This study aimed to determine the effect of sexual health education on sexual function in primigravida women.
Design
This study is a non-randomized, single-blind, clinical trial including: one intervention groups and one control group, (40 participants in each group). Eligible participants identified using the Integrated Health Record System (SIB). Initially, a list of the study population was generated from the SIB, including all primiparous pregnant women who met the inclusion criteria and were receiving prenatal care at the health center. A systematic sampling plan was implemented by selecting one sample from every five eligible woman from the list. Sample were assigned either to the intervention or control group (n = 43 in each group) based on their desire.
Settings and conduct
Setting: Shahid Beheshti Comprehensive Urban and Rural Health Center.
Before the intervention, general parameters were recorded. The sexual function of women was assessed using the Female Sexual Function Index (FSFI). FSFI questionnaire was completed by the participants of both educational intervention and control group in three stages: before the intervention, four and eight weeks after the last training session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women of 18 to 45 years old, gestational age of 14-28 weeks, intended and singleton pregnancy, low-risk pregnancy.
Exclusion criteria: History of obstetric complications in recent pregnancy, chronic medical conditions and psychiatric disorders recorded according to the medical history or statements of the participant, addiction to drugs or psychotropic medications.
Intervention groups
This group received a comprehensive program comprising six 60-minute sessions, conducted in small groups of 3-5 individuals at the conference hall of the health center over two consecutive weeks.
Main outcome variables
The mean score of Sexual function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090810002324N20
Registration date:2025-04-08, 1404/01/19
Registration timing:retrospective
Last update:2025-04-08, 1404/01/19
Update count:0
Registration date
2025-04-08, 1404/01/19
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-14, 1398/08/23
Expected recruitment end date
2020-09-13, 1399/06/23
Actual recruitment start date
2019-12-21, 1398/09/30
Actual recruitment end date
2020-10-21, 1399/07/30
Trial completion date
2020-12-13, 1399/09/23
Scientific title
The effect of Sexual Health Education on the Sexual Function of Primigravid Women
Public title
Sexual Health Education on the Sexual Function of Primigravid Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age of 14-28 weeks, intended and singleton pregnancy, low-risk pregnancy (based on a medical record), stability in marital relationships (based on a demographic data).
Exclusion criteria:
History of obstetric complications (bleeding, spotting, ectopic pregnancy, twins, etc.) in recent pregnancy, chronic medical conditions and psychiatric disorders recorded according to the medical history or statements of the participant, addiction to drugs or psychotropic medications.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
86
Actual sample size reached:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The principal investigator and the statistician were blinded to the allocation of individuals into groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.IUMS.REC.1398.734
Health conditions studied
1
Description of health condition studied
The mean score of Sexual function
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The mean score of Sexual function
Timepoint
before the intervention, 4 and 8 weeks after the last training session.
Method of measurement
The Female Sexual Function Index (FSFI).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group received a comprehensive program comprising six 60-minute sessions, conducted in small groups of 3-5 individuals at the conference hall of the health center over two consecutive weeks. These sessions addressed various topics, such as the anatomy and physiology of the female reproductive system, changes in the sexual cycle during pregnancy, important aspects of female sexual stimulation, common misconceptions about sexual performance, appropriate sexual positions during pregnancy, the importance of maintaining optimal sexual function throughout pregnancy, and detailed explanations about sexual dysfunction.
Category
Prevention
2
Description
Control group: This group received no intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Comprehensive Rural and Urban Health Center
Full name of responsible person
afsaneh ghorbani
Street address
Poledokhtar-Emam street-Shahid Beheshti Comprehensive Rural and Urban Health Center
City
Pole Dokhtar
Province
Lorestan
Postal code
6851796448
Phone
+98 66 3222 8091
Email
afsanehq87@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Majid Safa
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
vcm@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
2. Ministry of Health and Medical Education
Full name of responsible person
Leila Allahqoli
Position
Senior reseacher
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahrak Qods, Simay Iran Street, between Flamak and Zarafshan
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8836 3600
Email
lallahqoli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Fax
+98 21 8820 1978
Email
MKmarkesh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Assiciate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery, Rashid Yasemi st., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Email
MKmarkesh@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available