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Effect of BETTER model Sexual Counseling on sexual Quality of Life and Depression in pregnancy

Protocol summary

Study aim
1.Effect of BETTER model Sexual Counseling Depression in Pregnancy 2.Effect of BETTER model Sexual Counseling on sexual Quality of Life and Depression in Pregnancy
Design
This study was a randomized clinical trial that has an intervention group and a control group.Webber is performed on 64 patients by randomization of random block sequencing website
Settings and conduct
Counselling sessions are carried out in a comprehensive health base of the city. People enter the research community, which is the score of depression under 12, is completed for both groups. The intervention is carried out on two sessions of sexual counseling, 45 minutes, which is determined by the mother of the sessions, the control group will only receive routine care in the intervention group.The outcomes of the study were assessed by questionnaires a month later
Participants/Inclusion and exclusion criteria
tend to participate in research, age range between 18-35 years having minimal literacy of reading and writing of drug or alcohol failure to have chronic and psychological diseases during pregnancy and before pregnancy and having no history of abortion or infant death of pregnancy is not a history of infertility Or pregnancy, with the help of fertility,
Intervention groups
the research community of the intervention in the form of two 45-minute sexual counseling sessions, which is the interval of sessions by mother and within 14th25weeks, based on the BETTER model in the intervention group.The control group will only receive routine care
Main outcome variables
Quality of sexual life is measured by the quality of Sexual Life questionnaire (SQOL-F). SQOL-F is a tools that linking in the form of sexual function and quality of life of women. Depression, this consequence is assessed by Edinburgh questionnaire. The aim of this study was to assess postpartum depression and pregnancy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200516047467N1
Registration date: 2020-06-11, 1399/03/22
Registration timing: registered_while_recruiting

Last update: 2020-06-11, 1399/03/22
Update count: 0
Registration date
2020-06-11, 1399/03/22
Registrant information
Name
Maral Forqani far
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3282 2262
Email address
maralforqanifar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of BETTER model Sexual Counseling on sexual Quality of Life and Depression in pregnancy
Public title
effect of sexual counseling on the sexual quality of life and depression in pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy required in the second trimester of pregnancy (15 weeks to 25 weeks Age 18-35 years Have a minimum of literacy Do not use drugs or alcohol Have no chronic mental illness before and during pregnancy No history of miscarriage or infant death Single infant No history of infertility or pregnancy with assisted reproductive techniques(ART) There are no pregnancy problems such as prolactinemia or fetal problems such as weight loss dont have Sexual disease before and now Depression scores below 12 with EPDS
Exclusion criteria:
Have diabetes Take drugs that affect the sexual cycle Marital disputes or abstinence from partner for any reason
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method, which is one of the following limited randomization groups, is used. 4-block method is used to create a random allocation sequence in this study. Pregnant women will be selected according to the criteria of the researcher and are randomly assigned to the central Randomization method in two groups (intervention) and B (control).In order to perform this task, the sequencing website will be created by random blocks.In this study, by using the software, by the methodology consultant, the random allocation sequence is obtained., in this study, the random sequence of blocks will be provided to the specific of the research team, which is responsible for the random allocation.With the arrival of mothers to study and register them at any centre, at the same time, all persons and their conditions will be recorded in a central list, and they will receive a code in order to log in.Then it is responsible for the allocation of codes to receive and assign people to intervention and control groups.Mhaghqbrasas the entry of participants to study with the relevant center and questions about the random allocation of the participant to the study group.Communication methods include using your phone, message, fax, email, etc
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
7 tir str uni shmu
City
Shahroud
Province
Semnan
Postal code
7575135534
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.SHMU.REC.1399.043

Health conditions studied

1

Description of health condition studied
depression during pregnancy
ICD-10 code
F33.1
ICD-10 code description
Major depressive disorder, recurrent, moderate

Primary outcomes

1

Description
sexual quality of life
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Sexual quality of life questionnaire is a means that the linking of the quality of sexual function, women in the life of females.It is a report that focuses on the confidence of the relationship between women, emotional and communicative beliefs

2

Description
depression
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Edinburgh Depression Questionnaire is used to measure depression during pregnancy and postpartum period

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the case of two weeks, a 45-minute sex consultation with a one-week interval is performed individually for mothers 14-25 weeks pregnant in the intervention group.Each session is based on this model including 6 steps: 1-bieng-2-explain about whether sexual relationship is part of quality of life-3-tell a bout their concerns in the future-4-time of intervention-5-education-6-Record of interventions
Category
Behavior

2

Description
Control group: recieves routine care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahmaee Helth Center
Full name of responsible person
Maral Forqanifar
Street address
Qods St,Bahmaee Helth Center
City
lilak
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7575154459
Phone
+98 74 3282 2262
Email
Maria22121372@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
Seven Tir St,Shahroud Univesity of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5014
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
Maral Forqani far
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rahbari st,saadi
City
Likak
Province
Kohgilouyeh-va-Boyrahmad
Postal code
757554459
Phone
+98 74 3282 2262
Fax
Email
Maralforqanifar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maral Forqani far
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rahbari st,saadi
City
Likak
Province
Kohgilouyeh-va-Boyrahmad
Postal code
757554459
Phone
+98 74 3282 2262
Fax
Email
maralforqanifar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maral Forqani far
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rahbari st,saadi
City
Likak
Province
Kohgilouyeh-va-Boyrahmad
Postal code
757554459
Phone
+98 74 3282 2262
Fax
Email
maralforqanifar@gmail.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
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
The entire potential data is unidentifiable after being detected by peopl
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Those who are allowed to submit an application for personally identifiable information with other documents
From where data/document is obtainable
Shahroud University of Medical Sciences maral forqani far
What processes are involved for a request to access data/document
6months of Waiting
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