The aim of this randomized clinical trial, single blind,is to determine the Effect of group sexual counseling on belief, attitude and quality of the marital relationship in pregnant women.This study will be carried out on 100 pregnant women referred to 5 public health centers in Zahedan؛ Iran. (20 pregnant women in each center). Researcher from all eligible women؛ after getting informed consent will request to complete self-administered questionnaire about demographic and Sexual behavior and questions about sexual beliefs and attitudes in pregnancy and Perceived Relationship Quality components questionnaire. Then we will randomly allocate them into intervention and control groups. We will implement the sexual counseling in the intervention group and will be received only routine care in the control group. The group counseling will be held in 5 sessions of 90 minutes, three times a week during two consecutive weeks.
In first session: anatomy and physiology of the female and male reproductive system, physical and psychological changes during pregnancy, second session: Natural sexual response cycle and changes in sexual patterns during pregnancy .the third session: attitudes and beliefs about sex in pregnancy, the fourth session:Change negative attitudes and beliefs about sexual activity in pregnancy and in Fifth Session will be described about Safe sex.The participants will complete post -test questionnaires in 6 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061322695N1
Registration date:2015-08-06, 1394/05/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Parvin Soltani
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
p_soltani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- chancellor research & technology , Zahedan University Of Medical Science
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group sexual counseling on belief, attitude and quality of the marital relationship of pregnant women .
Public title
Effect of group sexual counseling on belief, attitude and quality of the marital relationship of pregnant women.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Healthy pregnant women aged 18 to 39 years, Healthy pregnant women with gestational age of 15-28 weeks (by LMP or ultrasound) which has health records at the center of health care, Life couples (couples living together during pregnancy). Exclusion criteria: High-risk pregnancies, such as vaginal bleeding, placenta Prvia, cervix incompetency, multiple pregnancies, pregnancy by assisted reproduction techniques, threatened abortion, chronic medical conditions (hypertension, diabetes, etc.), Recent or repeated abortions, Addiction in husband or wife, History of sexual dysfunction or untreated psychiatric disorder before pregnancy in couples, Bigamy, Drugs affect on sexual desire such as antidepressants
Age
From 18 years old to 39 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee Zahedan University of Medical Sciences
Street address
Pardis Zahedan University of Medical Science, Dr hesabi Sq
City
Zahedan
Postal code
9816743463
Approval date
2015-05-31, 1394/03/10
Ethics committee reference number
IR.ZAUMS.REC.1394.103
Health conditions studied
1
Description of health condition studied
Sex counselling in pregnancy
ICD-10 code
Z70.9
ICD-10 code description
Sex counselling , Unspecified
2
Description of health condition studied
sex counselling in pregnancy
ICD-10 code
Z70.8
ICD-10 code description
Other sex counselling
Primary outcomes
1
Description
Belief
Timepoint
Before the start intervention, Six weeks after finishing intervention
Method of measurement
Sexual Beliefs Questionnaire in pregnancy
2
Description
Attitude
Timepoint
Before the start intervention, Six weeks after finishing intervention
Method of measurement
Attitudes toward sexual activityQuestionnaire in pregnancy
Secondary outcomes
1
Description
Qualityof the marital relationship
Timepoint
Befor the start intervention, Six weeks of the finishing intervention
Method of measurement
Perceived Rlationship Quality Components
Intervention groups
1
Description
Intervention group will receive sexual counseling in 5 sessions of 90 minutes three times a week during two consecutive weeks .
Category
Lifestyle
2
Description
Control group will received only the centers routine care
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Musa bin Ja'far Health Center
Full name of responsible person
Parvin Soltani
Street address
Mostafa Khomeini 27 St, Zahedan
City
Zahedan
2
Recruitment center
Name of recruitment center
Emam Hadi Health Center
Full name of responsible person
Parvin Soltani
Street address
Ganbazan11 St, Ganbazan BLVD, Zahedan
City
Zahedan
3
Recruitment center
Name of recruitment center
Seyed Alshhda Health Center
Full name of responsible person
Parvin Soltani
Street address
Mir hosseini St, SHahid Ragai BLVD, Zahedan
City
Zaheadan
4
Recruitment center
Name of recruitment center
Emam hasan Mojtaba health Center
Full name of responsible person
Prvin Soltani
Street address
Jame jam 16 St, Jame jam BLVD, Zahedan
City
Zahedan
5
Recruitment center
Name of recruitment center
Valiasr Health Center
Full name of responsible person
Parvin Soltani
Street address
Mjdyh 23 St, Shir abad, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor research & Technology, Zahedan University of Medical Science
Full name of responsible person
Houshang Rafighdoost
Street address
Pardis Zahedan University of Medical Science, Dr Hessabi Sq
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor research & Technology, Zahedan University of Medical Science
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
Zahedan University of Medical Science
Full name of responsible person
Parvin Soltani
Position
Masters Student Midwifery Counseling
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Mashaheer Square
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
p_soltani@zaums.ac.ir, p_soltani.ac88@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Ali Navidian
Position
Associate Professor
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Mashaheer Square
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
Alinavidian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Parvin Soltani
Position
Masters Student Midwifery Counseling
Other areas of specialty/work
Street address
School Of Nursing & Midwifery , Mashaheer Square
City
Zahedan
Postal code
9816913396
Phone
+98 54 3344 2482
Fax
+98 54 3344 2481
Email
p_soltani@zaums.ac.ir, p_soltani.ac88@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)