Evaluation of midwifery counseling's effectiveness on amendment of dysfunctional sexual beliefs of pregnant, and improvement of sexual life's quality and sexual competence in pregnant women through cognitive-behavioral aspects.
Evaluation of midwifery counseling's effectiveness on amendment of dysfunctional sexual beliefs, and improvement of sexual life quality and sexual competence in pregnant women through cognitive-behavioral aspects.
Design
This case-control trial study was conducted with method of parallel group randomization on 45 pregnant women.
Settings and conduct
A total of 94 pregnant women who met the inclusion criteria were collected from the health centers of Rey city and then they will be randomly divided into two group of intervention and control. Subsequent to interventions, the level of dysfunctional sexual beliefs, sexual competence, and then quality of sexual life in pregnant women will be collected using a standard questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with gestational age of 15 to 28 weeks, women without serious physical and psychological illness, women with literacy of at least writing and reading, wanted pregnancy, women with moderate to high scores of dysfunctional sexual beliefs, and don't taking medicine (other than pregnancy supplements)
Exclusion criteria: participants with pregnancy complications, history of alcohol usage and smoking, and use of medications affecting sexual desire including anti-depressants and anti-hypertensive drugs.
Intervention groups
Intervention group: patients who completed a questionnaire and attended in 4-session long program of cognitive-behavioral counseling (a 90-minute session weekly)
Control group: women who completed a questionnaire and received routine pregnancy care.
Main outcome variables
Dysfunctional sexual beliefs; sexual competence; quality of sexual life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210221050439N1
Registration date:2021-07-11, 1400/04/20
Registration timing:retrospective
Last update:2021-07-11, 1400/04/20
Update count:0
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
Masoumeh Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3612 5532
Email address
rezayim3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of midwifery counseling's effectiveness on amendment of dysfunctional sexual beliefs of pregnant, and improvement of sexual life's quality and sexual competence in pregnant women through cognitive-behavioral aspects.
Public title
The effect of dysfunctional sexual beliefs on quality and sexual competence of pregnant women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
absence of serious physical and psychological diseases
wanted pregnancy (planned pregnancy)
literacy of at least reading and writing
having average-to-high score of dysfunctional sexual belief
absence of medication use (pregnancy supplements are exempted)
gestational age of 15-28 weeks at the time of study
Exclusion criteria:
presence of pregnancy complications such as miscarriage
history of cervical cerclage
presence of gestational hypertension
presence of placenta previa, the possibility of preterm delivery in the current pregnancy
history of alcohol consumption and smoking
consumption of medications influencing sexual desire including antidepressants and antihypertensive drugs
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
We used quadruple block method and these blocks were randomly designed in Excel software then Equivalent groups were assigned: A to the intervention group and B to the control group.
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, 7th of Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73947
Approval date
2021-04-11, 1400/01/22
Ethics committee reference number
IR.SHMU.REC.1400.009
Health conditions studied
1
Description of health condition studied
Correction of dysfunctional sexual beliefs of pregnant women
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Improving the quality of sexual life and sexual function of pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dysfunctional sexual beliefs in pregnancy
Timepoint
Before and after the intervention and 4 weeks after the intervention
Method of measurement
Questionnaire on dysfunctional sexual beliefs in pregnancy
Secondary outcomes
1
Description
Quality of sexual life
Timepoint
Before and after the intervention and 4 weeks after the intervention
Method of measurement
Simond Women's Quality of Sexual Quality Questionnaire
2
Description
Sexual function
Timepoint
Before and after the intervention and 4 weeks after the intervention
Method of measurement
Rosen Women Sexual Function Questionnaire
Intervention groups
1
Description
Intervention group includes 47 pregnant women who will fill out standard questionnaires regarding dysfunctional sexual beliefs, sexual function and quality of sexual life twice, once before and once after the intervention. The intervention is composed of 4 sessions of cognitive-behavioral counseling for 90 minutes each week. The syllabi of this counseling course are as follow: cognitive triad (1st session), ABC model of cognitive behavioral therapy (2nd session), problem-solving skills (3rd session), and coping strategies for dysfunctional sexual beliefs (4th session).
Category
N/A
2
Description
Control group: No intervention is performed in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rey City Health Center
Full name of responsible person
Masomeh Rezaei
Street address
Shahid Ghazizadeh St., Kianshahr
City
Rey City
Province
Tehran
Postal code
1851716379
Phone
+98 21 3388 7275
Fax
+98 21 3388 4398
Email
rezayim3@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohamad Hasan Emamian
Street address
Shahroud University of Medical Sciences, 7th of Tir Square
City
Shahroud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Masomeh Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 27, Mahdieh III, Mohammadabad
City
Garchak
Province
Tehran
Postal code
1868968519
Phone
+98 21 8670 5503
Email
Rezayim3@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masomeh Rezaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 27, Mahdieh III, Mohammadabad
City
Garchak
Province
Tehran
Postal code
1868968519
Phone
+98 21 25532
Email
Rezayim3@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masomeh Rezaei
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 27, Mahdieh III, Mohammadabad
City
Garchak
Province
Tehran
Postal code
1868968519
Phone
+98 21 25532
Email
Rezayim3@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data obtained from this project will eventually be reported generally and personal information of individuals will remain confidential.
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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information and information about the main outcome of this project can be shared.
When the data will become available and for how long
The data become accessible a year after publishing of the results.
To whom data/document is available
The data of this project can be shared by all aspiring and working researchers in academic and scientific institutes.
Under which criteria data/document could be used
After suitable citation, the use of the data is unrestricted to improve the quality of similar studies .
From where data/document is obtainable
The data of the present research can be requested through writing an email to Rezayim3@gmail.com
What processes are involved for a request to access data/document
After confirming the eligibility of the person requesting the information, the data will be sent as soon as possible.