • Karatayhfz
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by KTO Karatay University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023