NCT05677698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 27, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
Last Updated

March 1, 2023

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

November 16, 2022

Last Update Submit

February 27, 2023

Conditions

Keywords

aromatherapymenopause

Outcome Measures

Primary Outcomes (1)

  • Menopause Symptoms Evaluation Scale

    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.

    1 year

Study Arms (3)

Peppermint oil

EXPERIMENTAL

Peppermint oil has an effect on menopausal symptoms

Other: peppermint oil

Lemon oil

EXPERIMENTAL

Lemon oil has an effect on menopausal symptoms.

Other: Lemon oil

almond oil

PLACEBO COMPARATOR

Almond oil has an effect on menopausal symptoms.

Other: Almond oil

Interventions

Lemon oil with massage

Lemon oil

peppermint oil with massage

Peppermint oil

Almond oil massage

almond oil

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen in menopause
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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),

You may not qualify if:

  • Not experiencing menopausal complaints,
  • Those who do not want to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42000, Turkey (Türkiye)

Location

Related Publications (24)

  • Farahani MA, Afsargharehbagh R, Marandi F, Moradi M, Hashemi SM, Moghadam MP, Balouchi A. Effect of aromatherapy on cancer complications: A systematic review. Complement Ther Med. 2019 Dec;47:102169. doi: 10.1016/j.ctim.2019.08.003. Epub 2019 Aug 5.

    PMID: 31779991BACKGROUND
  • Tanvisut R, Traisrisilp K, Tongsong T. Efficacy of aromatherapy for reducing pain during labor: a randomized controlled trial. Arch Gynecol Obstet. 2018 May;297(5):1145-1150. doi: 10.1007/s00404-018-4700-1. Epub 2018 Feb 3.

    PMID: 29397442BACKGROUND
  • Santoro N, Epperson CN, Mathews SB. Menopausal Symptoms and Their Management. Endocrinol Metab Clin North Am. 2015 Sep;44(3):497-515. doi: 10.1016/j.ecl.2015.05.001.

    PMID: 26316239BACKGROUND
  • Parry BL. Depressive history as a major predictor of postmenopausal depressive symptoms. Menopause. 2022 Jul 1;29(7):763-764. doi: 10.1097/GME.0000000000002027. No abstract available.

    PMID: 35728014BACKGROUND
  • Lee J, Han Y, Cho HH, Kim MR. Sleep Disorders and Menopause. J Menopausal Med. 2019 Aug;25(2):83-87. doi: 10.6118/jmm.19192. Epub 2019 Aug 5.

    PMID: 31497577BACKGROUND
  • Bansal R, Aggarwal N. Menopausal Hot Flashes: A Concise Review. J Midlife Health. 2019 Jan-Mar;10(1):6-13. doi: 10.4103/jmh.JMH_7_19.

    PMID: 31001050BACKGROUND
  • Cramer H, Peng W, Lauche R. Yoga for menopausal symptoms-A systematic review and meta-analysis. Maturitas. 2018 Mar;109:13-25. doi: 10.1016/j.maturitas.2017.12.005. Epub 2017 Dec 6.

    PMID: 29452777BACKGROUND
  • Johnson A, Roberts L, Elkins G. Complementary and Alternative Medicine for Menopause. J Evid Based Integr Med. 2019 Jan-Dec;24:2515690X19829380. doi: 10.1177/2515690X19829380.

    PMID: 30868921BACKGROUND
  • Kazemzadeh R, Nikjou R, Rostamnegad M, Norouzi H. Effect of lavender aromatherapy on menopause hot flushing: A crossover randomized clinical trial. J Chin Med Assoc. 2016 Sep;79(9):489-92. doi: 10.1016/j.jcma.2016.01.020. Epub 2016 Jul 4.

    PMID: 27388435BACKGROUND
  • Sanchez-Vidana DI, Ngai SP, He W, Chow JK, Lau BW, Tsang HW. The Effectiveness of Aromatherapy for Depressive Symptoms: A Systematic Review. Evid Based Complement Alternat Med. 2017;2017:5869315. doi: 10.1155/2017/5869315. Epub 2017 Jan 4.

    PMID: 28133489BACKGROUND
  • Gurler M, Kizilirmak A, Baser M. The Effect of Aromatherapy on Sleep and Quality of Life in Menopausal Women with Sleeping Problems: A Non-Randomized, Placebo-Controlled Trial. Complement Med Res. 2020;27(6):421-430. doi: 10.1159/000507751. Epub 2020 Jun 9.

    PMID: 32516765BACKGROUND
  • El Khoudary SR, Greendale G, Crawford SL, Avis NE, Brooks MM, Thurston RC, Karvonen-Gutierrez C, Waetjen LE, Matthews K. The menopause transition and women's health at midlife: a progress report from the Study of Women's Health Across the Nation (SWAN). Menopause. 2019 Oct;26(10):1213-1227. doi: 10.1097/GME.0000000000001424.

    PMID: 31568098BACKGROUND
  • Taşkın L, editör. Doğum ve kadın sağlığı hemşireliği. Genişletilmiş XIII. Baskı. Ankara: Akadmisyen Tıp Kitabevi; 2019. p. 671-687

    BACKGROUND
  • Gözüyeşil E, Başer M. 2016.'' Menopozal dönemde yaşanan vazomotor yakınmaların günlük yaşam aktiviteleri üzerine etkisi'', Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 19(4):1-8.

    BACKGROUND
  • Türkiye İstatistik Kurumu. İstatistiklerle kadın, 2019. Türkiye İstatistik Kurumu Haber Bülteni. Sayı: 33732 Yayın Tarihi: 06.03.2020 1-5.

    BACKGROUND
  • Es-Haghee S, Shabani F, Hawkins J, Zareian MA, Nejatbakhsh F, Qaraaty M, Tabarrai M. The Effects of Aromatherapy on Premenstrual Syndrome Symptoms: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Evid Based Complement Alternat Med. 2020 Dec 21;2020:6667078. doi: 10.1155/2020/6667078. eCollection 2020.

    PMID: 33414837BACKGROUND
  • Taavoni S, Darsareh F, Joolaee S, Haghani H. The effect of aromatherapy massage on the psychological symptoms of postmenopausal Iranian women. Complement Ther Med. 2013 Jun;21(3):158-63. doi: 10.1016/j.ctim.2013.03.007. Epub 2013 Apr 16.

    PMID: 23642946BACKGROUND
  • Nikjou R, Kazemzadeh R, Asadzadeh F, Fathi R, Mostafazadeh F. The Effect of Lavender Aromatherapy on the Symptoms of Menopause. J Natl Med Assoc. 2018 Jun;110(3):265-269. doi: 10.1016/j.jnma.2017.06.010. Epub 2017 Aug 18.

    PMID: 29778129BACKGROUND
  • Hur MH, Yang YS, Lee MS. Aromatherapy massage affects menopausal symptoms in korean climacteric women: a pilot-controlled clinical trial. Evid Based Complement Alternat Med. 2008 Sep;5(3):325-8. doi: 10.1093/ecam/nem027.

    PMID: 18830459BACKGROUND
  • Abbaspoor Z, Siahposh A, Javadifar N, Faal Siahkal S, Mohaghegh Z, Sharifipour F. The Effect of Citrus Aurantium Aroma on the Sleep Quality in Postmenopausal Women: A Randomized Controlled Trial. Int J Community Based Nurs Midwifery. 2022 Apr;10(2):86-95. doi: 10.30476/IJCBNM.2021.90322.1693.

    PMID: 35372632BACKGROUND
  • Darsareh F, Taavoni S, Joolaee S, Haghani H. Effect of aromatherapy massage on menopausal symptoms: a randomized placebo-controlled clinical trial. Menopause. 2012 Sep;19(9):995-9. doi: 10.1097/gme.0b013e318248ea16.

    PMID: 22549173BACKGROUND
  • Tsai J, Chung YC, Chen FP, Yeh ML. [Effect of Aromatherapy on Menopausal Symptoms, Heart Rate Variability, and Sleep Quality in Women]. Hu Li Za Zhi. 2020 Feb;67(1):44-54. doi: 10.6224/JN.202002_67(1).07. Chinese.

    PMID: 31960396BACKGROUND
  • Dos Reis Lucena L, Dos Santos-Junior JG, Tufik S, Hachul H. Lavender essential oil on postmenopausal women with insomnia: Double-blind randomized trial. Complement Ther Med. 2021 Jun;59:102726. doi: 10.1016/j.ctim.2021.102726. Epub 2021 Apr 24.

    PMID: 33905827BACKGROUND
  • Doner SI, Dag Tuzmen H, Duran B, Sunar F. The effect of aromatherapy massage with lemon and peppermint essential oil on menopausal symptoms: A double-blinded, randomized placebo controlled clinical trial. Explore (NY). 2024 May-Jun;20(3):313-318. doi: 10.1016/j.explore.2023.09.001. Epub 2023 Sep 13.

Related Links

MeSH Terms

Interventions

lemon oilpeppermint oilalmond oil

Study Officials

  • HAFİZE DAĞ TÜZMEN

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2022

First Posted

January 10, 2023

Study Start

December 27, 2022

Primary Completion

January 30, 2023

Study Completion

February 27, 2023

Last Updated

March 1, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations