Effect of EX-PLISSIT model based couple counseling versus control group on self-concept and sexual satisfaction in infertile couples: a randomized clinical trial
To assess the effect of EX-PLISSIT model based couple counseling versus control group on self-concept and sexual satisfaction in infertile couples
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 60 infertile couples. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 40 years
Primary infertility
Obtaining a score of 0 to 64 based on sexual self-concept questionnaire
Obtaining a score of 17 to 67 based on the sexual satisfaction questionnaire
Exclusion criteria:
Any mental illness
Taking medications that affect sexual activity
Intervention groups
Intervention group:
Routine treatment of infertility in addition to EX-PLISSIT model based couple counseling, including face-to-face sessions with infertile couples for one hour once a week for 4 weeks (including describing the anatomy and physiology of the female sexual organ; the stages of the sexual cycle and sexual performance; the definition of sexual self-concept and its types; the effect sexual self-concept on married life and sexual relations; the effects of negative sexual self-concept on pregnancy, the effect of sexual self-concept on sexual satisfaction; the effect of spouse's behavior on the sexual self-concept of an infertile woman and vice versa; the role of mental beliefs and psychological factors on sexual satisfaction and activity and factors affecting sexual desire)
Control group:
Just routine treatment of infertility
Main outcome variables
Primary outcome:
The score of sexual self-concept
The score of sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N443
Registration date:2022-09-13, 1401/06/22
Registration timing:prospective
Last update:2022-09-13, 1401/06/22
Update count:0
Registration date
2022-09-13, 1401/06/22
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
2022-09-23, 1401/07/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of EX-PLISSIT model based couple counseling versus control group on self-concept and sexual satisfaction in infertile couples: a randomized clinical trial
Public title
Effect of EX-PLISSIT model based couple counseling versus control group on self-concept and sexual satisfaction in infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 40 years
Primary infertility
Obtaining a score of 0 to 64 based on sexual self-concept questionnaire
Obtaining a score of 17 to 67 based on the sexual satisfaction questionnaire
Exclusion criteria:
Any mental illness
Taking medications that affect sexual activity
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.UMSHA.REC.1401.461
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
The score of sexual self-concept
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
Using Snell's standard questionnaire of sexual self-concept
2
Description
The score of sexual satisfaction
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
Using Lindaberg's standard sexual satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment of infertility in addition to EX-PLISSIT model based couple counseling, including face-to-face sessions with infertile couples for one hour once a week for 4 weeks (including describing the anatomy and physiology of the female sexual organ; the stages of the sexual cycle and sexual performance; the definition of sexual self-concept and its types; the effect sexual self-concept on married life and sexual relations; the effects of negative sexual self-concept on pregnancy, the effect of sexual self-concept on sexual satisfaction; the effect of spouse's behavior on the sexual self-concept of an infertile woman and vice versa; the role of mental beliefs and psychological factors on sexual satisfaction and activity and factors affecting sexual desire)
Category
Treatment - Other
2
Description
Control group: Just routine treatment of infertility
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Raziyeh Dalvand
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
raziyehdalvand07@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Raziyeh Dalvand
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
raziyehdalvand07@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Arezoo Shayan
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
arezoo.shayan2012@yahoo.com
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