NCT05599594

Brief Summary

Aromatherapy is the science of using high concentrated essential oils or essences with distilled high concentration of plants to take advantage of therapeutic properties '' . Essential oils or essences are obtained from various parts of plants (root, leaf, flower, shell, fruit) and therapeutically used for physical and psychological favors. The aromatherapine is a noninvasive process and the convenience of use allows the widespread use of aromatherapy. Aromatic oils can be applied in four basic ways. These are topical (tap, compressed or bath), internal (mouthwash, vaginal or anal wick), mouth (with capsules or honey, alcohol or diluent) and inhalation (inhalation directly or indirectly, steam or vapor ) is the way . Volatile oils that can be applied in various means can reach the neocortex part of the brain directly with the links to the hypothalamus from the limbic system. As a result of the impact of aromatic oils on the central nervous system, relief, sedation or stimulating effects are formed and the energy blockage in the body is broken, due to the information stream reaching the brain with the warning of the central nervous system and the resulting energy is exposed. The improvement process is supported by its exposed energy stream in a balanced way of the relevant organs, and the state of physical and spiritual goodness is emerged. Aromatherapy is also used in the field of women's health as well as many health areas.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 26, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 26, 2023

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

April 26, 2022

Last Update Submit

October 25, 2023

Conditions

Keywords

AromatherapyPremenstrual symptomQuality of life

Outcome Measures

Primary Outcomes (2)

  • Personal Information Form

    A questionnaire with 12 questions was created by the researchers. The filling time of the participants is 5-6 minutes.

    1 year

  • Premenstrual Syndrome Scale

    Participants in the study will be asked to fill in this scale in the pre-test. Women with premenstrual syndrome will be included in the study.The application of the premenstrual syndrome scale is made by evaluating the person retrospectively, taking into account the "being in the period one week before the period". The total score is obtained from the sum of the scores from all sub-dimensions. 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 an increase in the intensity of the symptoms. If the total scale score (220) exceeds 50% (110) in the PMS scale, PMS is considered as "present".

    1 year

Secondary Outcomes (2)

  • Scale for Coping With Premenstrual Symptoms

    1 year

  • SF-36 Quality of Life Scale

    1 year

Study Arms (2)

Neroli oil

EXPERIMENTAL

Neroli oil improves the quality of life by reducing premenstrual symptoms with relaxing and calming effect.

Other: Aromatherapy

Lemongrass oil

EXPERIMENTAL

Lemongrass oil improves the quality of life by reducing premenstrual symptoms with relaxing and calming effect.

Other: Aromatherapy

Interventions

6 drops of aromatic oils used by the researcher will be dripped by the aromatic oils to take the fragrance by inhalation for 30 minutes.

Lemongrass oilNeroli oil

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenstrual is at least 5 of the complaints living (self-notice),
  • Non-respiratory disease such as asthma, bronchitis (self-notice),
  • Not allergic to fat to be used (self-notice),
  • Pregnancy or pregnancy doubt (self-notice),
  • Diabetes, hypertension without a systemic discomfort (self-notice)

You may not qualify if:

  • Premenstrual has not experienced complaints,
  • Using cigarettes or alcohol,
  • With chronic discomfort (respiratory diseases),
  • Pregnancy suspected or conceived,
  • With a systemic discomfort such as diabetes, hypertension,
  • Individuals who do not want to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Füsun SUNAR, Associate Professor

    Kto Karatay Üniversitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafize DAĞ TÜZMEN, Phd, Student Nursing

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In the study, the evaluation and statistical analysis will be blinded. Statistical analyzes will be carried out by a faculty member other than researchers. A non-aware of the experiment and control groups will be aware of the assessment of initiatives. Data entries will be entered with "A", "B" and "C" code without the test or control group specified. Writing the analysis and research report of the data will be carried out to be coded as "A", "B" and "C" group. After the statistical analysis is made and the research report is written, the encoders for the experiment and the control group will be explained by the encoder by the encoder. The data collection tool described below before the venture and the control group will be applied below
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 3 groups will be formed from the students identified with the symptoms of premenstrual syndrome. 1.Gruba Neroli, 2.Gruba Lemongrass, to Group 3 (Placebo Group) will be given water vapor and the states of premenstrual syndrome among the groups and the status of premenstrual symptoms will be evaluated. Pre-process pre-test will be applied to all groups. After each application will be tested again. The final test will be applied to each participant's first day of menstruation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

October 31, 2022

Study Start

December 15, 2023

Primary Completion

January 30, 2024

Study Completion

July 30, 2024

Last Updated

October 26, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations