Protocol summary

Study aim
Determining the effect of cognitive-behavioral group counseling on sexual assertiveness of pregnant women participating in childbirth preparation classes of midwifery counseling centers in Nahavand city in 2023
Design
A clinical trial with a control group, with parallel groups, randomized with statistical software, on 60 client
Settings and conduct
A number of pregnant women referred to midwifery consultation centers in Nahavand city were selected based on the conditions of entry into the study and after obtaining consent to participate in the study, they will be randomly divided into two intervention and control groups, and then a pre-test-post-test and follow-up experimental design will be used with the control group.
Participants/Inclusion and exclusion criteria
The inclusion criteria are being over 18 years old, being married, being pregnant, referring to midwifery consultation centers, agreeing to participate in the study, having no history of sexual disorders according to self-report and not facing severe crises and being available within the next two months. Exclusion criteria: high-risk pregnancy, severe marital conflicts according to self-report, history of mental illnesses as diagnosed by a psychiatrist, refusal to continue participating in the study, and incomplete answers to questionnaires.
Intervention groups
Counseling in the intervention group is held as a group and based on cognitive behavioral approach (CBT) weekly during 6 sessions of 45-90 minutes. In order to comply with ethical issues, after the completion of the research, an educational guide in the field of sexual assertiveness will be provided to the control group.
Main outcome variables
The effect of the independent variable (group counseling with a cognitive-behavioral approach) on the dependent variable (sexual assertiveness of pregnant women)

General information

Reason for update
Acronym
CBT
IRCT registration information
IRCT registration number: IRCT20231202060243N1
Registration date: 2024-06-22, 1403/04/02
Registration timing: retrospective

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Reihaneh Roozbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3323 0889
Email address
n_sh2029@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cognitive-Behavioral Group Counseling on Sexual Assertiveness of Pregnant Women
Public title
Investigating the Effect of Cognitive-Behavioral Group Counseling on Sexual Assertiveness of Pregnant Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be over 18 years old Be married Be pregnant Refer to midwifery consultation centers Consent to participate in the study Do not have a history of sexual disorders according to self-report Do not face severe crises such as the death of loved ones Be available in the next two months.
Exclusion criteria:
High risk pregnancy Severe marital conflicts according to self-report History of mental illnesses as diagnosed by a psychiatrist
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients was done by random allocation sampling in two stages.In this way, it was used to create a random sequence of two groups; in such a way that one of the study groups was considered to be lion and the other group was considered to be line and based on the desired sample size, a coin was tossed and people were divided into two random allocation groups. Sealed non-transparent envelopes were used to hide the random allocation.In this way, based on the sample size of the research, a number of envelopes with aluminum coating were prepared and each of the random sequences created was recorded on a card and the cards were placed in the letter envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes was numbered in the same order. Finally, the lid of the letter envelopes was glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes was opened and the assigned group of that participant was revealed.
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 Islamic Azad University - Isfahan branch(Khorasgan)
Street address
Memarian Alley, Shahid Heydari Blvd
City
Nahavand
Province
Hamadan
Postal code
6591936585
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.351

Health conditions studied

1

Description of health condition studied
It is not a disease.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual assertiveness score in Halbert questionnaire
Timepoint
Completing the Halbert questionnaire at the beginning of the study (before the start of the intervention) and 2 weeks later and then at the end of the study
Method of measurement
Hulbert Index of Sexual Assertiveness

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Counseling in the intervention group is held as a group and based on cognitive behavioral approach (CBT) weekly during 6 sessions of 45-90 minutes.The content of the meetings includes:The first session is the introduction and familiarization of the counselor and the clients with each other, explaining the details of the counseling session and familiarizing the clients with the cognitive-behavioral approach, and then the researcher started the discussion about sexual assertiveness by asking some open questions and allows the clients to speak and express their opinions.In the second session, conceptualization and description of the goals are done, and information related to anatomy, physiology, sexual cycle, etc. is provided to the clients.In the next sessions, therapeutic techniques and psychological training are used and CBT approaches are taught.The final session will focus on self-actualization.In the final sessions, there may be a need for the presence of the couple to continue care and counseling.
Category
Other

2

Description
Control group: This group will not receive any intervention.In order to comply with ethical issues, after the completion of the research, an educational guide in the field of sexual assertiveness will be provided to the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sogand midwifery counseling center
Full name of responsible person
Samira Roozbahani
Street address
17 Shahrivar St
City
Nahavand
Province
Hamadan
Postal code
0000000000
Phone
+98 81 3323 9910
Email
n_sh2029@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Mahsa Mousavi
Street address
Islamic Azad University of Isfahan (Khorasgan) Branch, Daneshgah Blvd, Arghavanieh Blvd, East Jey St
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Reihaneh Roozbahani
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Heidari Blvd
City
Nahavand
Province
Hamadan
Postal code
6591936585
Phone
+98 81 3323 0889
Fax
Email
n_sh2029@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reihaneh Roozbahani
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Heidari Blvd
City
Nahavand
Province
Hamadan
Postal code
6591936585
Phone
+98 81 3323 0889
Fax
Email
n_sh2029@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reihaneh Roozbahani
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Heidari Blvd
City
Nahavand
Province
Hamadan
Postal code
6591936585
Phone
+98 81 3323 0889
Fax
Email
n_sh2029@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
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
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