Objectives: The impact of individual counseling on quality of life in Women with cyclic mastalgia, (2)Design: a controlled clinical trial. Setting and conduct: This study Will be perfomed on 80 women with cyclic mastalgia in Karaj, who are eligible to enter the study. The McGill Pain Questionnaire and WHO Questionnaire are used to assess quality of life, (3)Setting and conduct: In order to randomize, a two-stage cluster random sampling method will be used to select the centers.This means that the city will be divided into 5 regions and one health center will be selected from each region. Sample individuals will be selected randomly from these centers and using the random allocation method, will be divided into two groups of intervention and control. Before the intervention and one month after the intervention, the questionnaires will be completed by the two groups and the results will be compared with each other, (4) Participants including major eligibility criteria: Inclusion criteria: pain score ≥ 4; pain duration >5 days; 20-year interval to premenopausal state; regular menstruation cycle, Exclusion criteria: Pregnancy;lactation; patient with psychological and somatic disease; The history of breast cancer in the patient and her family; Patients who have been treated for breast pain for the last three months; using Hormonal contraceptives, (5) Intervention: individual counseling (6) main outcome measures (variables): quality of life in Women with cyclic mastalgia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100236513N1
Registration date:2017-10-26, 1396/08/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-26, 1396/08/04
Registrant information
Name
Solmaz Fakhravar
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3442 5647
Email address
s.fakhravar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research - Qazvin University of Medical Science
Expected recruitment start date
2017-09-03, 1396/06/12
Expected recruitment end date
2017-11-03, 1396/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of individual counseling on quality of life in Women with cyclic mastalgia
Public title
The impact of individual counseling on quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pain score ≥ 4; pain duration >5 days; 20-year interval to premenopausal state; regular menstruation cycle, Exclusion criteria: Pregnancy;lactation; patient with psychological and somatic disease; The history of breast cancer in the patient and her family; Patients who have been treated for breast pain for the last three months; using Hormonal contraceptives
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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, Bahonar Boulevard,Qazvin
Control group: at first the Mcgill pain questionnaire and WHO quality of life brief questionnaire to assess the quality of life will be completed in control group. In this group the subjects won’t be given counseling and special training. Finally, a month after the last session of the counseling Mcgill pain questionnaire and WHO quality of life brief questionnaire will be completed by subjects and level of quality life will be assessed.
Category
Lifestyle
2
Description
Intervention group, at first the Mcgill pain questionnaire and WHO quality of life brief questionnaire to assess the quality of life will be completed by intervention group. Then they will be participated in the counseling sessions. Research units participate in consultation meetings that will be 3 sessions of individual counseling with intervals of 2 days. The duration of sessions are 45 to 60 minutes. Finally, a month after the last counseling session level of quality of life will be assessed.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Javadolaemeh Comprehensive health service center
Full name of responsible person
Solmaz Fakhravar
Street address
City
Karaj
2
Recruitment center
Name of recruitment center
Sabzehparvar Comprehensive health service center
Full name of responsible person
Solmaz Fakhravar
Street address
City
Karaj
3
Recruitment center
Name of recruitment center
Sesarak bala Comprehensive health service center
Full name of responsible person
Solmaz Fakhravar
Street address
City
Karaj
4
Recruitment center
Name of recruitment center
Anbari Comprehensive health service center
Full name of responsible person
Solmaz Fakhravar
Street address
City
Karaj
5
Recruitment center
Name of recruitment center
Emam Hasan Mojtaba Comprehensive health service center
Full name of responsible person
solmaz fakhravar
Street address
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard, Qazvin
City
Qazvin
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 of Qazvin 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
Qazvin University Of Medical Sciences
Full name of responsible person
Solmaz Fakhravar
Position
Masters student
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 7267
Fax
Email
s.fakhravar@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Solmaz Fakhravar
Position
Masters student
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 7267
Fax
Email
s.fakhravar@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Solmaz Fakhravar
Position
Masters student
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Bahonar Boulevard, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3323 7267
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)