The aim of this randomized controlled trial is to compare the effectiveness of acupressure at the sanyinjiao point (sp6) and Ibuprofen on primary dysmenorrhea (spasmodic, congestive). It will be conducted on 72 single female students of 18-22 years old with medium to severe primary dysmenorrhea (two 18-person groups with spasmodic dysmenorrhea and two 18-person groups with congestive dysmenorrhea). Initial questionnaire includes demographic characteristics, history of menstrual, gynecological diseases, general health, psychiatric disorders and 10-cm visual analogue scale for pain severity. Subjects will complete menstrual symptom questionnaire (MSQ) to distinguish type of primary dysmenorrhea. In the acupressure groups, an expert will instruct participants how to use the technique and the ibuprofen groups will be explained about the consumption manner. The subjects will be asked to complete the SSS questionnaire and the length of daily rest from two days before to two days after menstruation for three continuous menstrual cycles (once before and twice after intervention).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901253706N1
Registration date:2010-09-21, 1389/06/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-09-21, 1389/06/30
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2010-10-23, 1389/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of acupressure at the sanyinjiao point (sp6) and Iboprofen on primary dysmenorrhea (spasmodic, congestive)
Public title
The comparison of the effectiveness of acupressure and Iboprofen on primary dysmenorrheal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Single, age 18-22, Having regular menstrual cycle (mensturation length 3-8 days and length of menstrual cycle 21-35 days) and suffering from dysmenorrhea in previous two years, pain score more than 5 according to visual analogue scale (medium to severe dysmenorrhea), lack of known pelvic disease and known physical and mental diseases, Non consumption of oral contraceptive pills, Lack of pain throughout menstrual cycle or throughout menstrual bleeding, Lack of allergy to NSAIDs, lack of ulcer and inflammatory or skin disease around sp6 point. Exclusion Criteria: Occurrence of Pelvic disease, pelvic and abdomen operations, high emotional stress (parents' divorce, relative death, etc).
Age
From 18 years old to 22 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
Not used
Assignment
Parallel
Other design features
To prevent contamination (teaching the technique by subjects in the accupressure groups to the other subjcts), cluster random allocation will be used. If the number of the eligible persons in any group is more than 18, simple randomization will be used to select the subjects.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences - Research deputy
Street address
Golgasht street
City
Tabriz
Postal code
11851665
Approval date
2010-08-10, 1389/05/19
Ethics committee reference number
8917
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
symptom severity
Timepoint
for three months; first tow days of menstrual cycle in spasmodic dysmenorrhea, two days before menstrual bleeding in congestive dysmenorrhea
Method of measurement
Symptom Severity Scale (SSS)
Secondary outcomes
1
Description
rest lenght
Timepoint
for three months; first tow days of menstural cycle in spasmodic dysmenorrhea, two days before menstural bleeding in congestivedysmenorrhea
Method of measurement
reported rest lenght (hour) by participant
Intervention groups
1
Description
Intervention group: An expert in acupressure will instruct method of pressure to the participants and will ask them to use this method during dysmenorrhea. Every paricipant should press sp6 point by her thumb for 5 minutes (periods of 6 seconds pressure and 2 seconds rest), until the participant will feel heaviness and numbness around sp6 point. After every 5 minutes the leg will be changed and this procedure will be done on the other leg for 20 minutes (every leg will be pressed two periods of 5 minutes).
Category
Other
2
Description
Control group: Ibuprofen Tabs (400 mg) every 6 hours if needed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitories of Tabriz University of Medical Sciences & Tabriz University
Full name of responsible person
Sakineh Mohammad-Alizadeh
Street address
Nursing & Midwifery faculty
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahmood Nazar Pour
Street address
Next to Tourism Hotel, Jolfa
City
Jolfa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?