Protocol summary

Study aim
Determining the effect of Cognitive Behavioral Counseling on Self efficacy and Sexual attitudes in Newly married women
Design
A counseling intervention study with a control group, with a total of 82 participants who will be divided into two groups of 41 participants. Participants will be divided into two intervention and control groups using random blocks. Randomization codes will be generated using computer randomization software.
Settings and conduct
The study will be conducted at the Premarital Counseling Center in Azadshahr, Golestan Province; Couples who previously visited the center and meet the inclusion criteria will be invited to participate. Participants will complete the questionnaires; then the intervention group will receive 8 weekly 90-minute Cognitive Behavioral Counseling sessions.The control group will not receive any intervention. Two and eight weeks after the completion of the counseling sessions, both groups will refill the questionnaires, and the results will be analyzed.
Participants/Inclusion and exclusion criteria
Newly married women (1 to 3 Years)؛ A score below the overall average (below 1850) on the Beals Women's Sexual Self efficacy Scale؛ First marriage and living in a common home؛ Literate؛ Do not apply for divorce or separation؛ Not having a physical or mental disability؛ Marriage is not compulsory؛ Neither partner is addicted to drugs؛ Absence of malignant and incurable diseases
Intervention groups
The intervention group will receive 8 90-minute sessions of Cognitive Behavioral Counseling on Self efficacy and Sexual attitudes, once a week. The control group will not receive any intervention. At the end of the study, one counseling session will be held for the control group.
Main outcome variables
Sexual self efficacy and sexual attitudes will be measured using the Bills Sexual Self efficacy Questionnaire and the Hudson Sexual Attitude Questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260225068944N1
Registration date: 2026-03-01, 1404/12/10
Registration timing: prospective

Last update: 2026-03-01, 1404/12/10
Update count: 0
Registration date
2026-03-01, 1404/12/10
Registrant information
Name
Fatemeh Norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3573 9789
Email address
norouzi.f1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-07, 1404/12/16
Expected recruitment end date
2026-05-21, 1405/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Cognitive Behavioral Counseling on Self efficacy and Sexual attitude in Newly Married Women
Public title
Investigating the Effect of Cognitive Behavioral Counseling on Self efficacy and Sexual attitude
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Newly Married Women (1 to 3 Years have Passed Since their Marriage) Have Scored Below the Overall Average (Subscore 1850) on the Beals Women's Sexual Self efficacy Scale First Marriage and Living in a Common home (Permanent Marriage) Be Literate in Reading and Writing Do not Apply for Divorce or Separation Not having a Physical or Mental Disability Marriage Is not Compulsory Neither Partner is Addicted to Drugs Absence of Malignant and Incurable Diseases
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be Divided into Two Groups, Intervention and Control, Using Random Blocks A and B (A Intervention Group; B Control Group). Randomization Codes will be Generated Using Computer Randomization Software, and the Size of the Random Blocks will be 4 in 6 Cases With 1:1 Allocation. Opaque and Sealed Envelopes will be Used to Conceal Allocation, and the Envelopes will be Revealed Sequentially When Participants Enter the Study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In the Grouping Method, Participants will be Divided into Two Intervention and Control Groups Using Random Blocks A and B (A Intervention Group; B Control Group). In the Intervention Group, 8 90-Minute Sessions of Cognitive Behavioral Counseling on Sexual Self efficacy and Sexual attitudes will be Conducted Once a Week.The Control Group Will not Receive any Intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak County, Arak University of Medical Sciences, Payambar Azam (PBUH) University Complex, Deputy of Research and Technology
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2025-10-19, 1404/07/27
Ethics committee reference number
IR.ARAKMU.REC.1404.276

Health conditions studied

1

Description of health condition studied
Investigating the impact of cognitive behavioral counseling on self efficacy and sexual attitude in newly married women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Sexual self efficacy, The score of which is determined based on the Women’s Sexual Self efficacy Questionnaire developed by Bills and colleagues.
Timepoint
At the beginning of the study (before the intervention starts), and 2 and 8 weeks after the end of the counseling sessions
Method of measurement
The Women’s Sexual Self efficacy Questionnaire by Bills and colleagues

2

Description
The sexual attitude score, which is determined based on the Sexual Attitude Questionnaire designed by Hudson and colleagues.
Timepoint
At the beginning of the study (before the intervention starts), and 2 and 8 weeks after the end of the counseling sessions
Method of measurement
The Sexual Attitude Questionnaire by Hudson and colleagues

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The intervention group will receive 8 90-minute sessions of Cognitive Behavioral Counseling on Sexual self efficacy and Sexual attitudes, one session per week based on the book Cognitive Behavioral Therapy: Basics and Beyond by Judith S. Beck, and obtaining relevant valid certificates by a master's student in midwifery counseling under the supervision of a consultant professor.
Category
N/A

2

Description
Control group: The control group will not receive any intervention, and at the end of the study, a counseling session will be held for the control group to comply with ethical principles.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Community Health Center No. 2 - Marriage Counseling Unit
Full name of responsible person
Fatemeh Norouzi
Street address
Gorgan Street, Shahid Beheshti Street
City
Azadshahr
Province
Golestan
Postal code
4961679631
Phone
+98 17 3577 6057
Email
norouzi.f1998@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
Arak County, Arak University of Medical Sciences, Payambar Azam (PBUH) University Complex, Deputy of Research and Technology.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Norouzi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood Street, Raja 24
City
Azadshahr
Province
Golestan
Postal code
4961679631
Phone
+98 17 3573 9789
Fax
Email
norouzi.f1998@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Norouzi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood Street , Raja 24
City
Azadshahr
Province
Golestan
Postal code
4961679631
Phone
+98 17 3573 9789
Fax
Email
norouzi.f1998@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Norouzi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood Street, Raja 24
City
Azadshahr
Province
Golestan
Postal code
4961679631
Phone
+98 17 3573 9789
Fax
Email
norouzi.f1998@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
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