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Investigation of the effect of education on modifying dysfunctional sexual beliefs of pregnant women by using Text Message

Protocol summary

Study aim
(GENERAL OBJECTIVES): Determining the effect of sexual education by sending text message on modifying dysfunctional sexual beliefs in pregnant women (SPECIFIC OBJECTIVES): 1-Determination and comparison of the mean of dysfunctional sexual beliefs score in pregnant women, before and after education in the intervention group 2-Determination and comparison of the mean of dysfunctional sexual beliefs score in pregnant women, before and after education in the control group 3-Determination and comparison of the mean of dysfunctional sexual beliefs score in pregnant women, before and after education in 2 groups of intervention and control
Design
Randomized, controlled clinical trial, in parallel with a control group
Settings and conduct
This study was performed on 82 pregnant women who referred to Prenatal Care Center (Emam Ali and Kamali Hospital).Samples are randomly distributed from each center(40 people per center) based on entrance criteria and randomly assigned to each intervention and control group.
Participants/Inclusion and exclusion criteria
18-45 years age of healthy pregnant women, with gestational age of 14-28 weeks, married with monogamous life, Iranian nationality, speaking Persian, having minimum ability of reading and writing, having personal cellphone, not having abortion and Marital incompatibility history, having dysfunctional sexual beliefs according to the questionnaire
Intervention groups
Intervention group: 41 Pregnant women will be placed in the intervention group according with the entry criteria and in 8 weeks such every other day on specified hour, totally 24 sexual text messages will be sent for them. Data will be collected before and immediately after the intervention by Demographic characteristics, Marital compatibility questionnaire and dysfunctional sexual beliefs questionnaire.
Main outcome variables
dysfunctional sexual beliefs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161230031662N9
Registration date: 2019-07-15, 1398/04/24
Registration timing: registered_while_recruiting

Last update: 2019-07-15, 1398/04/24
Update count: 0
Registration date
2019-07-15, 1398/04/24
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of education on modifying dysfunctional sexual beliefs of pregnant women by using Text Message
Public title
The effect of education on modifying dysfunctional sexual beliefs of pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of pregnant women : between 18-45 years Gestational age :14-28 weeks (Based on LMP or Sonography) with Prenatal Care sheet Having ability to read and write Wanted pregnancy No use of Drugs Affecting Sexual Function Physical Health of the Mother Married monogamous life Having personal Cellphone Iranian nationality Fluency in Persian
Exclusion criteria:
Known Psychiatric diseases Having history of sexual dysfunction or any untreated Psychiatric disorder before pregnancy in married couples Using psychiatric drugs such as: Anti-Depression drug Addiction of husband or wife High-risk pregnancy such as: Vaginal bleeding, Placenta Previa, Cervix Insufficiency, Cervical Cerclage, Twinings, Fertility by ART, Threat to abortion, Chronic medical diseases(Diabetes, Blood Hypertension, Cardiovascular disease and...) Previous abortion history Having Marital incompatibility Announcing opt-out from continuing the study
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: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization Individual randomization Online randomization Allocation concealment: Using opaque envelopes
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 Alborz University of Medical Sciences
Street address
North Taleghani , Azimiyeh
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.ABZUMS.REC.1398.024

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
Z70.0
ICD-10 code description
Counseling related to sexual attitude

Primary outcomes

1

Description
ِِِDysfunctional sexual beliefs
Timepoint
Before intervention, Immediately after intervention
Method of measurement
ِِِDysfunctional Sexual Beliefs Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 41 pregnant women will receive sexual educational text messages three times a week(every other day) totally 24 SMS.
Category
Prevention

2

Description
Control group: 41 pregnant women just receive routine prenatal care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali teaching hospital
Full name of responsible person
Shirin Khoddam
Street address
Emam Ali medical-educational center-Azimieh Junc, First of the Chalus Road
City
Karaj
Province
Alborz
Postal code
3155683119
Phone
+98 26 3250 0123
Fax
+98 26 3254 7128
Email
EMAMALI@abzums.ac.ir
Web page address
https://emamali.abzums.ac.ir

2

Recruitment center
Name of recruitment center
Kamali teaching hospital
Full name of responsible person
Shirin Khoddam
Street address
Kamali Hospital, Kamali Street, Taleghani Street, Shohada Square
City
Karaj
Province
Alborz
Postal code
3134877179
Phone
+98 26 3222 2021
Email
Hospital.Kamali@Abzums.ac.ir
Web page address
https://kamali.abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
North Taleghani street, Azimiyeh
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 4255
Email
dr.noorisepehr@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Alborz 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
Karaj University of Medical Sciences
Full name of responsible person
Shirin Khoddam
Position
BsC in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nabovvat Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7685
Email
shirinkhoddam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
1st Golestan Street, South Eshteraki Boulevard, Baghestan
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 912 765 5855
Email
lotfi_razieh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Shirin Khoddam
Position
BCs in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Medicine, University of Medical Sciences Campus, University of Art, End of West Bou Ali Street, Nabovvat Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7685
Email
shirinkhoddam@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total potential data can be shared after unidentifiable people
When the data will become available and for how long
Data will be in access 6 months after publishing the results.
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Scientific studies
From where data/document is obtainable
Using Email Address:marmarmzf@gmail.com
What processes are involved for a request to access data/document
Up to a week after sending the email address
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