The aim of this randomized controlled trial is to determine the effect of a sex education package on sexual beliefs and function in pregnant women. We will recruit 22 pregnant women from each of the four selected public health centers in Karaj, Iran. After getting written informed consent, participants will complete a self-administered questionnaire about demographic and reproductive history and questions about sexual beliefs and function. Then we will randomly allocate them into intervention and control groups with assignment ratio of 1:1 using permuted block randomization with block sizes of 4 and 6 concealed in sequentially numbered, sealed, opaque envelopes. We will implement the sexual education in the intervention group and a nutritional education in the control group. The groups will be educated in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife with special short education in sexual health in pregnancy, will teach at the interventional group sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The subjects and their husbands in the interventional group can also get telephone counseling about sexual health. The participants will complete post -test questionnaires in three time points, 4 weeks after intervention, 24-28 weeks gestational age, and 36-40 weeks gestational age.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105163706N7
Registration date:2011-07-19, 1390/04/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-07-19, 1390/04/28
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-07-27, 1390/05/05
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a sex education package on sexual beliefs and function in pregnant women: a randomised controlled trial
Public title
Effect of a sex education package on sexual beliefs and function in pregnant women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 1- Pregnant women in 8-14 weeks of pregnancy 2- Having family health records in Karaj city health centers. 3-No contraindication for sexual activity due to medical reasons, like: threatened abortion, twin pregnancy, history of habitual abortion or incompetent cervix, history of infertility, history of preterm labor or PROM. 4-No history of addiction or habitual alcohol consumption by the woman and/or her husband. 5-Not currently taking drugs that may affect on sexual response (anti-hypertension, Thiazide diuretics, anti-depression, anti-histamines, Barbiturates, narcotics, diazepines, amphetamines, cocaine. 6-Not currently suffering from physical or psychological disease. 7-Not known disorder in sexual function 8-No severe emotional stress in past 3 months 9-Be able to fill in the questionnaire. 10- live with a permanent spouse.
Exclusion criteria: occurrence of severe emotional stress; conditions which need to restrict sexual activity and starting to take drugs which may affect sexual response.
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:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research deputy-Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
51665118
Approval date
2011-06-12, 1390/03/22
Ethics committee reference number
915
Health conditions studied
1
Description of health condition studied
Sex education in pregnancy
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual function
Timepoint
Before intervention, 4 weeks after intervention, in 24-28 weeks of pregnancy,in 36-40 weeks of pregnancy
Method of measurement
Female Sexual Function Index (FSFI) that will be self-administered and will be put into a sealed box
Secondary outcomes
1
Description
Sexual beliefs and function in pregnant women
Timepoint
Before intervention, 4 weeks after intervention, in 24-28 weeks of pregnancy,in 36-40 weeks of pregnancy
Method of measurement
Through self-made questionnaire in sexual beliefs and sexual function in pregnancy that will be self-administered and will be put into a sealed box
Intervention groups
1
Description
Intervention group: implementation of a sex education package, i.e. At first, group education will be conducted in groups with 5-11 women in the selected health centers in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife with special short education in sexual health in pregnancy, will teach at the sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The women will be asked to study the book (themselves and their husbands) till the second educational session and ask their questions in the session. The subjects and their husbands in the interventional group can also get telephone counseling about sexual health.
Category
Lifestyle
2
Description
Control group: implementation of a nutritional education package, i.e. At first, group education will be conducted in groups with 5-11 women in the selected health centers in two sessions, approximately sixty minutes each session, once a week for two consecutive weeks. One of the research team members, a midwife will teach at the sessions using an educational book written by the research team. The book will be given to the pregnant women at the end of the first session. The women will be asked to study the book (themselves and their husbands) till the second educational session and ask their questions in the session. The subjects and their husbands in the interventional group can also get telephone counseling about nutrition.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Fardis Shohada
Full name of responsible person
Malihe Afshar
Street address
Fardis Sq. West Canal
City
Karaj
2
Recruitment center
Name of recruitment center
Fardis Valyasr
Full name of responsible person
Malihe Afshar
Street address
Anbar Naft Square
City
Karaj
3
Recruitment center
Name of recruitment center
Tabatabaie
Full name of responsible person
Malihe Afshar
Street address
Mohamad shahar-Bakhtyari street
City
Karaj
4
Recruitment center
Name of recruitment center
Meshkin dasht
Full name of responsible person
Malihe Afshar
Street address
Shahid Hemmatkar street
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Research deputy, Tabriz university of medical sciences, Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz Univercity of Medical Sciences, Faculty of nursing and midwifery
Full name of responsible person
Malihe Afshar
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, south shariati
City
Tabriz
Postal code
Phone
+98 41 1555 8876
Fax
Email
mlh.afshar@gmail.com; ma_af_afshar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of nursing and midwifery, Tabriz university of medical sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Assistant professor/PhD in Reproductive Health
Other areas of specialty/work
Street address
Faculty of nursing and midwifery,South Shariati
City
Tabriz
Postal code
Phone
+98 41 1477 2699
Fax
Email
smoalch@yahoo.com
Web page address
alizades@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Facultiy of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person
Malihe Afshar
Position
Master of sciences student in midwifery
Other areas of specialty/work
Street address
Facultiy of Nursing and Midwifery, South Shariati
City
Tabriz
Postal code
Phone
+98 26 1222 1400
Fax
Email
mlh.afshar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)