Introduction: Polycystic ovary syndrome is the most common endocrine disorder in women of reproductive age. Promoting mental health of these women can improve the fertility and quality of life outcomes. Therefore, the purpose of this study was to implement an interventional program for mental health in women with PCOS. Materials and Methods: This is a clinical trial study. The researcher randomly assigned the research units into one of the two intervention or control groups and then designed the intervention on the intervention group and the results were collected by a 28-item general health questionnaire (GHQ-28) and compared to the control group. Discussion: It seems that the findings of this study are helpful in promoting the mental health of women with polycystic ovarian syndrome and improving the quality of life of these women in the community.
General information
Acronym
pcos
IRCT registration information
IRCT registration number:IRCT2017092736445N1
Registration date:2017-10-03, 1396/07/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Fatemah Zaremobini
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 7500
Email address
m_kamravamanesh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study has been approved by the ethics committee affiliated with Isfahan University of Medical Sciences, Isfahan, Iran
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
implement an interventional program for mental health in women with polycystic ovary syndrome
Public title
mental health for women with polycystic ovary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria
Inclusion criteria are women aged between 15-49 years, Iranian nationality, consent to participate in the study, ability to understand questions or ability to read and write, not being in stressful situations such as immigration, death of loved ones and financial problems in the past 6 months, not participating in any other clinical trials at the same time, no severe mental disorders that requires to be under medical treatment or hospitalization.
Exclusion criteria
The exclusion criterion is not completing the intervention for any reason such as severe life stress, the death of the spouse or immigration and so on.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Random table number was done for randomization and day by day.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan-hezar jarib street-Isfahan University Of Medical Sciences
City
Isfahan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2016-05-31, 1395/03/11
Ethics committee reference number
IR.MUI.REC. 1395.3.508
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
Mental health
Timepoint
before the intervention, 1 month after intervention, 3 month after intervention
Method of measurement
GHQ-28
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, an interventional program (education and supportive program) was performed for patients with polycystic ovary syndrome, and the usual care was taken for the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Mushtaq Infertility Center
Full name of responsible person
Fatemeh Zare Mobayeni, Ph.D. student of reproductive health
Street address
Esfahan, Bozorg Meher Square, Salman Fars Ave , Corner of Behesht Street, No. 23
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ziba Farajzadegan
Street address
Isfahan- Hezar Jarib Ave.- Isfahan University of Medical Sciences- Faculty of Medicine- Social Medicine Center-2nd Floor- Dr. Ziba Farajzadegan
City
Isfahan
Grant name
IR.MUI.REC
Grant code / Reference number
1395.3.508
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Fatemeh Zare Mobini
Position
Student of Reproductive Health, Faculty of Nursing and Midwifery, Isfahan University of Medical Scie
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Faculty of Nursing Midwifery, Ph.D Student Department, Fatemeh Zare Mobini
City
Isfahan
Postal code
Phone
+98 31 3792 7500
Fax
Email
fatemehzaremobini@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Ziba Farajzadegan
Position
Professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences - Department of Social Medicine, Faculty of Medicine
City
Isfahan
Postal code
Phone
+98 31 3668 0048
Fax
Email
z_farajzadegan1361@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fatemeh Zaremobini
Position
Student of Reproductive Health, Faculty of Nursing and Midwifery, Isfahan University of Medical Scie
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences- Faculty of Nursing Midwifery- Department of PhD Students- Fatemeh Zare Mobini
City
Isfahan
Postal code
Phone
Fax
Email
fatemehzaremobini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)