The purpose of this randomized clinical trial is to examine the effect of sex education package on the sexual function of nulliparous pregnant women in the first trimester. The statistical population of this research includes all the nulliparous women who go to prenatal clinic of Lolagar and Arash hospital of Tehran to receive routine prenatal care. This study will be on 100 Nulliparous pregnant women who are in the first trimester, and who are qualified to participate for this research. The main inclusion criteria involves not being prohibited by medical reason to have sexual activity, not using the medicines effecting their individual sexual response; and the main exclusion criteria involves abortion, and hyperemesis gravidarum. After taking a written testimonial, the researcher asked the qualified women to fill the questionnaires of demographic information, midwifery information, and the female sexual function index. Randomly and every other week, the participants are assigned to two groups of intervention and control. In the intervention group, participants will be trained about sexual health during pregnancy, using training book and CDs which are provided by the research team. The control group will receive routine prenatal care. Training session will be held once a week, for two sequential weeks and each for 60 minutes. Training book and CDs will be given to the pregnant women at the end of the first session. The participants and their husbands can be counseled for sexual health via telephone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081123590N1
Registration date:2015-09-25, 1394/07/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-25, 1394/07/03
Registrant information
Name
Leila Norouzi
Name of organization / entity
Faculty Of Medical Seinces, Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3809
Email address
l.norouzi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2014-05-10, 1393/02/20
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of sex education package on sexual function on nulliparous pregnant women in the first trimester
Public title
The effect of sex education package on sexual function of nulliparous pregnant women in the first trimester
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous pregnant women in the first trimester; No contraindication for sexual activity due to medical reasons, like: threatened abortion, inevitable abortion, history of infertility, multiple pregnancy; No history of addiction or habitual alcohol consumption by the woman and/or her husband; Not currently taking drugs that may affect on sexual response (Anti-hypertension, Thiazide diuretics, Anti-depression, Anti-histamines, Barbiturates, Narcotics, Diazepines, Amphetamines, Cocaine); Not currently suffering from physical or psychological disease; Not known disorder in sexual function; No severe emotional stress in past 3 months; Live with a permanent spouse; At least literate; Be iranian
Exclusion criteria: Abortion; Hyperemesis gravidarum; No sexual activity
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tarbiat Modares University
Street address
Jalal Ale Ahmad and Shahid Chamran Highways, Tarbiat Modares University, Tehran, Iran
City
Tehran
Postal code
14115-111
Approval date
2013-11-30, 1392/09/09
Ethics committee reference number
52/4996 د
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 week after intervention
Method of measurement
Female Sexual Function Index (FSFI) that will be self administered
Secondary outcomes
1
Description
Pregnancy anxiety
Timepoint
Before intervention, 4 week after intervention
Method of measurement
Pregnancy Related Anxiety Questionnaire (PRAQ) that will be self administered
Intervention groups
1
Description
Intervention group: implementation of a sex education package. At first, group education will be conducted in groups with 8-10 women in the selected prenatal 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 education in sexual health in pregnancy, will teach at the sessions using an educational book and compact disk Compiling by the research team. The book and compact disk 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: Routine prenatal care
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Lolagar Hospital
Full name of responsible person
Leila Norouzi
Street address
Khosh Street, Between Azerbaijan and Dampezeshki Streets, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Roentan Arash Hospital
Full name of responsible person
Leila Norouzi
Street address
Baghdarnia Street, Farjam Street, Tehranpars Second Square, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Yaaghob Fathollahi
Street address
Jalal Ale Ahmad and Shahid Chamran Highways, Tarbiat Modares University, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Leila Norouzi
Position
Postgraduate Student of Midwifery
Other areas of specialty/work
Street address
Jalal Ale Ahmad and Shahid Chamran Highways, Tarbiat Modares University, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8288 3809
Fax
Email
l.norouzi@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Minoor lamyian
Position
Associate Professor
Other areas of specialty/work
Street address
Jalal Ale Ahmad and Shahid Chamran Highways, Tarbiat Modares University, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8288 3809
Fax
Email
lamyianm@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Leila Norouzi
Position
Postgraduate Student of Midwifery
Other areas of specialty/work
Street address
Jalal Ale Ahmad and Shahid Chamran Highways, Tarbiat Modares University, Tehran, Iran
City
Tehran
Postal code
Phone
+98 82883809
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)