The title of this research will be the study of the effects of melatonin and meloxicam on sleep quality and pain severity in patients with primary dysmenorrhea, The Objectives of this research will be the determine the most appropriate treatment to pain decrease and improve sleep quality in patients, The design of this research will be done based on clinical trial in this way that qualified women will be selected through of the questionnaire and careful clinical interview to the numbers of 42 people and they will be divided by the method of random numbers table to the 3 equal groups, Major Inclusion criteria: Women 18 to 35 years old and nulipar; Regular cycles 21 to 35 days; Normal BMI 19.8 to 25; Medicines and certain supplements and herbal medicines dont use before and during of the study, Exclusion criteria: Secondary dysmenorrhea from pelvic disorders; chronic diseases; Mental disorders; Lack of consent of the person to continue participating in the study, The treatment interventions will be by using of 2 group of drugs, melatonin 3 mg and meloxicam 7.5mg, once at night for 5 night in the menstrual cycles before intervention and during intervention and to control group is doing intervention in the same way with placebo. Main outcome measures variables consist of dysmenorrhea pain severity and sleep Quality that will be measured through McGill pain ruler and pitsburg questionnaire and the findings will be analyzed by Spss softwave
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015031521475N1
Registration date:2015-07-10, 1394/04/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-10, 1394/04/19
Registrant information
Name
Fariba Mahmoudzadeh
Name of organization / entity
kermanshah University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 84 3334 2021
Email address
f.mahmoudzadeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for reserch,Kermanshah University of Medical Science
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effects of Melatonin and Meloxicam on sleep quality and pain severity in patients with primary dysmenorreh
Public title
Primary Dysmenorreh pain severity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women 18 to 35 years old and nulipar; Regular cycles 21 to 35 days; Normal BMI 19.8 to 25; Medicines and certain supplements and herbal medicines not used in before and during of the study, Exclusion criteria: Secondary dysmenorrhea from pelvic disorders; Chronic diseases; Mental disorders; Lack of person satisfaction in order to participating continue in the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The Volunteers will be selected through of the questionnaire and clinical interview to the numbers of 42 people and they will be divided through table of random numbers (assigned 2 digits code and fingerings on the above table) to the 3 groups equal
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Kermanshah University Of Medical Sciences
Street address
Beheshti Street
City
Kermanshah
Postal code
6715847141
Approval date
2015-05-26, 1394/03/05
Ethics committee reference number
kums.rec.1394.22
Health conditions studied
1
Description of health condition studied
Primary Dysmenorreh
ICD-10 code
N94-4
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
Dysmenorreh Pain Severity
Timepoint
The menstrual cycle before intervention and during intervention for 5 night
Method of measurement
According to the Mac Gill pain scale ruler
2
Description
Quality Of Sleep
Timepoint
The menstrual cycle before intervention and during intervention for 5 night
Method of measurement
According to the results Acti graphic
Secondary outcomes
1
Description
BMI
Timepoint
The menstrual cycle before intervention and during intervention for 5 night
Method of measurement
The result of dividing weight on the square of height
2
Description
Bed Time
Timepoint
The menstrual cycle before intervention and during intervention for 5 night
Method of measurement
According to the results Acti graphic
3
Description
The Duration Of Sleep
Timepoint
The menstrual cycle before intervention and during intervention for 5 night
Method of measurement
According to the results Acti graphic
4
Description
Waking At Night
Timepoint
The menstrual cycle before intervention and during intervention for 5 night
Method of measurement
According to the results Acti graphic
Intervention groups
1
Description
Control group : Folic Acid 10 mg with Folate brand name of pharmaceutical manufacturer Mehr, Once at night for 5 night in the menstrual cycles before intervention and time intervention
Category
Placebo
2
Description
Intervention group 1 : Melatonin 3 mg of pharmaceutical manufacturer seppid drug, Once at night for 5 night in the menstrual cycles before intervention and time intervention, Chemical combination acetyl 5 methoxy triptamine
Category
Treatment - Drugs
3
Description
Intervention group 2 : Meloxicam 7.5 mg of Manufacturer compani Loghman with mubik brand name, Once at night for 5 night, in the menstrual cycles before intervention and time intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bustan Dormitory, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Fariba Mahmoudzadeh, Assistant Professor of Obstetrics and Gynecology
Street address
Zekaria Razi Street, Rudaki Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reserch of Kermanshah University Of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
No 2, Beheshti Street
City
Kermanshah
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reserch of Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farahnaz Keshavarzi
Position
Associate member of the faculty of the department of Obstetrics and Gynecology Kermanshah، Felluship
Other areas of specialty/work
Street address
Zekaria Razi Street, Rudaki Street
City
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6331
Fax
+98 83 3428 1328
Email
Farahnaz Keshavarzi @yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Fariba Mahmoudzadeh
Position
Assistant Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Bustan Dormitory, Zekaria Razi Stree, Rudaki Street
City
Kermanshah
Postal code
6715847141
Phone
+98 83 3428 1374
Fax
+98 83 3428 1328
Email
F.Mahmoudzadeh@Kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farahnaz Keshavarzi
Position
Associate Professor Faculty of Obstetrics and Gynecology، Felluship Obstetrics and Gynecology
Other areas of specialty/work
Street address
Zekaria Razi Street, Rudaki Street
City
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Fax
+98 83 3428 1328
Email
Farahnaz Keshavarzi @yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)