Abstract
Objective:This study was designed to compare the analgesic effect of Heat Pach containing Iron Chip with ibuprofen for primary dysmenorrhea.
Inclution Criteria: pain or cramp during mensturation; unable to relieve pain and suffering.
Exclution criteria: The history of severe menstrual bleeding; body mass index(BMI)> 30;
medical and mental illness ; and smoking (cigarettes, ...) ; use of oral contraceptive; unpleasant event or death of near family ; and continous exercise(during the past six months); scratch the skin in the lower abdomen;vaginal infection Population: university student
Sample size:147
Intervention: The participants were randomly assigned into one of the intervention groups (Heat Pach and Ibuprofen), heat pach attached lower abdomen skin in group 1, and ibuprofen used in group2 , if dysmenorrhea untreated, use of ibuprofen after 8 hours .
Time intervention: initial menstruation Heat Pach during 8 hr and Ibuprofen q8hr
Primary outcome measure: intensity primary dysmenorrhea on 2,4,8,12,and 24 hr after initial menstruation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107187038N2
Registration date:2011-08-15, 1390/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-15, 1390/05/24
Registrant information
Name
Shahin Dokht Navvabi-Rigi
Name of organization / entity
Zahedan University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 1242 1259
Email address
navabi_rigi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Research Of Zahedan University Of Medical Science
Expected recruitment start date
2007-11-01, 1386/08/10
Expected recruitment end date
2008-12-30, 1387/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison Of the effect of Heat Patch and Ibuprofen On Intensity primary Dysmenorrhea In The Students' Zahedan University Of Medical Science
Public title
Effect of heat patch on dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclution Criteria: pain or cramp during mensturation; unable to relieve pain and suffering.
Exclution criteria: The history of severe menstrual bleeding; body mass index(BMI)> 30;
medical and mental illness ; and smoking (cigarettes, ...) ; use of oral contraceptive; unpleasant event or death of near family ; and continous exercise(during the past six months); scratch the skin in the lower abdomen;vaginal infection
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
147
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
Zahedan University Of Medical Science
Street address
Deputy Research; Pardis Of Zahedan university Of Medical Science; Meidan Dr Hesabi; Zahedan; Sistan & Bluchestan; Iran
City
Zahedan
Postal code
Approval date
2011-07-31, 1390/05/09
Ethics committee reference number
90002
Health conditions studied
1
Description of health condition studied
primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
primary dysmenorrhea
Primary outcomes
1
Description
Intensity Primary Dysmenorrhea
Timepoint
initial 2-4-8-12-24hr
Method of measurement
MCGILL questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Heat pach group:one pach during initial pain apply on lower abdomen to 8 h,after the demand use of ibuprofen
Category
Prevention
2
Description
control group:400 mg ibuprofen q 8 h
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory student(deputy of research)
Full name of responsible person
Sodabeh Hashemzehi
Street address
Zahedan University of medical science
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy Research Of Zahedan University Of Medical Science
Full name of responsible person
Sodabeh Hashemzehi
Street address
Pardis -Zahedan University Of Medical Science; Meidan Dr Hesabi; Zahedan; Sistan & Bluchestan; Iran
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Research Of Zahedan 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
Zahedan University of medical science
Full name of responsible person
Shahin-Dokht Navvabi-Rigi
Position
mastery of midwifery
Other areas of specialty/work
Street address
Post box1379; Nursing and Midwifery School; Meidan Mashahir; Zahedan; Sistan and Bluchestan; Iran
City
Zahedan
Postal code
Phone
+98 915 997 6642
Fax
Email
navabi_rigi@zaums.ac.ir shahinnavabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University Of Medical Science
Full name of responsible person
Shahin-Dokht Navvabi-Rigi
Position
Tutor
Other areas of specialty/work
Street address
Post box1379; Nursing and Midwifery School; Meidan Mashahir; Zahedan; Sistan and Bluchestan; Iran
City
Zahedan
Postal code
Phone
+98 54 1242 1259
Fax
Email
navabi_rigi@zaums.ac.ir shahinnavabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University Of Medical Science
Full name of responsible person
Shahin-Dokht Navvabi-Rigi
Position
tutor
Other areas of specialty/work
Street address
Post box1379; Nursing and Midwifery School; Meidan Mashahir; Zahedan; Sistan and Bluchestan; Iran
City
Zahedan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)