Protocol summary

Study aim
Investigation the effectiveness of counselling with Dialectical Behavioral approach on Sexual inefficient beliefs and Sexual Dysfunction in couples who are on the verge of marriage
Design
A controlled clinical trial, with parallel, randomized groups, on 50 couples who are on the verge of marriage . Individuals will be divided into tow groups for randomization using online software to generate random sequences and by block random allocation method with four blocks.
Settings and conduct
First the researcher , after obtaining the code of ethics from the ethics committee of Kerman University of Medical Sciences and obtaining the code of clinical trial and presenting it to Kerman University of Medical Sciences, the researcher with a letter of introduction ,refers to Sina Premarital Counseling Center in Sirjan . A list of all referring couples will be provided to the researcher and they will be included in the study randomly and if they have inclusion criteria and conscious satisfaction . The random sampling method will be simple.
Participants/Inclusion and exclusion criteria
minimum age: 15 years old ، Having at least the fifth grade elementary ، Be one's first marriage ، Lack of any known physical illnesses، Lack of any significant psychiatric disorders، No addiction or smoking،
Intervention groups
The counseling group will receive10 sessions of 90 minutes ( two sessions per week) ، The man and woman will receive Dialectical Behavioral Therapy counseling together. The control group does not receive any intervention .
Main outcome variables
Sexual inefficient beliefs and Sexual Dysfunction in couples who are on the verge of marriage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201027049164N5
Registration date: 2021-12-16, 1400/09/25
Registration timing: prospective

Last update: 2021-12-16, 1400/09/25
Update count: 0
Registration date
2021-12-16, 1400/09/25
Registrant information
Name
Masumeh Ghazanfarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5856
Email address
m.ghazanfarpour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effectiveness of counselling with Dialectical Behavioral approach on Sexual inefficient beliefs and Sexual Dysfunction in couples who are on the verge of marriage
Public title
Investigation the effectiveness of counselling with Dialectical Behavioral approach on Sexual inefficient beliefs and Sexual Dysfunction in couples who are on the verge of marriage
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
minimum age: 15 years old at least having the fifth grade elementary Be one's first marriage Lack of any known physical illnesses such as diabetes and vascular disease and chronic diseases and hormonal disorders and cancer diseases Lack of any significant psychiatric disorders of anxiety and depression and significant psychiatric neurological symptoms No addiction or smoking
Exclusion criteria:
Absence of more than two sessions in counseling sessions Failure to follow instructions and relevant exercises in sessions Lack of cooperation of authorities and lack of answers to questionnaire questions Occurrence of acute accidents and unexpected at each stage of the plan Acute and chronic diseases infection during the study
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomizing the selection: numbers from 1 to 100 will be allocated to the participants, respectively, then using the random block allocation method with four blocks, individuals will be divided into two groups of 50. How to place people in each of the counseling groups and control will be random, which will be done using online software to generate random sequences (www.randomizer.org/). In order to hide the process of random allocation and prevent bias, the selection of this action will be done after the final list is prepared by a person other than the main researcher and the researcher will be obliged to act exactly accordingly.
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
Deputy of Research and Technology; ebne-e-Sina St., Jahad Blvd., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2021-11-19, 1400/08/28
Ethics committee reference number
IR.KMU.REC.1400.458

Health conditions studied

1

Description of health condition studied
Sexual inefficient beliefs
ICD-10 code
Z70
ICD-10 code description
Counseling related to sexual attitude, behavior and orientation

Primary outcomes

1

Description
Sexual inefficient beliefs
Timepoint
Beginning of the study (before the start of the intervention) and end of the intervention and three months after the end of the intervention ( after the marriage of the couples )
Method of measurement
Sexual dysfunctional beliefs questionnaire pinto-Gouveia -Nuber (SDBQ)

Secondary outcomes

1

Description
Sexual dysfunction
Timepoint
Three months after the end of the Counseling sessions (after the marriage of the couples)
Method of measurement
Female sexual function index questionnaire and international index of erectile function questionnaire

Intervention groups

1

Description
Intervention group: The counseling group will receive10 sessions of 90 minutes ( two sessions per week) ، The man and woman will receive Dialectical Behavioral Therapy counseling together.
Category
Treatment - Other

2

Description
Control group: They will only receive routine classes Premarital without any other interventions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sirjan Premarital Counseling Center
Full name of responsible person
Rezvan Khaleghi
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Sirjan
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5278
Email
rkhaleghi87@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
Tahmasbabad cross road, Vice Chancellor for Research and Technology building
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
rkhaleghi87@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
Rezvan Khaleghi
Position
Masters student
Latest degree
Bachelor
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
76169-13555
Phone
+98 34 3132 5700
Email
rkhaleghi87@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masumeh Ghazanfarpour
Position
Assistant professor
Latest degree
Ph.D.
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 5856
Email
M.ghazanfarpour@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Khaleghi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Beginning of the axis of seven Alavi Gardens, Campus of the University of Medical Sciences, Faculty of Nursing and Midwifery
City
Keman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
rkhaleghi87@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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