The purpose of this study was the effect of aromatherapy on Symptoms of Dysmenorrhea and amount of bleeding of menstrual cycles in female students with primary dysmenorrheain. The study was a randomized trial. The subjects were 96 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: (1) an experimental group who received aromatherapy with lavender (2) a placebo group .Aromatherapy was applied in the form inhalation with using five drops of lavender in sesame oil. The 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 symptoms 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:IRCT201105086412N1
Registration date:2012-08-25, 1391/06/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-25, 1391/06/04
Registrant information
Name
Ziba Raisi Dehkordi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
zibard@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender aromatherapy on primary dysmenorrhea in students of Tehran University of Medical Sciences dormitories
Public title
The effect of lavender aromatherapy on primary dysmenorrhea in students of Tehran University of Medical Sciences dormitories
Purpose
Treatment
Inclusion/Exclusion criteria
The selection criteria were: 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.The exclusion criterion was allergy to lavender.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz BLD, Ghods street, Central building of Tehran University of Medical Sciences
City
Tehran
Postal code
88987381
Approval date
2010-12-22, 1389/10/01
Ethics committee reference number
90/د/130/521
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
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
Primary dysmenorrhoea
Timepoint
Two months before the intervention and Two months after the intervention
Method of measurement
Multidimensional questionnaires grading scales and VAS scale
Secondary outcomes
1
Description
vomiting, nausea,,Tierdness/dizziness, Diarrhea, Mood change, Faint and Hot flushing and amount bleeding
Timepoint
2 month befor intervention and 2 month after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
experimental group, Aromatherapy was applied in the form inhalation with using five drops of lavender in sesame oil. for 3 minutes every 6 hours, for two period, one day before the start of menstruation and continuing until the third day of menstruation.
Category
Treatment - Drugs
2
Description
placebo group, Aromatherapy was applied in the form inhalation with using five drops of lavender in sesame oil. for 3 minutes every 6 hours, for two period, one day before the start of menstruation and continuing until the third day of menstruation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls Dormitory
Full name of responsible person
Ziba Raisi Dehkordi
Street address
Keshavarz BLD, Ghods street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Tehran University of Medical Sciences
Full name of responsible person
Abbas Hoshmand Behabadi
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Tehran 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
Tehran University of Medical Scinces
Full name of responsible person
Ziba Raisi Dehkordi
Position
Tehran
Other areas of specialty/work
Street address
Tehran
City
Nosrat ST, Tohid Sq, Faculty of Nursing and Midwifery
Postal code
00989123906609
Phone
+98 21 6692 7171
Fax
Email
zibard@skums,ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Scinces
Full name of responsible person
Ziba Raisi Dehkordi
Position
post graduate student
Other areas of specialty/work
Street address
Nosrat ST. Tohid SQ, Faculty of Nursing and Midwifery
City
TEhran
Postal code
00989123906609
Phone
+98 21 6692 7171
Fax
Email
zibard@skums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba Raisi Dehkordi
Position
post graduate student
Other areas of specialty/work
Street address
Nosrat ST.Tohid SQ, Faculty of Nursing and Midwifery
City
Tehran
Postal code
00989123906609
Phone
+98 21 6692 7171
Fax
Email
zibard@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)