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Investigation of the Effectiveness of Functional Analytic Psychotherapy (FAP)-Enhanced Cognitive Counselling on the Sexual Quality of Life and Sexual Self-Efficacy of Married Women Adolescent

Protocol summary

Study aim
Determination of the Effectiveness of Functional Analytic Psychotherapy (FAP)-Enhanced Cognitive Counselling on the Sexual Quality of Life and Sexual Self-Efficacy of Married Women Adolescent
Design
Clinical trial with four intervention groups and four control groups, with parallel groups, one blind, Random with simple random assignment, sample size 80
Settings and conduct
This study is carried out on married women adolescent of urban and rural referring to health centers and schools of Darab city and villages. In the intervention group, the functional analytic psychotherapy -enhanced cognitive counselling is conducted by the researcher during 16 sessions of 90 minutes and 2 times a week, and In the control group, common training will be done
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being Iranian, Resident of Darab, Having at least literacy(reading and writing), The stressful incident has not occurred in the past month, Age range is 19-15 years, Her husband is a single wife, No having Towards Extramarital Relations, She is currently living with her husband, Not pregnant, There is no history of surgery in the genital area, Have sex at least once a week, Wife has no sexual problem, Marriage is officially, At least one year has passed since marriage Exclusion criteria: Having special medical condition, having mental and psychological problems, Couples do have drug addiction and alcoholic beverages
Intervention groups
The Intervention group includes married women adolescent from urban and rural schools and are visiting urban and rural health clinics who receive functional analytical psychotherapy enhanced cognitive counseling. The control group includes married women adolescent who receive routine education in schools and clinics.
Main outcome variables
Sexual Quality of Life; Sexual Self-Efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190217042736N1
Registration date: 2019-06-13, 1398/03/23
Registration timing: prospective

Last update: 2019-06-13, 1398/03/23
Update count: 0
Registration date
2019-06-13, 1398/03/23
Registrant information
Name
Maryam GHolami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5362 0111
Email address
maryamgholami121072@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-01, 1398/04/10
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effectiveness of Functional Analytic Psychotherapy (FAP)-Enhanced Cognitive Counselling on the Sexual Quality of Life and Sexual Self-Efficacy of Married Women Adolescent
Public title
Investigating of the Effectiveness of Functional Analytic Psychotherapy (FAP)-Enhanced Cognitive Counselling on the Sexual Quality of Life and Sexual Self-Efficacy of Married Women Adolescent
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian Resident of Darab Having at least literacy (reading and writing) The stressful incident has not occurred in the past month Age range is 19-15 years Her husband is a single wife No having Towards Extramarital Relations She is currently living with her husband Not pregnant There is no history of surgery in the genital area Have sex at least once a week At least one year has passed since childbirth Wife has no sexual problem Marriage is officially Religion is Islam Shia religion At least one year has passed since marriage
Exclusion criteria:
Having special medical condition having mental and psychological problems Couples do have drug addiction and alcoholic beverages Couples do use effective drugs for sexual performance
Age
From 15 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals will be divided into intervention and control groups using simple random assignment by writing names on paper and making a lottery
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
Haftbagh Highway., Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2019-02-23, 1397/12/04
Ethics committee reference number
IR.KMU.REC.1398.091

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

2

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sexual quality of life score
Timepoint
Complete the questionnaire before the intervention and at the meeting3, 5, 7, 9, 11, 13, 15, 16
Method of measurement
Masoumi's Sexual quality of life questionnaire

2

Description
sexual self-efficacy score
Timepoint
Complete the questionnaire before the intervention and at the meeting3, 5, 7, 9, 11, 13, 15, 16
Method of measurement
Vaziri's sexual self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group first: Functional Analytic Psychotherapy-Enhanced Cognitive Counselling, 16 sessions, 2 sessions per week, Compilation by Kohlenberg and T. Sai (1991), Urban schools
Category
Behavior

2

Description
Intervention group second: Functional Analytic Psychotherapy-Enhanced Cognitive Counselling, 16 sessions, 2 sessions per week, Compilation by Kohlenberg and T. Sai (1991), Rural schools
Category
Behavior

3

Description
Intervention group third: Functional Analytic Psychotherapy-Enhanced Cognitive Counselling, 16 sessions, 2 sessions per week, Compilation by Kohlenberg and T. Sai (1991), Urban Clinic
Category
Behavior

4

Description
Intervention group fourth: Functional Analytic Psychotherapy-Enhanced Cognitive Counselling, 16 sessions, 2 sessions per week, Compilation by Kohlenberg and T. Sai (1991), Rural clinic
Category
Behavior

5

Description
Control group: Common training
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Afsorde Shahid school
Full name of responsible person
Masoume Khademi
Street address
Dowlatabad village
City
Darab
Province
Fars
Postal code
7481169371
Phone
+98 71 6532 0111
Email
maryamgholami121072@yahoo.com

2

Recruitment center
Name of recruitment center
Dehkhoda school
Full name of responsible person
Maryam Firoozabadi
Street address
Dowlatabad village
City
Darab
Province
Fars
Postal code
7481169371
Phone
+98 71 5362 0111
Email
maryamgholami121072@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Haftbagh highway, Kerman university medical sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
maryamgholami121072@yahoo.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
Maryam Gholami
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Haftbagh Highway, Kerman university medical sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
maryamgholami121072@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Gholami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Blvd. Valiasr after the bridge of danesh next to the Bureau of Standard Accommodation in Bostan
City
Kerman
Province
Kerman
Postal code
7617613593
Phone
+98 71 5362 0111
Fax
Email
maryamgholami121072@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Gholami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Blvd. Valiasr after the bridge of danesh next to the Bureau of Standard Accommodation in Bostan
City
Kerman
Province
Kerman
Postal code
7617613593
Phone
+98 71 5362 0111
Fax
Email
maryamgholami121072@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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