Comparison of the Effect of Massage Therapy With Rose Aroma and Without it on Primary Dysmenorrhea in girls who settle at Tehran University of Medical Sciences Dormitories in 1392
The purpose of this study is to investigate the effect of aromatherapy massage on primary dysmenorrhea. 75 girls aged 18–35 years old with primary dysmenorrhea whom severity of pain is greater than 5 on a 10 point visual analogue scale, will be randomly assigned in to the intervention. All girls settle at Tehran University of Medical Sciences dormitories. Participants with myoma, fibrocystadenoma or polycystic ovarian will exclude form the study. The pre-intervention data of visual analogue scale of each group will be collected from the first day of the latest menstrual cycle. Participants will be divided in 3 groups (each contains 25 participants). Group 1 will apply massage with essential oil (Rosa damascene 3% diluted in almond oil), group 2 will apply massage with unscented almond oil, group 3 will apply just massage. After intervention data will be collected and analyzed statistically. This intervention will continue in the second menstrual cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012081310182N2
Registration date:2013-08-24, 1392/06/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-24, 1392/06/02
Registrant information
Name
Homa Sadeghi Avval Shahr
Name of organization / entity
Tehran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
ho-sadeghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Massage Therapy With Rose Aroma and Without it on Primary Dysmenorrhea in girls who settle at Tehran University of Medical Sciences Dormitories in 1392
Public title
Comparison of the Effect of Massage Therapy with and without Aroma on Primary Dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Regular Menstruation; Age 18-35; Menarch age 11-17; Single status; Have no Choronic diseases and Psychological disorders and Anatomic Abnormalities ; Have no skin problem; Have no Abnormal Uterine Bleeding; Not use of any contraceptives; No use of any other complementary and alternative therapies; Menstrual pain severity greater than 5 pionts.Exclusion criteria: Unwillingness to cooperate; Abnormal Uterine Bleeding during study; Patients with myoma, fibrocystadenoma or polycystic ovarian; Allergies to essential oils.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Central Building of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard, Tehran
City
Tehran
Postal code
Approval date
2013-06-17, 1392/03/27
Ethics committee reference number
473/130/د/92
Health conditions studied
1
Description of health condition studied
primary Dysmenorrhea
ICD-10 code
N94
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
primary Dysmenorrhea
Timepoint
before and after of intervention in first and second cycle
Method of measurement
VAS
Secondary outcomes
1
Description
side effect
Timepoint
after intervention
Method of measurement
VAS
Intervention groups
1
Description
First group: Essential oil (Rosa damascene 3% diluted in almond oil). The participants will massage their abdomens with 5 drops essential oil, with clockwise circular movement, on the region above the pubic symphysis. Once a day, on the first day of the first and second cycles of menstruation.
Category
Treatment - Other
2
Description
second group: The participants will massage their abdomens with 5 drops of almond oil, with clockwise circular movement, on the region above the pubic symphysis. Once a day, on the first day of the first and second cycles of menstruation.
Category
Treatment - Other
3
Description
Third group: The participants will massage their abdomens with clockwise circular movement, on the region above the pubic symphysis. Once a day, on the first day of the first and second cycles of menstruation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, dormitories
Full name of responsible person
Ali Mohammadi fiez abadi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Vesal Dormitory
Full name of responsible person
Ali Mohammadi Feizabadi
Street address
Number 4, Shahed Street, Vesal Street, keshavarz Blvd
City
Tehran
3
Recruitment center
Name of recruitment center
First, Golestan Dormitory
Full name of responsible person
Ali Mohammadi Feizabadi
Street address
North Kargar St, Front St. 16, Integrated Medical Sciences Tehran dormitory
City
Tehran
4
Recruitment center
Name of recruitment center
third, Golestan Dormitory
Full name of responsible person
Ali Mohammadi Feizabadi
Street address
North Kargar St, Front St. 16, Integrated Medical Sciences Tehran dormitory
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fotoohi Akbar
Street address
Central Building of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Sciences
Full name of responsible person
Homa Sadeghi Avval Shahr
Position
Faculty of Nursing & Midwifery of Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, tohid square
City
Tehran
Postal code
Phone
+98 912 613 8085
Fax
Email
Ho-sadeghi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Homa Sadeghi Avval Shahr
Position
Mcs
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery of Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 912 613 8085
Fax
Email
Ho-sadeghi@tums.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
Mina Sadat Saadat Hosieni
Position
MCs Student
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery of Tehran University of Medical sciences
City
Tehran
Postal code
1418743453
Phone
+216 6426300
Fax
Email
m_saadath@razi.tums.ac.irmina_saadat_h@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)