Determining the effect of lavender essential oil on the severity of Premenstrual syndromesymptoms.
Design
"The intervention group will receive lavender essential oil inhalation for 11 days (7 days pre-menstrual and first 4 days of menstruation) over two months, with PMS symptoms recorded on a data form. The control group will receive almond oil inhalation using the same protocol."
Settings and conduct
Data will be collected using a demographic characteristics questionnaire, a provisional premenstrual syndrome (PMS) screening questionnaire, a daily symptom record form (PSST questionnaire), and the Beck Depression Inventory. Eligible participants will first complete the initial PMS screening questionnaire. Those who report at least 5 symptoms from the daily symptom record form during the week before menstruation through the fourth day of menstruation will be included in the study. These eligible participants will then complete the daily symptom record form for two consecutive months.
After this two-month baseline period, participants will be randomly allocated to either the intervention or control group. The intervention group will receive aromatherapy via inhalation of 3 drops of lavender essential oil, twice daily, for 11 days (from 7 days before menstruation through the 4th day of menstruation). The control group will receive almond oil inhalation using the same protocol. The data analyst will remain blinded to group allocation throughout the study.
Participants/Inclusion and exclusion criteria
having regular menstruation (21-35 days), not taking hormonal and vitamin drugs.
Intervention groups
Aromatherapy will be performed twice a day with 3 drops of lavender essential oil from 7 days before menstruation to the fourth day of menstruation (14 days) by the participants themselves.
Main outcome variables
Severity of premenstrual syndrome symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230220057463N1
Registration date:2026-08-04, 1405/05/13
Registration timing:registered_while_recruiting
Last update:2026-08-04, 1405/05/13
Update count:0
Registration date
2026-08-04, 1405/05/13
Registrant information
Name
Arezoo Pirak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 689 9447
Email address
pirak.arezoo@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-02, 1405/05/11
Expected recruitment end date
2027-03-02, 1405/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Lavandula Essence on the severity of premenstrual syndrome (PMS) in students.
Public title
The effect of Lavandula Essence on the severity of premenstrual syndrome (PMS) symptoms in students of Iranshahr University of Medical Sciences 1401
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having regular menstruation (21-35 days),
not taking antidepressants in the last few months, not taking hormonal and vitamin drugs
Exclusion criteria:
Diagnosis of depression (with standard Beck questionnaire),
the occurrence of events such as the death of relatives, divorce and other unfortunate events,
occurrence of menstrual disorders during the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this way, according to the sample size, 80 cards were prepared, 40 cards with the letter A on it and 40 cards with the letter B written on it and placed in a container. All eligible students choose one of the cards, card A will be the intervention group and card B will be the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The groups are provided to the analyzer as A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iranshahr University of Medical Sciences
Street address
Baluch Blvd.- Roozbeh Psychiatric Hospital- Deputy Research and Technology
City
Iranshahr
Province
Sistan-va-Balouchestan
Postal code
9914786138
Approval date
2022-05-23, 1401/03/02
Ethics committee reference number
IR.IRSHUMS.REC.1401.003
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome symptoms
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of premenstrual syndrome symptoms
Timepoint
7 days before menstruation and the first 4 days of menstruation
Method of measurement
Premenstrual Symptoms Questionnaire (PSST)
Secondary outcomes
empty
Intervention groups
1
Description
"Aromatherapy with lavender essential oil will be performed by the participants themselves, twice a day, with 3 drops of lavender essential oil, from 7 days before menstruation until the fourth day of menstruation (11 days total). In this study, 3 drops of lavender essential oil will be added to 200 mL of hot water; then, the participant's head will be covered with a towel while seated, and she will inhale the steam. This intervention will be carried out for 2 months.
Category
Rehabilitation
2
Description
Control group: In the control group, almond oil will be administered by the participants themselves twice daily, with 3 drops, starting 7 days before menstruation and continuing until the fourth day of menstruation (total of 11 days). In this study, 3 drops of almond oil will be added to 200 mL of hot water; then, the participant's head will be covered with a towel while seated, and she will inhale the steam. This placebo intervention will be carried out for 2 months in the control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranshahr University of Medical Sciences
Full name of responsible person
Arezoo pirak
Street address
Shahid Fath Moradi Highway - Faculty of Medicine
City
Iranshahar
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Fax
+98 54 3721 3397
Email
pirak.arezoo@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
dr.farzaneh faraji
Street address
Baluch Blvd.- Roozbeh Psychiatric Hospital- Deputy Research and Technology
City
Iranshahar
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Fax
+98 54 3721 3397
Email
pirak.arezoo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranshahr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Arezoo pirak
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahid Fath Moradi Highway - Faculty of Medicine
City
Iranshahar
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Email
pirak.arezoo@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Arezoo pirak
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahid Fath Moradi Highway - Faculty of Medicine
City
Iranshahar
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Email
pirak.arezoo@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iranshahr University of Medical Sciences
Full name of responsible person
Arezoo pirak
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahid Fath Moradi Highway - Faculty of Medicine
City
Iranshahar
Province
Sistan-va-Balouchestan
Postal code
9914786138
Phone
+98 54 3721 0483
Email
pirak.arezoo@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Primary outcomes of the study: premenstrual syndrome (PMS) symptoms"
When the data will become available and for how long
After the results are published"
To whom data/document is available
Researchers worldwide
Under which criteria data/document could be used
If requested"
From where data/document is obtainable
the corresponding author
What processes are involved for a request to access data/document
Applicants must submit a written request to the corresponding author after publication of the results. The request should include the applicant's name, institutional affiliation, purpose of access, and the specific data required. After approval by the research team, de-identified (coded) data will be sent via email. The entire process, from receipt of the request to data submission, is expected to take approximately 2 to 4 weeks.