Comparison of the effectiveness of the integrative cognitive-behavioral art therapy approach and the cognitive-behavioral approach versus control group on sexual anxiety, sexual self-efficacy, and sexual quality-of-life in newly married women: a randomized clinical trial
To compare the effectiveness of the integrative cognitive-behavioral art therapy approach and the cognitive-behavioral approach versus control group on sexual anxiety, sexual self-efficacy, and sexual quality of life in newly married women
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 36 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Urmia Consulting Center before Marriage, involving 36 eligible newly married women. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will not be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 14 to 45 years,
First marriage,
Educated,
Exclusion criteria:
Psychiatric disorders
Intervention groups
Intervention group 1:
Routine education and care of the newly married couples plus integrative cognitive-behavioral art therapy approach for 90 minutes, one session per week for 7 weeks
Intervention group 2:
Routine education and care of the newly married couples plus cognitive-behavioral approach for 90 minutes, one session per week for 6 weeks
Control group:
Routine education and care of the newly married couples
Main outcome variables
Primary outcome:
Average sexual anxiety score; Average sexual self-efficacy score; Average quality of sextual life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N599
Registration date:2026-04-08, 1405/01/19
Registration timing:prospective
Last update:2026-04-08, 1405/01/19
Update count:0
Registration date
2026-04-08, 1405/01/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-05, 1405/02/15
Expected recruitment end date
2026-06-05, 1405/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of the integrative cognitive-behavioral art therapy approach and the cognitive-behavioral approach versus control group on sexual anxiety, sexual self-efficacy, and sexual quality-of-life in newly married women: a randomized clinical trial
Public title
Comparison of the effectiveness of the integrative cognitive-behavioral art therapy approach and the cognitive-behavioral approach versus control group on sexual anxiety, sexual self-efficacy, and sexual quality-of-life in newly married women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 14 to 45 years,
First marriage,
Educated,
Exclusion criteria:
Psychiatric disorders
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:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be performed using block randomization. To achieve this, six sheets of paper will be prepared - two with the name of "Intervention 1," two with the name of "Intervention 2," and two with the name of "Control." These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Urmia University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Urmia University of Medical Sciences, Pardis Nazlo Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2026-02-18, 1404/11/29
Ethics committee reference number
IR.UMSU.REC.1404.521
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Average sexual anxiety score
Timepoint
Before intervention and 7 weeks later
Method of measurement
Using the sexual anxiety questionnaire
2
Description
Average sexual self-efficacy score
Timepoint
Before intervention and 7 weeks later
Method of measurement
Using the sexual self-efficacy questionnaire
3
Description
Average quality of sextual life score
Timepoint
Before intervention and 7 weeks later
Method of measurement
Using the sextual quality-of-life questionnaire for women
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Routine education and care of the newly married couples plus integrative cognitive-behavioral art therapy approach for 90 minutes, one session per week for 7 weeks (including: designing a sensation map of the body with anxiety concept using water paint, designing negative thoughts, mapping a face presenting negative believes and writing negative words and placing them around the picture using color pencil, painting with closed ees, painting with freely movement of the hands, writing a letter to yourself about needs, desire, and emotion in respect to sextual relationship)
Category
Treatment - Other
2
Description
Intervention group 2: Routine education and care of the newly married couples plus cognitive-behavioral approach for 90 minutes, one session per week for 6 weeks (including: definition of concept of sextual anxiety, training technique of relaxation, detecting anxiety situation and ranking them and training who the deal with them, realizing the strengthening factors of sextual self-confidence, training how the talk and expressing emotion to your husband, training effective relationship about sextual needs and desire, identifying ways of increasing pleasure and intimacy)
Category
Treatment - Other
3
Description
Control group: Routine education and care of the newly married couples
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Consulting Center before Marriage
Full name of responsible person
Hasti Jafari
Street address
Urmia Consulting Center before Marriage, Hasani Ave.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3346 5079
Email
jafarihasti2001@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Saber Gholizadeh
Street address
Urmia University of Medical Sciences, Pardis Nazlo Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
info.research@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Hasti Jafari
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Pardis Nazlo Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
jafarihasti2001@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. Soheila Rabieipoor
Position
Reproductive Health Specialist
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Urmia University of Medical Sciences, Pardis Nazlo Road
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Soheila80@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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