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The effectiveness of consuling with EXPLISSIT approach on sexual function and marital satisfaction in newly delivered women: A Randomized Controlled Trial

Protocol summary

Study aim
Determine the effectiveness of consuling with EXPLISSIT approach on sexual function and marital satisfaction in newly delivered women: A Randomized Controlled Trial
Design
The selected individuals will be assigned by random blocking with blocks 4 and 6 with a ratio of 1: 1 to two groups (Consultation recipient and control, 34 people for each group), the type allocation will be written on the paper and placed in the opaque packets numbered down, the pockets will be opened in the order of the individuals entering the study and the type of group will be specified.
Settings and conduct
The study will be in the health centers of Ardabil city and in the intervention group, sexual counseling will be given by the trained midwife during a 60-90 minute or more session in accordance with the EXPLISSIT model and participants in control group get routine care.
Participants/Inclusion and exclusion criteria
Having at least a literacy guide; score less than 28 from the FSFI questionnaire; single lactating women being between 3 and 6 months after childbirth; having a call number to follow up; husband's monogamous. Exclution criteria: exposure to a stressful event or any complication of pregnancy; having a history of depression; having a history of chronic physical and mental illness; use of any drug that is effective on sexual response; child with known anomalies or preterm; marriage separation; the death of the baby after delivery for any cause; addiction to a person or his wife; the history of sexual dysfunction in couples before pregnancy.
Intervention groups
Intervention group: in the intervention group, sexual counseling will be given by the trained midwife during a 60-90 minute or more session in accordance with the EXPLISSIT model and will be based on the concerns and needs of the participants. Control group: get routine care
Main outcome variables
Sexual function; marital satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111122008170N12
Registration date: 2018-05-02, 1397/02/12
Registration timing: prospective

Last update: 2018-05-02, 1397/02/12
Update count: 0
Registration date
2018-05-02, 1397/02/12
Registrant information
Name
Jamileh Malakouti
Name of organization / entity
Nursing Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1477 2699
Email address
malakoutij@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of consuling with EXPLISSIT approach on sexual function and marital satisfaction in newly delivered women: A Randomized Controlled Trial
Public title
The effectiveness of consuling with EXPLISSIT approach on sexual function and marital satisfaction in newly delivered women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least a literacy guide according to the person herself Score less than 28 from the Female Sexual Function Index questionnaire (FSFI ) Single lactating women Being between 3 and 6 months after childbirth Having a call number to follow up Husband's monogamous
Exclusion criteria:
Exposure to a stressful event or any complication of pregnancy during pregnancy and postpartum (for example: death of a family members) according to the person herself Having a history of depression pre-pregnancy, during pregnancy and postpartum according to the person herself Having a history of chronic physical and mental illness such as cardiovascular disease, diabetes, severe depression and high blood pressure that consumes the drug according to the person herself Use of any effective medicines on person's sexual response, (antihypertensive drugs, thiazide diuretics, antidepressants, antihistamines, Barbiturates, narcotics, diazepins, amphetamines and cocaine) according to the person herself Child with known anomalies or preterm (less than 37 weeks) Marriage separation (emotional divorce or full divorce) The death of the baby after delivery for any cause Addiction to a person or his wife according to the person herself The history of sexual dysfunction before pregnancy in couples (including disorders of sexual desire or orgasm in women, early and late ejaculation, erectile dysfunction and male orgasm) according to the person herself
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
The selected individuals will be assigned by random blocking using the RAS software with blocks 4 and 6 with a ratio of 1: 1 to two groups (Consultation recipient and control, 34 people for each group), the type allocation will be written on the paper and placed in the opaque packets numbered down, the pockets will be opened in the order of the individuals entering the study and the type of group will be specified. The allocation sequence will be performed by the person not involved in the sampling and collecting of data.
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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences Research & Technology, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
51665118
Approval date
2018-03-05, 1396/12/14
Ethics committee reference number
IR.TBZMED.REC.1396.1131

Health conditions studied

1

Description of health condition studied
Sexual dysfunction in women newly delivered
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease

Primary outcomes

1

Description
Sexual function score
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire

2

Description
Marital satisfaction score
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Enrich Marital Satisfaction questionnaire

Secondary outcomes

1

Description
Quality of sexual life score
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Female sexual quality of life questionnaire

Intervention groups

1

Description
Intervention group: In the intervention group, sexual counseling will be given by the trained midwife during a 60-90 minute or more session in accordance with the EXPLISSIT model and will be based on the concerns and needs of the participants
Category
Prevention

2

Description
Control group: Get routine care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Ardebil
Full name of responsible person
Robab Gholizadeh
Street address
Ardebil, Ayatollah Moghadas Ardebili St., Shahid Moadi St., Alawi Medical Education Center
City
Ardebil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
205rgh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolgasem Jouyban
Street address
Tabriz University of Medical Sciences, Gulgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
Robab Gholizadeh
Position
Student of Master in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ardebil, Ayatollah Moghadas Ardebili St., Shahid Moadi St., Alawi Medical Education Center
City
َArdabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
205rgh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Malakouti.Jamileh
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, South Shariati Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
66156-15733
Phone
+98 41 3479 6770
Email
jamilehmalakouti@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Robab Gholizadeh
Position
Student of Master in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Ardebil, Ayatollah Moghadas Ardebili St., Shahid Moadi St., Alawi Medical Education Center
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
205rgh@gmail.com

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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of the clinical study will be published as a paper.
When the data will become available and for how long
Immediately after printing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific use with reference to article
From where data/document is obtainable
E-mail: malakoutij@tbzmed.ac.ir
What processes are involved for a request to access data/document
Up to a week after correspondence by email
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