Objective: This study assesses The effect of the educational program on quality of life in PCOS women Design: randomized clinical trial will be conducted on 110 PCOS women in health centers in Hamadan city. They will be randomly assigned to intervention and control groups with regard to Allocation concealment (55 in intervention group and 55 in control group). Setting and conduct: The eligible women who refer to health centers in 2016 will be enrolled. Inclusion criteria consisted of women: A confirmed case of PCOS was diagnosed based on the case definition of the Rotterdam diagnostic criteria; being 18-45 years of age; married; Sexual Dysfunction (having a score of 28 and less in the Female Sexual Function Index questionnaire; no sexual problem or disabling disease in the spouse; not being previously diagnosed with psychiatric disorders and not using psychiatric medications; do not suffer from other chronic diseases affecting the quality of life; being able to read and write. Exclusion criteria: unwillingness to continue cooperation; the emergence of any known physical or psychological illness that affects the quality of life; occurrence of pregnancy. intervention : The Sexual education program will be given once a week for 4 weeks and in control group the educational program not will be prescribed. Main outcome measures: the two groups will be compared in terms of the quality of life by Cronin or PCOSQ before the intervention, two weeks after the intervention and 3 months after the intervention.
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2017-11-11, 1396/08/20
Expected recruitment end date
2018-02-09, 1396/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the educational program on quality of life in PCOS women in intervention and control groups
Public title
The effect of the educational program on quality of life in PCOS women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: A confirmed case of PCOS was diagnosed based on the case definition of the Rotterdam diagnostic criteria; being 18-45 years of age; married; Sexual Dysfunction (having a score of 28 and less in the Female Sexual Function Index questionnaire; no sexual problem or disabling disease in the spouse; not being previously diagnosed with psychiatric disorders and not using psychiatric medications; do not suffer from other chronic diseases affecting the quality of life; being able to read and write.
Exclusion criteria: unwillingness to continue cooperation; the emergence of any known physical or psychological illness that affects the quality of life; occurrence of pregnancy.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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 Tehran University of Medical Sciences
Street address
Nosrat st. Tohid sq. Tehran I.IRAN 141973317
City
Tehran
Postal code
1419733171
Approval date
2016-10-15, 1395/07/24
Ethics committee reference number
IR.TUMS.FNM.REC.1395.781
Health conditions studied
1
Description of health condition studied
Quality of life in PCOS women
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Health related quality of life
Timepoint
before the intervention, two weeks after intervention, 3 months after the intervention
Method of measurement
PCOSQ or Cronin Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:In The sexual education program once a week for 4 weeks will be given. The quality of life will be measured by PCOSQ before the intervention, two weeks after the intervention and 3 months after the intervention.
Category
Other
2
Description
Control: In control group the education program not will be prescribed. The quality of life will be measured by PCOSQ before the study,two weeks after the study and 3 months after the study. In order to observe ethical issues, at the end of the study, the control group can use sexual counseling.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Bita Fereidooni
Street address
hamadan. pasdaran street
City
Hamadan
2
Recruitment center
Name of recruitment center
Atieh hospital
Full name of responsible person
zahra nazary
Street address
hamadan madan township
City
Hamadan
3
Recruitment center
Name of recruitment center
Private Pars Dermatology Clinic
Full name of responsible person
dr samadi
Street address
buali street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences
Street address
16 Azar Street, Keshavarz Blvd
City
Tehran
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, Tehran 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
Tehran University of Medical Science
Full name of responsible person
Bita Fereidooni
Position
Phd student of Reproductive health
Other areas of specialty/work
Street address
Hakim hamadan no 34
City
Hamadan
Postal code
Phone
+98 818211025
Fax
Email
barshimah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahta behboodi moghadam
Position
PHD Reproductive health
Other areas of specialty/work
Street address
School of Nursing and Midwifery. Tehran University of Medical Sciences.
City
Tehran
Postal code
Phone
+98 219122494201
Fax
Email
bahar_behboodi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Bita Fereidooni
Position
phd student in reproductive health
Other areas of specialty/work
Street address
Hamadan hakim no 34
City
Hamadan
Postal code
Phone
+98 81 3821 1025
Fax
Email
barshimah@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)