Protocol summary

Summary
This study is to determine the effect of counseling based on PLISSIT model on sexual function of women after delivery in Bandarabbas.This study population comprised Lactating women during First six month after delivery.This is a quasi experimental-controlled study and The participants will be divided into two groups by using Permutation block randomization. The sample size concludes of 45 patients in the intervention group and 45 patients in the control group. Inclusion criteria: having sexual problem; primiparous women. Exclusion criteria: happening any problem during study (such as pregnancy). In intervention group counseling will be done in one session which last for one hour. In this study primary outcome is sexual function.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062522921N1
Registration date: 2015-11-06, 1394/08/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-06, 1394/08/15
Registrant information
Name
Mojdeh Banaei
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 9020
Email address
m.banaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology، Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2016-02-29, 1394/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Consultation Based on PLISSIT model On sexual function of women during First six month after delivery
Public title
The Effectiveness of Consultation Based on PLISSIT model On sexual function of women during First six month after delivery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: primiparous and lactating women after a term singleton delivery؛ during 6 months after delivery؛ having at least one sexual problem (FSFI score<28؛ lack of stressful events during pregnancy and after childbirth؛ lack of complications in pregnancy and after childbirth؛ lack of mental and chronic physical illness. Exclusion criteria: becomes pregnant؛ lack of access to participation؛ the loss of the baby؛ away from his wife.
Age
From 20 years old to 39 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
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 Shahid Beheshti University of Medical Science
Street address
Shahid Beheshti University of Medical Sciences،Velenjak St، Shahid Chamran Highway، Tehran، Iran
City
Tehran
Postal code
1985717443
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
SBMU2.REC.1394.96

Health conditions studied

1

Description of health condition studied
sexual problem
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction,not caused by organic disorder or disease

Primary outcomes

1

Description
Sexual Function
Timepoint
Before intervention; 4 weeks after intervention
Method of measurement
FSFI Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
just Routine consultation is done in control group.
Category
Other

2

Description
In the interventional group, a meeting is done in an hour; that will talk about the problems of the patient and her sexual function although it may be opposite of therapist’s beliefs. In the next step the therapist gives a brief information about patient’s worries which is directly about sexual problems and concerns of patients ; Specific suggestions will be presented at the next step of the patient to enable her to manage her sexual problems. finally focused consultation is done by team psychiatrist.
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
An urban Health center (Imam Hossein) affiliated to Bandarabbas University of Medical Sciences
Full name of responsible person
maryam sharifinasab
Street address
No.69، Niyayesh Ave، Imam Hossein Street، Bandarabbas، Iran
City
Banddar abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research and Technology، Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Rezghi
Street address
Shahid Beheshti University of Medical Sciences،Velenjak St، Shahid Chamran Highway، Tehran، Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and Technology، Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojdeh Banaei
Position
Midwifery master student
Other areas of specialty/work
Street address
Shahid Beheshti University of Medical Sciences،Velenjak St، Shahid Chamran Highway، Tehran، Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 2243 9888
Fax
+98 21 2243 9889
Email
Mojdeh.Banaei@Gmail.com ؛ Banaei.M@sbmu.ac.ir
Web page address
info@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahnaz Toork Zahrani
Position
Academic Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery، Shahid Beheshti University of Medical Sciences،Valiasr Ave. Tehran. Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
Zahranishahnaz@yahoo.com
Web page address
sbnmf@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojdeh Banaei
Position
Midwifery Master Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery، Shahid Beheshti University of Medical Sciences، Valiasr Ave. Tehran. Iran
City
Tehran
Postal code
1985717443
Phone
+98 21 2387 2219
Fax
+98 21 2243 9889
Email
Mojdeh.Banaei@gmail.com
Web page address
www.sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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