Effect of sexual counseling based on the EX-PLISSIT model versus control group on help-seeking and sexual health literacy of newly married women: a randomized clinical trial
To assess the effect of sexual counseling based on the EX-PLISSIT model versus control group on help-seeking and sexual health literacy of newly married women
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Comprehensive Health Centers in Hamadan city, involving 106 eligible newly married women. The patients will be randomly assigned to the intervention and control groups through the block randomization. It should be noted that blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 40 years
Newly married women in the last year
First marriage
Iranian nationality
Being literate
Exclusion criteria:
Having a child
Being pregnant
History of hip surgery
Intervention groups
Intervention group:
Reproductive health care in addition to sexual counseling sessions based on the EX-PLISSIT model for 45 to 60 minutes once a week for four weeks
Control group:
Reproductive health care
Main outcome variables
Primary outcome:
Sexual health literacy
Help-seeking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N537
Registration date:2024-11-09, 1403/08/19
Registration timing:prospective
Last update:2024-11-09, 1403/08/19
Update count:0
Registration date
2024-11-09, 1403/08/19
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
2025-01-24, 1403/11/05
Expected recruitment end date
2025-09-27, 1404/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sexual counseling based on the EX-PLISSIT model versus control group on help-seeking and sexual health literacy of newly married women: a randomized clinical trial
Public title
Effect of sexual counseling based on the EX-PLISSIT model versus control group on help-seeking and sexual health literacy of newly married women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 40 years
Newly married women in the last year
First marriage
Iranian nationality
Being literate
Exclusion criteria:
Having a child
Being pregnant
History of hip surgery
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:
106
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired 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, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2024-10-26, 1403/08/05
Ethics committee reference number
IR.UMSHA.REC.1403.519
Health conditions studied
1
Description of health condition studied
Reproductive health
ICD-10 code
O09.2
ICD-10 code description
Supervision of pregnancy with other poor reproductive or obstetric history
Primary outcomes
1
Description
Sexual health literacy
Timepoint
Before the intervention and one month later
Method of measurement
Using the Sexual Health Literacy Questionnaire (SHLQ)
2
Description
Help-seeking
Timepoint
Before the intervention and one month later
Method of measurement
Using the General Help-Seeking Questionnaire (GHSQ) and the Actual Help-Seeking Questionnaire (AHSQ) and
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Reproductive health care in addition to sexual counseling sessions based on the EX-PLISSIT model for 45 to 60 minutes once a week for four weeks (including: getting to know the anatomy and physiology of the reproductive system, expressing the participants' desires, needs and beliefs about sex, explaining the areas of sexual performance and its changes in different periods and ages of fertility, explaining the four stages of the sexual response cycle and the physical and psychological differences between men and women, familiarizing with sexual disorders, explaining the factors affecting sexual relations and correcting misconceptions about sexual relations, familiarity with diseases transmitted through sexual contact, improving mental skills to strengthen and stimulate sexual stimulation in women and training skills to create variety in sexual relations, explaining the factors affecting sexual satisfaction and marital satisfaction)
Category
Prevention
2
Description
Control group: Reproductive health care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Dr. Azita Tiznobeik
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azita.tizno@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, 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
Sarah Hajizadegan Bidgoli
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
hajizadegan2001@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Azita Tiznobeik
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, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
azita.tizno@gmail.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, 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