Comparing the effect of cognitive-behavioral therapy and education based on sexual health self care needs on sexual assertiveness and satisfaction in recently married women: a randomized clinical trial
Determining the effect of cognitive behavior therapy (CBT) and education based on sexual health self-care needs on sexual assertiveness and satisfaction of newly married women
Design
A randomized controlled clinical trial with three parallel groups, non-blind will be conducted on 66 recently married women. The participants will be assigned into three groups by blocked randomization using RAS with block sizes of 9, 6 and the allocation ratio of 1:1:1.
Settings and conduct
Sampling will be performed on newly married women who had refereed to Asadabadi and Haft-Tir marriage counseling centers in Tabriz. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Newly married women during 1 to 3 years ago; Above 18 years of age; Living in one house with husband.
Exclusion criteria:
Pregnancy; being in the postpartum period
Intervention groups
For the first intervention group, CBT will be held in eight sessions including initial sexual evaluation, identifying maladaptive sexual thoughts and beliefs.
For the second intervention group, 5-8 group education sessions, including training about sexual and reproductive system and the stages of the sexual cycle and etc will be held .
Control group: will not receive any intervention.
Main outcome variables
The mean score of sexual satisfaction; The mean score of sexual assertiveness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170506033834N8
Registration date:2021-09-11, 1400/06/20
Registration timing:registered_while_recruiting
Last update:2021-09-11, 1400/06/20
Update count:0
Registration date
2021-09-11, 1400/06/20
Registrant information
Name
Roghaiyeh Nourizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
nourizadehr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-27, 1400/06/05
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of cognitive-behavioral therapy and education based on sexual health self care needs on sexual assertiveness and satisfaction in recently married women: a randomized clinical trial
Public title
Comparing the effect of cognitive-behavioral therapy and education based on sexual health self care needs on sexual assertiveness and satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Recently married (1 to 3 years after marriage)
Living in Tabriz
Has at least middle school education
First time marriage
Monogamy
Living in one house with husband
Exclusion criteria:
Experiencing a severe psychological crisis during the last 6 months, such as the death of relatives
Under 18 years old
Suffering from severe physical diseases (cancers, etc.)
Pregnancy and the postpartum period
Divorce request
Forced marriage
Addiction in One of couples
Mental disorders such as depression or taking psychiatric drugs according to the woman's statement
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned in three groups of cognitive behavioral therapy, education based on sexual health self care needs and control by blocked randomization using Random allocation software with block sizes of 6, 9 and the allocation ratio of 1:1:1.The type of assignment will be written on paper, put in opaque envelopes based on the allocation sequence (allocation concealment). The envelopes will be prepared by a person uninvolved in the sampling process.
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 Committees of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences; Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
0415138947
Approval date
2021-04-26, 1400/02/06
Ethics committee reference number
IR.TBZMED.REC.1400.102
Health conditions studied
1
Description of health condition studied
Sexual assertiveness
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Sexual satisfaction
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Marital Satisfaction
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Sexual self-efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of sexual assertiveness
Timepoint
Before the intervention, and four weeks after the intervention
Method of measurement
Halbert Sexual Assertiveness Questionnaire
2
Description
Score of sexual satisfaction
Timepoint
Before the intervention, and four weeks after the intervention
Method of measurement
Larson sexual satisfaction questionnaire
Secondary outcomes
1
Description
Score of sexual self efficacy
Timepoint
Before the intervention, and four weeks after the intervention
Method of measurement
Vaziri and Lotfi Sexual Self Efficacy Questionnaire
2
Description
Score of marital satisfaction
Timepoint
Before the intervention, and four weeks after the intervention
Method of measurement
Enrich Marital Satisfaction Questionnaire
Intervention groups
1
Description
For the first intervention group, 8 sessions of cognitive-behavioral therapy, once a week for 60 to 90 minutes, which includes initial sexual evaluation, rearrangement of sexual concepts, training sexual rights, and strengthening sexual skills, analyzing the reasons of decreased sexual self-efficacy and its importance in sexual relationship, follow-up and evaluation after the intervention.
Category
Behavior
2
Description
For the second intervention group, 5-8 training sessions based on sexual health self-care needs will be held once a week for 60 minutes, which includes education and information about structure and function of the reproductive system and the stages of the sexual cycle, information about women's rights on sexual and reproductive issues and sexual violence against women and how to achieve sexual assertiveness, healthy and responsible sexual behavior and promoting self-efficacy and Sexual skills.
Category
Behavior
3
Description
Control group: will not receive any intervention. At the end of the study, the most effective intervention will be conducted for the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Asadabadi marriage counseling center
Full name of responsible person
Dr. Nahid Azimzadeh
Street address
Asadabadi marriage counseling center; Next to the agricultural conservatory; Bahar Street
City
Tabriz
Province
East Azarbaijan
Postal code
5184743613
Phone
+98 41 3280 7263
Fax
+98 41 3280 7264
Email
info@asadabadi.tbzmed.ac.ir
2
Recruitment center
Name of recruitment center
7- Tir marriage counseling center
Full name of responsible person
Dr. Ziba Najafi pour
Street address
7- Tir marriage counseling center; Before Nasser Crossroads; Monajjem Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3283 0012
Email
tabrizphc@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Central Building; Tabriz University of Medical Sciences; Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5613974156
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Sanaz Jangi
Position
MSc student of Counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faclty of Nursing and Midwifery; South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
6615615733
Phone
+98 41 3479 0364
Email
sanaz.jangi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faclty of Nursing and Midwifery; South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
6615615733
Phone
+98 41 3479 0364
Email
nourizadehr@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
PhD in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faclty of Nursing and Midwifery; South Shariati Street; Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
977-5138947
Phone
+98 41 3479 6770
Fax
Email
nourizadehr@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD