This study is a randomized controlled trial study with one intervention and one control group. The aim of the study is the assessment of the effectiveness of cognitive behavioral counseling on sexual function of infertile women. Sampling will be done using convenience sampling method, and after recruiting eighty participants, random allocation will be done into control and intervention groups without blinding through simple randomization using random number table. Infertile women in this study are 20-45 years old with a history of at least 6 months of infertility.
Eight sessions of group counseling (10 -12 women in each group) will be conducted once a week. Data gathering will be done using a demographic form and FSFI questionnaire in three times; before, just after intervention, and followed 1 month later. Sexual function in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042031662N2
Registration date:2017-08-12, 1396/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-12, 1396/05/21
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Alborz University of Medical Sciences
Expected recruitment start date
2017-08-08, 1396/05/17
Expected recruitment end date
2017-11-08, 1396/08/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual counseling with cognitive behavioral approach on promoting sexual function of infertile women
Public title
The effect of sexual counseling with cognitive behavioral approach on promoting sexual function of infertile women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 20-45 years; married and having sexual practice; history of at least 6 months of infertility; not having adapted child; Iranian nationality and speaking to Farsi; education level of grade 9 and higher.
Exclusion criteria: menopause; known physical or mental illness; using medications that affect sexual function; IVF; get pregnant.
Age
From 20 years old to 45 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 Alborz University of Medical Sciences
Street address
North Taleghani St., Azimiyeh
City
Karaj
Postal code
Approval date
2016-06-06, 1395/03/17
Ethics committee reference number
Abzums.Rec.1395.29
Health conditions studied
1
Description of health condition studied
Sexual Function
ICD-10 code
Z70
ICD-10 code description
Counselling related to sexual attitude, behaviour and orientation
Primary outcomes
1
Description
Sexual function
Timepoint
before, just after, and 1 month after intervention
Method of measurement
FSFI questionnaure
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive 8 sessions sexual counseling based on cognitive behavioral approach weekly. Duration of each session is 90 minutes. Titles of counseling sessions include, anatomy and physiology of sexual tract, sexual response, relaxation techniques, exploring thoughts and emotions, Kegel exercise, sexual fantasies, and sensate focus.
Category
Behavior
2
Description
Control group will not receive routine care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouyesh Infertility Treatment Center
Full name of responsible person
Maryam Sahraiyan
Street address
No. 151, 18th Golestan St., North Taleghani St., Azimiyeh
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
North Taleghani street, Azimiyeh
City
Karaj
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, Alborz University of Medical Sciences