Objectives: This study is conducted to determine the effect of massage with aromatherapy on the severity of primary dysmenorrhea. Design: This study will be conducted on 72 female students residing in Mashhad University of Medical Sciences dormitory. Inclusion criteria: Iranian nationality; resident of Mashhad University of Medical Science dormitory; regular menstrual periods (22-35 days); The severity of pain in menstruation more than 60 mm (using visual pain scale and having an average severity of pain in the first three days of the menstrual period, over 2 control cycle, more than 60 mm). Exclusion criteria: a history of suffering from Obstetrics and Gynecology diseases; history of surgery on genitalia; Hormonal drugs consumption or having special food diet; mental and emotional diseases; BMI above 30; Heavy exercise; Endocrine disease. The samples will randomly (by blocking) divide into three groups, including the massage group with lavender oil, the massage group with paraffin oil and the massage group without any oil. Massage is performed from the first day of the menstruation for one day, daily for 15 minutes and routinely by the research unit itself. This study is not blinded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061134465N1
Registration date:2017-07-11, 1396/04/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-11, 1396/04/20
Registrant information
Name
Somayeh Alirezaei
Name of organization / entity
Mashhad University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 2276
Email address
somayea67@gmail.com
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage with aromatherapy (lavender oil) on primary dysmenorrhea
Public title
The effect of massage with lavender oil on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian nationality; resident of Mashhad University of Medical Science dormitory; regular menstrual periods (22-35 days); The severity of pain in menstruation is more than 60 mm (using visual pain scale and having an average severity of pain in the first three days of the menstrual period, over 2 control cycle which is more than 60 mm).
Exclusion criteria: a history of suffering from obstetrics and Gynecology disease; a history of surgery on genitalia; Hormonal drugs consumption or having special food diet; mental and emotional disease; BMI above 30; Heavy exercise; Endocrine disease.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Daneshgah Alley, Mashhad
City
Mashhad
Postal code
Approval date
2013-05-23, 1392/03/02
Ethics committee reference number
IR.mums.REC.13920302
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Intensity of menstrual pain
Timepoint
Every month for three consecutive months
Method of measurement
Visual scale of pain
Secondary outcomes
1
Description
Duration of menstrual pain
Timepoint
Every month for three consecutive months
Method of measurement
History
Intervention groups
1
Description
Intervention group 1: Massage with lavender oil, from the beginning of menstruation for one day, daily for 15 minutes, at the top of the symphisis pubis, periodically, conducted by the research unit itself.
Category
Treatment - Drugs
2
Description
Intervention group 2: Massage with paraffin oil, from the beginning of menstruation for one day, daily for 15 minutes, at the top of the symphisis pubis, periodically, is conducted by the research unit itself.
Category
Placebo
3
Description
Control group: Massage, from the beginning of the menstruation for one day, daily for 15 minutes, at the top of the symphisis pubis, periodically, is conducted by the research unit itself.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharestan 1
Full name of responsible person
Mahboubeh Ramezanzadeh
Street address
Medical Sciences Dormitory, Bahonar Alley, Vakil Abad Blvd, Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Baharestan 2
Full name of responsible person
Mahboubeh Ramezanzadeh
Street address
Medical Sciences Dormitory, Bahonar Alley, Vakil Abad Blvd, Mashhad
City
Mashhad
3
Recruitment center
Name of recruitment center
Baharestan 3
Full name of responsible person
Mahboubeh Ramezanzadeh
Street address
Medical Sciences Dormitory, Bahonar Alley, Vakil Abad Blvd, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, Daneshgah Ave, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Mahin Tafazoli
Position
MH holder of Midwifery
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, School of Nursing and Midwifery, Daneshgah Ave, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 8016
Fax
Email
tafazolim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Mahin Tafazoli
Position
MA holder of Midwifery
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, School of Nursing and Midwifery, Daneshgah Ave, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3859 8016
Fax
Email
tafazolim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Mahin Tafazoli
Position
MA holder of midwifery / Faculty member of Mashhad University of Medical Sciences, School of Nursing
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, School of Nursing and Midwifery, Daneshgah Ave, Mashhad
City
Mashhad
Postal code
Phone
Fax
Email
tafazolim@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)