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The Effect of Group Sexual Health Counseling Based on Cognitive Behavioral Approach on the Dysfunctional Belief and Sexual Satisfaction of Women Primigravida

Protocol summary

Study aim
Investigation the effect of group counseling on sexual health based on cognitive-behavioral approach on ineffective beliefs and sexual satisfaction primigravida women
Design
Clinical Practice With Control Group
Settings and conduct
After obtaining permission from the Research and Technology Dept. and the Ethics Committee of the University, the women who were first eligible pregnant referred to two health centers in Isfahan, 52 were selected according to the criteria of entry and exit of the study and then randomly assigned to two groups Equal to intervention and control. After getting informed consent, sexual satisfaction and sexual misconduct questionnaires are completed by the subjects, and then eight 90-minute weekly counseling sessions are held immediately after the completion and one month after The completion of the questionnaires was completed again and the results were analyzed statistically Will.
Participants/Inclusion and exclusion criteria
First pregnancy, weeks 6 to 24, having primary education, passing one year of marital life, having a pregnancy, having no medical and mental illness, no drug use, having no sexual dysfunction in yourself and a pregnant wife, a common life of permanent monogamy, Lack of acute mental illness and non-addiction and wife to drug and alcohol , the lack of use of drugs, no problems during the study , abnormal fetal heart patterns Or reduced fetal movements and the absence of medical conditions or drugs that may affect the libido. .
Intervention groups
Intervention and control group 52 Primigravid women 6 to 24 weeks. For intervention group 8 sessions group counseling with a cognitive behavioral approach will be conducted once a week and will not be conducted for interventional control group.
Main outcome variables
Ineffective sexual beliefs and sexual satisfaction

General information

Reason for update
Acronym
Cognitive-Behavioral Therapy .CBT
IRCT registration information
IRCT registration number: IRCT20181207041875N1
Registration date: 2019-05-30, 1398/03/09
Registration timing: retrospective

Last update: 2019-05-30, 1398/03/09
Update count: 0
Registration date
2019-05-30, 1398/03/09
Registrant information
Name
Marzieh Zareigashiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3263 0018
Email address
m.zarei@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-01, 1397/09/10
Expected recruitment end date
2019-03-30, 1398/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Sexual Health Counseling Based on Cognitive Behavioral Approach on the Dysfunctional Belief and Sexual Satisfaction of Women Primigravida
Public title
The Effect of Group Sexual Health Counseling Based on Cognitive Behavioral Approach on the Dysfunctional Belief and Sexual Satisfaction of Women Primigravida
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy Gestational age 6 to 24 weeks Reading and writing literacy At least one year of marital life The desire for pregnancy The absence of medical and psychological illness, lack of medication lack of sexual dysfunction in themselves and the spouse before pregnancy The common life of a single monogamous person His lack of addiction and his wife to drugs and alcoholic beverages (according to Fred) lack of mental and psychological illnesses and spouses Non-use of psychosocial drugs (tricyclic antidepressants, inhibition Open serotonin absorption and ...)
Exclusion criteria:
The incidence of any pregnancy problem during the study (Abortion, Decollete, Abnormal Embryo, Cord Prolapse, Blood, Diabetes, Hypertension, Preterm Delivery, etc) Abnormal fetal heart patterns, or reduced fetal movements in a way that requires medical intervention. The advent of medical conditions or medications that may affect sexual function during an intervention Incineration criteria included
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of this study is simple randomization. Among the primigravida women referred to clinics of Isfahan, 52 people are eligible to enter the inclusion criteria and will be assigned to each person by using the table of pictures to be divided into two groups of intervention and control.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
End of Yas, Hariri Alley, Motahari Ave.
City
Yazd
Province
Yazd
Postal code
8917698148
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.SSU.REC.1397.112

Health conditions studied

1

Description of health condition studied
dysfunctional belief and sexual satisfaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score of noneffective beliefs sexual
Timepoint
Measurement of sexual beliefs score before, after and one month after the completion of counseling
Method of measurement
noneffective beliefs questionnaire

2

Description
The score of sexual satisfaction
Timepoint
Measurement of sexual satisfaction score before, after and one month after the completion of counseling
Method of measurement
Sexual satisfaction Questionnaire Larson sexual

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For routine care intervention group and 8 sessions of 90 minutes, group counseling with cognitive behavioral approach is held once a week.
Category
Behavior

2

Description
Control group: Only routine pregnancy is done.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Isfahan province
Full name of responsible person
Marzieh Zarei Gashiri
Street address
no.59 , alley shahid mahmmod zarei , Ave sarvestan, Ave moshtagh dovom
City
Esfahan
Province
Isfehan
Postal code
8158168688
Phone
+98 31 3263 0018
Email
zarei.marzi1512@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Faculty of midwifery nursery Bu,Ali Alley, Thimsar Fallahi Street, Safeie, Yazd
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1751
Email
M.zarei1512@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Marzieh Zarei Gashiri
Position
Master,s degree in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of midwifery nursery Bu,Ali Alley, Thimsar Fallahi Street, Safeie, Yazd
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1751
Email
M.zarei@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.mahshid bokaie
Position
PhD in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of midwifery nursery Bu,Ali Alley, Thimsar Fallahi Street, Safeie, Yazd
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1757
Email
mah_bokaie@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Marzih zarei gashiri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of midwifery nursery Bu,Ali Alley, Thimsar Fallahi Street, Safeie, Yazd
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3824 1757
Email
Zarei.marzi1512@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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
No - There is not a plan to make this available
Title and more details about the data/document
The results of the clinical study will be published as a paper
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Email:m.zarei@ssu.ac.ir
What processes are involved for a request to access data/document
Up to one week after correspondence by email
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