Determining the effectiveness of counseling based on acceptance and commitment on sexual self-confidence of pregnant women
Design
The clinical trial has a control and intervention group، with parallel groups، blinding in such a way that the information analyst is unaware of the group of people and the participants are aware of their group، randomized in a block method، allocated to the volume of 4 sequences، on 70 patients and Spss will be used for analysis.
Settings and conduct
It will be done in the health centers of Isfahan and the data analyst is unaware of the group of people. In the intervention group، 4 midwifery counseling sessions with the approach of acceptance and commitment in the sexual self confidence of pregnant women are held، and in the control group، routine pregnancy care is provided. Participation in the study will be held.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-35، married، Pregnancy 18-28 weeks، Iranian nationality، living in Isfahan city، Having at least reading and writing literacy، Consent to participate in the study.
Exclusion criteria: A history of hospitalization in the psychiatric department and suffering from mental disorders، having a mental disability، having a physical disability and disability، having an underlying disease، having sexual dysfunction، having a high-risk pregnancy، having a stressful event in the last 6 months، Having a sexual performance score below 15 in the sexual performance questionnaire.
Intervention groups
In the intervention group، 4 midwifery counseling sessions with the approach of acceptance and commitment in the sexual self-confidence of pregnant women are held، and in the control group، routine pregnancy care is provided. Participation in the study will be held.
Main outcome variables
Sexual self-confidence level of pregnant women.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230909059386N1
Registration date:2023-11-16, 1402/08/25
Registration timing:prospective
Last update:2023-11-16, 1402/08/25
Update count:0
Registration date
2023-11-16, 1402/08/25
Registrant information
Name
Fatemeh Yousefian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 0084
Email address
fatemehysf1376@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of counseling based on the acceptance and commitment on sexual self-esteem pregnant women.
Public title
Effect of counseling based on the acceptance and commitment on sexual self-esteem pregnant women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-35
Married
Pregnancy 18-28 weeks
Iranian nationality
Living in Isfahan city
Having at least reading and writing literacy
Consent to participate in the study
Exclusion criteria:
A history of hospitalization in the psychiatric department and suffering from mental disorders
Having a physical disability and disability
Having a mental disability
Having an underlying disease
Having sexual dysfunction
Having a high-risk pregnancy
Having a stressful event in the last 6 months
Having a sexual performance score below 15 in the sexual performance questionnaire
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:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted Block randomization.
Blocking is usually used in order to balance the number of samples allocated to each of the studied groups. This feature helps the researchers so that the number of samples allocated to each of the studied groups is equal in cases where intermediate analyzes are needed during the sampling process. The size of all the blocks is equal and we will use 4 blocks in this experiment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The data analyst is blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahrod University of Medical Sciences
Street address
Research and Technology Vice Chancellor, Shahrood University of Medical Sciences and Health Services,7 Tir Square
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۳
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.SHMU.REC.1402.122
Health conditions studied
1
Description of health condition studied
Sexual confidence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual self-confidence level of pregnant women
Timepoint
Before the intervention; in the last intervention session; one month after the last session
Method of measurement
The questionnaire of this study is the Women's Sexual Self-Esteem Questionnaire-Short Form (SSEI-W-SF).
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, we will have 4 sessions of 90 minutes in 4 weeks with a counseling approach based on acceptance and commitment.
Category
Lifestyle
2
Description
Control group: routine prenatal care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhangian health center
Full name of responsible person
Dr shamsolsadat izadi
Street address
Bagh ziyar street
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3776 9646
Email
Dr_shamsolsadat_izadi@gmail.com
2
Recruitment center
Name of recruitment center
Shahid fadayi health center
Full name of responsible person
Dr farshad amiri
Street address
Hakim nezami three way
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3628 9009
Email
Farshad_amiri@yahoo.com
3
Recruitment center
Name of recruitment center
Sodan health center
Full name of responsible person
Dr samane landaran
Street address
Samadiye street
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3738 9999
Email
Landaran_samane@gmail.com
4
Recruitment center
Name of recruitment center
Dastgerd health center
Full name of responsible person
Dr behzad laghavi
Street address
Ghaemiye Street
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3780 8575
Email
Laghavi.behzad@yahoo.com
5
Recruitment center
Name of recruitment center
Maleksgahr health center
Full name of responsible person
Dr baghei
Street address
Malekshahr Street
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3626 1484
Email
Dr_bagheri@gmail.com
6
Recruitment center
Name of recruitment center
Gole yas health center
Full name of responsible person
Dr samane landari
Street address
Atishgah street
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3771 8170
Email
Landari_samabe@gmail.com
7
Recruitment center
Name of recruitment center
Amirhamze health center
Full name of responsible person
Dr fateme moradpor
Street address
Koye amiriye street
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3668 7303
Email
Moradpor246_fateme@gmail.com
8
Recruitment center
Name of recruitment center
Vahid health center
Full name of responsible person
Dr shahnaz fesharaki
Street address
Vahid street
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3228 1121
Email
Fesharaki_shahnaz12@gmail.com
9
Recruitment center
Name of recruitment center
Sepahanshahr health center
Full name of responsible person
Dr faramarz emamdost
Street address
Ghadir Street
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3669 8066
Email
Dr_emamdost@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr mohamadhasan emamian
Street address
7 tir Square
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۳
Phone
+98 23 3239 5054
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
Fatemeh yousefian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jahangiri dead end، simin's three ways
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3775 0084
Email
Fatemehysf1376@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh yousefian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jahangiri dead end، simin's three ways.
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3775 0084
Email
Fatemehysf1376@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fatemeh yousefian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Jahangiri dead end، simin's three ways.
City
Isfahan
Province
Isfehan
Postal code
8174744383
Phone
+98 31 3775 0084
Email
Fatemehysf1376@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available