Evaluation of the impact of dry cupping on primary dysmenorrhea among the students residing in Qazvin University of Medical Sciences dormitories: Random controlled clinical trial
Objective: Evaluation of the impact of dry cupping on primary dysmenorrhea among the students residing in Qazvin University of Medical Sciences dormitories.
Design: Random controlled clinical trial, phase II trial. The method of studying, the conditions of inclusion: single women in the range of 35-19 years old; living in students dormitories of Qazvin University of Medical Sciences; with regular menstrual cycles; moderate to severe primary dysmenorrhea; lack of any known chronic diseases like diabetes; the absence of symptoms like burning, itching and abnormal vaginal discharge; no hormonal problems; no history of pelvic disease, fibroids and tumors; no usage of certain medications and no stressful factors (separation of parents, death of first-degree relatives and so on) in the last six months.
Major excluding conditions: being under the age of 19 years and more than 35 years; irregular menstruation; menstrual without pain; mild primary dysmenorrhea; secondary dysmenorrhea; chronic disease; pelvic disease; being under the stressors in the past six months. Sample size: two of cupping therapy groups (test) and control group (75 patients in each group).
Interventions: hundred and fifty people entered the study and were randomly divided into two experimental and control groups. We use dry cupping for 3 menstrual periods at one time and then rotating within 3 days before the onset of menstruation (as prophylaxis) until end of menstruation in experimental group and no intervention in control group. During three consecutive cycle, severity of dysmenorrhea will be assessed with verbal multidimensional scoring system.
The main outcome variables: the severity and duration of primary dysmenorrhea, symptoms of dysmenorrhea.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120125320N1
Registration date:2017-02-18, 1395/11/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-18, 1395/11/30
Registrant information
Name
Maryam Taherpour
Name of organization / entity
Qazvin University of Medical Sciences, Qazvin, Iran
Country
Iran (Islamic Republic of)
Phone
+98 28 3323 7268
Email address
m.taherpour@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-12-19, 1395/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the impact of dry cupping on primary dysmenorrhea among the students residing in Qazvin University of Medical Sciences dormitories: Random controlled clinical trial
Public title
Evaluation of the impact of dry cupping on primary dysmenorrhea among the students residing in Qazvin University of Medical Sciences dormitories.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: single women in the range of 35-19 years old; living in students dormitories of Qazvin University of Medical Sciences; with regular menstrual cycles; moderate to severe primary dysmenorrhea; lack of any known chronic diseases like diabetes; the absence of symptoms like burning, itching and abnormal vaginal discharge; no hormonal problems; no history of pelvic disease, fibroids and tumors; no usage of certain medications and no stressful factors (separation of parents, death of first-degree relatives and so on) in the last six months.
Major excluding conditions: being under the age of 19 years and more than 35 years; irregular menstruation; menstrual without pain; mild primary dysmenorrhea; secondary dysmenorrhea; chronic disease; pelvic disease; being under the stressors in the past six months.
Age
From 19 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences , Shahid Bahonar Blvd , Qazvin
City
Qazvin
Postal code
Approval date
2015-11-08, 1394/08/17
Ethics committee reference number
IR.QUMS.REC.1394.193
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N 94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
severity and duration of primary dysmenorrhea
Timepoint
Before the intervention, one month, two months, three months after the intervention in case and control groups
Method of measurement
Verbal multidimensional scoring system
Secondary outcomes
1
Description
symptoms of dysmenorrhea
Timepoint
Before the intervention, one month, two months, three months after the intervention in case and control groups
Method of measurement
Verbal multidimensional scoring system
Intervention groups
1
Description
3 days before the onset of menstruation (as prophylaxis) until end of menstruation dry cupping for 3 menstrual periods at a time and rotations, use of the experimental group and the control group will not be any interference. In dry cupping, we are using from special cups to size 5 to 7 centimeters. Cotton soaked in alcohol that wrapped to a forceps Ignited made and in a rapid move take away inside the Cup and we're warm air inside the cup and Immediately putting up tops the lumbar sides spine and suprapubic for 10-15 minutes.
Category
Treatment - Other
2
Description
In the control group does not take place intervention