This study will be done with aim to investigate the effectiveness of cognitive-behavioral consultation on the quality of life in women with polycystic ovary syndrome. This is an one blinded clinical trial. The study population will be included women with polycystic ovary syndrome admitted to Akbarabadi educational hospital in Tehran. A total of 50 eligible patients will be selected and randomly will be assigned in two intervention and control groups. Beginning the study quality of life questionnaire for patients with polycystic ovary syndrome (PCOQ) will be provided to both groups. The intervention group will received individually 10 sessions of 30 to 45-minute cognitive-behavioral counseling with 7 days intervals. Participants in the control group will be given pamphlet that its content is simple and rational in the case of introduction of the disease.
Before the first session and three weeks after the last session the quality of life of participants with the same scale will be measured and the two groups will be compared.
Inclusion criteria: Lack of endocrine disease or any other chronic illness; Lack of mental illness; Lack of medicine use and psychotropic substances and narcotic drugs; Minimum age 15 and maximum age of 40 years; The ability to read and write or speak Persian; Residence in Tehran.
Exclusion criteria: lack of participation in two or more sessions of counseling; unwillingness to participate in the continuation of the project.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021514333N69
Registration date:2017-03-04, 1395/12/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-04, 1395/12/14
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral consultation on the quality of life in women with polycystic ovary syndrome
Public title
Investigation of effectiveness of cognitive-behavioral consultation on the quality of life in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Lack of endocrine disease or any other chronic illness; Lack of mental illness; Lack of medicine use and psychotropic substances and narcotic drugs; Minimum age 15 and maximum age of 40 years; The ability to read and write or speak Persian; Residence in Tehran.
Exclusion criteria: lack of participation in two or more sessions of counseling; unwillingness to participate in the continuation of the project.
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2017-02-04, 1395/11/16
Ethics committee reference number
kums.rec.1395.634
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Quality of Life
Timepoint
Baseline and 3 weeks after the end of the study
Method of measurement
Based on the quality of life questionnaire for patients with polycystic ovary syndrome (PCOQ)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will received individually 10 sessions of 30 to 45-minute cognitive-behavioral counseling with 7 days intervals
Category
Behavior
2
Description
Participants in the control group will be given pamphlet that its content is simple and rational in the case of introduction of the disease
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbari Hospital
Full name of responsible person
Farzaneh Jalilian
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
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 research, 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
Farzaneh Jalilian
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3828 0642
Fax
Email
farzane@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. Marzieh
Position
Ph.D. in Reproductive Health
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 838279394
Fax
Email
fkaboudi@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
Farzaneh Jalilian
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3828 0642
Fax
Email
farzane@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)