This study will be conducted with the aim of determining the effect of auriculotherapy on premenstrual syndrome in female students residing in dormitories of Mashhad University of Medical Sciences. This study is a three-group clinical trial. The subjects will be assigned randomly to three groups of 60; that is, a seed and a non-seed auriculotherapy group and a negative control group. From six days before to four days after the onset of menstruation, pressure must be applied on the seed four times a day for one minute each time. The premenstrual syndrome symptoms severity questionnaire will be completed in both groups two months before and two months after the intervention. inclusion criteria: being aged between 20 and 40 years; regular menstrual period(with equal intervals of 21 to 35 days); presence of at least five symptoms of premenstrual syndrome in the last two months; and normal body mass. exclusion criteria: having a history of physical and psychological diseases and depression; having a history of consuming antidepressants, sedatives, or hormonal drugs; presence of any mass, inflammation, infection, or injury in the outer ear in the auriculotherapy group; unwillingness to continue the cooperation, or death; and failure to fill out the daily symptoms table correctly and completely(as described).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050921934N3
Registration date:2017-08-21, 1396/05/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
Sedigheh Sheidaei
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3774 7244
Email address
sheidaeis931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-05-09, 1396/02/19
Expected recruitment end date
2017-12-10, 1396/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ear acupressure on premenstrual syndrome
Public title
The effect of ear acupressure on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being aged between 20 and 40 years; regular menstrual period(with equal intervals of 21 to 35 days); presence of at least five symptoms of premenstrual syndrome in the last two months; and normal body mass.
Exclusion criteria: having a history of physical and psychological diseases and depression; having a history of consuming antidepressants, sedatives, or hormonal drugs; presence of any mass, inflammation, infection, or injury in the outer ear in the auriculotherapy group; unwillingness to continue the cooperation, or death; and failure to fill out the daily symptoms table correctly and completely(as described).
Age
From 20 years old to 39 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Deputy of Research and Technology, After Hoveyze Cinema, Daneshgah street, Mashhad University of Medical Science, Mashhad
City
Mashhad
Postal code
Approval date
2017-05-07, 1396/02/17
Ethics committee reference number
IR.MUMS.REC.1396.24
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
premenstrual tention syndrome
Primary outcomes
1
Description
premenstrual syndrome(edema, low back pain,low abdominal pain,mastalgia,..)
Timepoint
2 months before treatment and 2 months after treatment
Method of measurement
DSM-IV questionnair
Secondary outcomes
1
Description
Depression
Timepoint
2 months before treatment and 2 months after treatment
Method of measurement
Beck questionairs
Intervention groups
1
Description
Intervention Groups: trained 6 days before to 4 days after the onset of menstruation on seeds in the liver, the kidneys, the base of the brain, gastric, ovarian and uterine pressure 4 times a day, each time one minute
Category
Treatment - Other
2
Description
The intervention group without SID: trained 6 days before to 4 days after the onset of menstruation-free adhesives Sayed without pressure on the liver, the kidneys, the base of the brain, gastric, ovarian and uterine install.
Category
Other
3
Description
Control: no intervention is not performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Girls dormitories of Mashhad University of Medical Sciences
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Science
Full name of responsible person
Dr Saieed Eslami
Street address
Deputy of Research and Technology, After Hoveyze Cinema, Daneshgah street, Mashhad University of Medical Science, 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 Science
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
Full name of responsible person
Farzane Jafar Nejad
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ibn Sina Street، Doctoora intersection
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
JaafarnejadF@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzane Jafar Nejad
Position
Master of Midwifery
Other areas of specialty/work
Street address
Ibn Sina Street، Doctoora intersection
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
JaafarnejadF@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Sedigheh Sheidaei
Position
Graduate Student Midwives
Other areas of specialty/work
Street address
Ibn Sina Street, Doctora intersection
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
sheidaeis931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)