Effect of couple-centered counseling based on EX-PLISSIT model versus control group on sexual function and satisfaction of couples in pregnant women with sexual dysfunction: a randomized clinical trial
To assess the effect of couple-centered counseling based on EX-PLISSIT model versus control group on sexual function and satisfaction of couples in pregnant women with sexual dysfunction
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 Comprehensive Health Centers in Hamadan city on 80 eligible pregnant women with sexual dysfunction. 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 45 years
Singleton pregnancy
Gestation age 24 to 28 weeks
Sexual dysfunction
Secondary education and more
Exclusion criteria:
Depressive disorder
Pregnancy complications such as gestational diabetes, preeclampsia, bleeding, premature rupture of the amnion sac
Intervention groups
Intervention group:
Routine care during pregnancy plus couple-oriented counseling based on the IX-PLISSIT model, one session per week for 45 to 60 minutes for 4 weeks including: false thoughts and beliefs about sexual contact during pregnancy, anatomy and physiology of the reproductive system, cycle sexual response in men and women, sexual desire changes during pregnancy, optimal position of intimacy during pregnancy, factors that reduce sexual desire
Control group:
Just routine care during pregnancy
Main outcome variables
Primary outcome:
Sexual function
Sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N442
Registration date:2022-09-11, 1401/06/20
Registration timing:prospective
Last update:2022-09-11, 1401/06/20
Update count:0
Registration date
2022-09-11, 1401/06/20
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
2022-09-21, 1401/06/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of couple-centered counseling based on EX-PLISSIT model versus control group on sexual function and satisfaction of couples in pregnant women with sexual dysfunction: a randomized clinical trial
Public title
Effect of couple-centered counseling based on EX-PLISSIT model versus control group on sexual function and satisfaction of couples in pregnant women with sexual dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45 years
Singleton pregnancy
Gestation age 24 to 28 weeks
Sexual dysfunction
Secondary education and more
Exclusion criteria:
Depressive disorder
Pregnancy complications such as gestational diabetes, preeclampsia, bleeding, premature rupture of the amnion sac
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Routine care during pregnancy plus couple-oriented counseling based on the IX-PLISSIT model, one session per week for 45 to 60 minutes for 4 weeks including: false thoughts and beliefs about sexual contact during pregnancy, anatomy and physiology of the reproductive system, cycle sexual response in men and women, sexual desire changes during pregnancy, optimal position of intimacy during pregnancy, factors that reduce sexual desire
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
2020-10-03, 1399/07/12
Ethics committee reference number
IR.UMSHA.REC.1399.549
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
Using the Female Sexual Function Index (FSFI) questionnaire
2
Description
Sexual satisfaction
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
Using the Lindaberg Sexual Satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care during pregnancy plus couple-oriented counseling based on the IX-PLISSIT model, one session per week for 45 to 60 minutes for 4 weeks including: false thoughts and beliefs about sexual contact during pregnancy, anatomy and physiology of the reproductive system, cycle sexual response in men and women, sexual desire changes during pregnancy, optimal position of intimacy during pregnancy, factors that reduce sexual desire
Category
Treatment - Other
2
Description
Control group: Just routine care during pregnancy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Mahsa Fatahi
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
mahsa.ff1996@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
Mahsa Fatahi
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
mahsa.ff1996@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Zahra Masoomi
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
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
zahramid2001@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