The purpose of this study was to investigate the effect of aromatherapy on Dysmenorrhea in female students with primary dysmenorrhea. The study was a randomized trial. The subjects were 100 female students who that they suffered from level 2 and 3 dysmenorrhea and had no systemic or reproductive diseases, and who did not use contraceptive drugs. Subjects were randomized into Two groups: Experimental group who received aromatherapy with lavender, placebo group received the same treatment but with sesame oil only. Each participant was monitored during 4 menstrual periods. During the first and second periods participants documented their own Severity of dysmenorrhea without any intervention applied. During the third and forth period, one of the two applications (placebo or aromatherapy) was applied. Following each application, the severity of dysmenorrhea and dysmenorrhea were measured. After the intervention, the levels of dysmenorrhea were measured for each group on the first, second and Third days of the third and forth menstruation period. .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070616255N2
Registration date:2014-11-24, 1393/09/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-24, 1393/09/03
Registrant information
Name
Roya Nikjou
Name of organization / entity
Ardabil University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 45 1771 7137
Email address
roya.nikjou@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
ََArdebil University of Medical Sciences
Expected recruitment start date
2014-09-20, 1393/06/29
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on dysmenorrhea
Public title
The effect of lavender aromatherapy on dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : The risk of dysmenorrhea according to menstrual history; History from level 2 and 3 dysmenorrhea no systemic disease or disease of the genital organs; No use of contraceptives; Being single; Had a normal sense of smell; None allergies to fragrances; Regular menstrual cycles; Had not been using analgesics to overcome dysmenorrhea, Exclusion criteria: Was allergy to lavender.
Age
From 45 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardebil University of Medical Sciences
Street address
University Street
City
Ardebil
Postal code
56189-85991
Approval date
2014-04-18, 1393/01/29
Ethics committee reference number
Arums.ERc.93.49
2
Ethics committee
Name of ethics committee
Ardebil University of Medical Sciences
Street address
University Street
City
ardebil
Postal code
56157-51147
Approval date
2013-06-15, 1392/03/25
Ethics committee reference number
Arums.ERc.93.49
Health conditions studied
1
Description of health condition studied
Dysmenorrhea
ICD-10 code
n94/4
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Dysmenorrhoea
Timepoint
One months before the intervention and Two months after the intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: Aromatherapy was applied in the form inhalation with using five drops of lavender for 3 minutes every 6 hours, for two period, one day before the start of mensturation and continuing until the third day of mensturation.
Category
Treatment - Drugs
2
Description
Control group: Aromatherapy was applied in the form inhalation with using five drops of Sesame for 3 minutes every 6 hours, for two period, one day before the start of mensturation and continuing until the third day of mensturation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls Dormitory
Full name of responsible person
Roya Nikjou
Street address
Faculty of Nursing and Midwifery
City
Ardebil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Ardebil University of Medical Sciences
Full name of responsible person
Hadi Piry dogaheh
Street address
University Street
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Ardebil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Roya.Nikjou
Position
Master of Midwifery
Other areas of specialty/work
Street address
Shohada Street, Faculty Nursing and Midwifery
City
Ardebil
Postal code
56157-51147
Phone
+98 45 1772 6085
Fax
+98 45 1772 8004
Email
roya.nikjou@arums.ac.ir; nikjoukhiavloo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Roya Nikjou
Position
MSc of Midwifery
Other areas of specialty/work
Street address
Shohada street, Faculty Nursing and Midwifery
City
Ardebil
Postal code
56157-51147
Phone
+98 45 1772 6085
Fax
+98 45 1772 8004
Email
roya.nikjou@arums.ac.ir; nikjookhiavloo@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Roya Nikjou
Position
MSc of Midwifery
Other areas of specialty/work
Street address
ُShohadaُُ street Faculty Nursing and Midwifery
City
Ardebil
Postal code
56157-51147
Phone
+98 45 1772 6085
Fax
Email
roya.nikjou@arums.ac.ir; nikookhiavloo@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)