NCT06289764

Brief Summary

Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being. Premenstrual syndrome (PMS) is a health problem characterized by the periodic occurrence of physical, cognitive, emotional and behavioral symptoms during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is reported that approximately 80-95% of women complain of PMS complaints. Although the use of aromatherapy in womens health is widespread, there is no study comparing bergamot and grapefruit essential oils. The aim of this study was to determine the effect of aromatherapy with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms.

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 Feb 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

February 7, 2024

Last Update Submit

October 9, 2024

Conditions

Keywords

AromatherapyPremenstrual syndromeMenstrual symptom

Outcome Measures

Primary Outcomes (1)

  • Premenstrual syndrome scale (PMS)

    It is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms. A minimum of 44 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 PMS symptoms increases. In the PMS scale, PMS is considered to be "present" if it exceeds 50% (110) of the total scale score (220).

    Baseline and three months later

Secondary Outcomes (1)

  • Menstrual Symptom Scale

    Baseline and three months later

Study Arms (3)

Sweet almond oil

PLACEBO COMPARATOR

Premenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm.

Other: Sweet almond oil

Bergamot essential oil

EXPERIMENTAL

Premenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm

Other: Bergamot Essential Oil

Grapefruit essential oil

EXPERIMENTAL

Premenstrual symptom scale will be applied to the participants who volunteered to participate in the study. Aromatherapy will be applied to people with a premenstrual symptom score exceeding 110. 3 groups will be formed from people with pms symptoms. 1st group will receive Bergamot essential oil, 2nd group will receive Grapefruit essential oil, 3rd group (placebo group) will receive sweet almond oil. Selected women will be allowed to smell 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. The aromatic oil will be put 3 drops on a cotton ball and the participants will smell it. Participants will be allowed to inhale the scent for 30 minutes in the fowler position at a distance of 15 cm

Other: Grapefruit Essential Oil

Interventions

Selected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles.

Bergamot essential oil

Selected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles.

Grapefruit essential oil

Selected women will be smelled 3 times a day, at the same time every day, for 4 days, within 7 days before menstruation. Application will be repeated for 3 cycles

Sweet almond oil

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be between the ages of 18-35
  • Experiencing at least 5 of the pms complaints (self-report)
  • Not having respiratory diseases such as asthma and bronchitis (self-report)
  • No pregnancy or suspected pregnancy (self-report)
  • Not being allergic to any substance (self-report)
  • Not having a systemic disease such as diabetes, hypertension (self-report)

You may not qualify if:

  • Under 18, over 35 years of age Not experiencing pms complaints Finding anosmia Presence of respiratory system diseases Allergic symptoms to aromatherapy Being pregnantHaving a chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol Unıversty

Ankara, Altındağ, 06000, Turkey (Türkiye)

Location

Related Publications (1)

  • Ozer E, Doner SI, Dag Tuzmen H. The effect of aromatherapy intervention with Bergamot and Grapefruit essential oils on premenstrual syndrome and menstrual symptoms: a randomized controlled trial. BMC Complement Med Ther. 2025 May 1;25(1):162. doi: 10.1186/s12906-025-04857-3.

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

almond oil

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Esra Ö ÖZER, Assist Prof.

    Ankara Medipol Unıversty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

February 7, 2024

First Posted

March 4, 2024

Study Start

February 1, 2024

Primary Completion

April 20, 2024

Study Completion

June 24, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

It will be planned after the study is completed.

Locations