Effect of group therapy based on the mutual behavioral analysis versus no group therapy on marital satisfaction and resilience in infertile women: a randomized clinical trial
To assess the effect of group therapy based on mutual behavioral analysis versus no group therapy on marital satisfaction and resilience in infertile women
Design
Design: This is a randomized clinical trial, in which 30 eligible infertile women will to the intervention and control groups
Settings and conduct
The eligible infertile women who will refer to Mahdieh Hospital in Tehran City during the study period will in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Infertility;
Literate
Exclusion criteria:
Mental disorders
Intervention groups
Intervention group: Routine counseling and group therapy based on mutual behavioral analysis 2 hours a week for 8 weeks
Control group: Just routine counseling
Main outcome variables
Primary outcome:
Assessing the marital satisfaction before intervention and 8 weeks after intervention using the standard questionnaire
Assessing the resilience before intervention and 8 weeks after intervention using the standard questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N255
Registration date:2018-12-20, 1397/09/29
Registration timing:retrospective
Last update:2018-12-20, 1397/09/29
Update count:0
Registration date
2018-12-20, 1397/09/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-09-18, 1397/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group therapy based on the mutual behavioral analysis versus no group therapy on marital satisfaction and resilience in infertile women: a randomized clinical trial
Public title
Effect of group therapy based on the mutual behavioral analysis versus no group therapy on marital satisfaction and resilience in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Infertility;
Literate
Exclusion criteria:
Mental disorders
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots
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 Shahid Beheshti University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences, Niayesh Crossroad, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SBMU.PHNM.1396.759
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Assessing the marital satisfaction
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Using the standard questionnaire
2
Description
Assessing the resilience
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Using the standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine counseling and group therapy based on the mutual behavioral analysis 2 hours a week for 8 weeks
Category
Treatment - Other
2
Description
Control group: Just routine counseling
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital in Tehran City
Full name of responsible person
Atefeh Haghighi
Street address
School of Nursing and Midwifery, Niayesh Crossraod, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
haghighi.atefeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Moghimi
Street address
Shahid Beheshti University of Medical Sciences, Niayesh Crossroad, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
info.research@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Haghighi
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Niayesh Crossraod, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
haghighi.atefeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Jamileh Mohtashami
Position
PhD in Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Niayesh Crossraod, Valiasr Ave.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
j_mohtashami@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available