Protocol summary

Study aim
Comparison between the effect of the information motivation behavioral model and psycho educational counseling on sexual satisfaction and contraception method under coercion of spouse in women referred to Kerman health centers
Design
Clinical trial with control group and two groups of intervention, randomization, 30 patients in control group and 30 patients in psycho educational counseling group and 30 patients in information motivation behavioral group
Settings and conduct
In health centers (Nekouei, Amir Kabir, Imam Hassan Mojtaba) women who are abused and forced by their husbands to use contraception will be randomly divided into three groups: control group receives routine care and information-motivational Behavioral model group and psycho educational group counseling is done. For three groups, a questionnaire will be completed before, after and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have at least one of the criteria for violence against women in relation to contraception according to the checklist of the World Health Organization; Consent to participate in the study; Married women 18 until 45 years; Minimum literacy; Single; Passing At least one year of marriage Exclusion criteria: Pregnancy; Participate in other concurrent psychological counseling sessions
Intervention groups
The effect of information motivational behavioral model and psycho educational counseling on sexual satisfaction and contraceptive methods under the compulsion of the spouse and the control group receives routine care by the midwife.
Main outcome variables
Information motivational behavioral model, psycho educational counseling, Sexual satisfaction, contraceptive methods, coercion of spouse

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151103024866N16
Registration date: 2021-07-27, 1400/05/05
Registration timing: prospective

Last update: 2021-07-27, 1400/05/05
Update count: 0
Registration date
2021-07-27, 1400/05/05
Registrant information
Name
Katayoun Alidousti
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
alidoosti@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of the information motivation behavioral model and psycho educational counseling on sexual satisfaction and contraception method under coercion of spouse in women
Public title
effect of the information motivation behavioral model and psycho educational counseling on sexual satisfaction and contraception method
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least one of the criteria for violence against women in relation to contraception according to the World Health Organization checklist Satisfaction of people to participate in the study Married women aged 18 until 45 whose husbands are present during the intervention in kerman Literacy for reading and writing passing At least one year of marriage
Exclusion criteria:
Known mental illness Non Iranian nationality
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: 90
Randomization (investigator's opinion)
Randomized
Randomization description
To select people using a random table of numbers, the researcher gave a code to each person and randomly started from a point in the table in the direction of a row or column and selected the point by closing his eyes and placing a finger or the tip of a pen on the table. Move in the direction of the row or column. Homogenization in terms of demographic information was performed in two groups of intervention and control.
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 Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-04-13, 1399/01/25
Ethics committee reference number
IR.KMU.REC.1399.036

Health conditions studied

1

Description of health condition studied
Sexual satisfaction and contraception under coercion of spouse in women
ICD-10 code
R45.6
ICD-10 code description
Violent behavior

Primary outcomes

1

Description
Sexual satisfaction
Timepoint
Before and after the intervention and one month after the intervention
Method of measurement
questionary

Secondary outcomes

1

Description
Contraception method
Timepoint
Before and after the intervention and one month after the intervention
Method of measurement
Questionary

Intervention groups

1

Description
First intervention group: In the intervention group, information motivation behavioral model, according to the specific package, counseling sessions will be held in 4 sessions of 90 until 120 minutes, 2 sessions per week. And all these sessions will be held by one person (researcher). The first session: Familiarization of group members, stating the goals and rules of the sessions, defining contraception and its methods with emphasis on the benefits and harms of each method, defining spousal violence in prevention, Sexual satisfaction and sexual satisfaction related to prevention and its benefits. Session 2: Homework feedback, motivational interview to accept or change the method of prevention to make it non-mandatory and increase sexual satisfaction related to it. Session 3: Homework feedback, improving individual skills And perceived self-efficacy of the individual through behavioral techniques such as direct role play or vice versa. Session 4: Homework feedback, activating avoidance behaviors, and developing assertiveness skills by increasing motivation and behavioral skills.
Category
Behavior

2

Description
Second intervention group: In the psycho educational counseling , according to the special package, counseling sessions will be held in three 90-minute sessions at one-week intervals. Session 1: Familiarization of group members, establishing professional communication with group members, stating goals and rules Sessions explaining the subject of the sessions, the duration of the sessions, defining marital satisfaction and its components (such as intimacy, sexual function, etc.) and their importance, defining spousal violence in preventing and informing people about violent behaviors , Teaching contraceptive methods. Session 2: Teaching about improving sexual relations, expressing the importance of sexual relations, talking about sexual misconceptions, Extensive education about contraceptive methods, benefits and harms of contraceptive methods. Session 3: Improving education Sex, expressing the importance of sex, talking about sexual misconceptions, extensive education on contraception, the benefits and harms of contraception.
Category
Behavior

3

Description
Control group: In the control group, routine training is given by the clinic midwife.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Nekouei Health Center
Full name of responsible person
Katayoun Alidousti
Street address
Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5194
Email
kalidousti@gmail.com

2

Recruitment center
Name of recruitment center
Amir Kabir Health Center
Full name of responsible person
Katayoun Alidousti
Street address
Emam Hasan Bolvar
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com

3

Recruitment center
Name of recruitment center
Imam Hassan Mojtaba Health Center
Full name of responsible person
Katayoun Alidousti
Street address
Asiyabad street
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
kalidousti@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kerman, University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@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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