Objective: This study is to determine the effect of counseling based on PLISSIT model on sexual satisfaction and sexual function of pregnant women in Malayer. This study population comprised pregnant women of 24-26 weeks of gestation. The participants will be divided into two groups by using Permutation block randomization. The sample size concludes of 40 patients in the intervention group and 40 patients control group. Inclusion criteria: having any disorder dysfunction confirmed by a psychiatrist; not having any disorder during pregnancy. Exclusion criteria: happening any problem during study. In intervention group counseling will be done in four sessions which each session last for one hour. In this study primary outcome is sexual satisfaction and secondary outcome is sexual function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070713405N11
Registration date:2015-10-15, 1394/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-15, 1394/07/23
Registrant information
Name
Seyyedeh Zahra Masoumi
Name of organization / entity
Hamedan University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
zahra.masoomi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Hamedan University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of consulting based on PLISSIT model on sexual function and satisfaction of pregnant women attending to Health Care Centres
Public title
The impact of consulting on satisfaction and sexual function of pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include: The age range 18-35 years; single fetus and gestational age 24-26 weeks; lack of mental disorders according to psychiatrist
; not having gestational diabetes melitus, preeclampcia, bleeding, premature rupture of membranes; not taking sedative drugs; having sexual dysfunction confirmed by a psychiatrist; not having a history of having sexual dysfunction before pregnancy; exclusively female sexual dysfunction confirmed by psychiatrist. Exclusion criteria includes: occuring any problem in pregnancy during study (abruption, fetal abnormal situation, cord prolapse, bleeding, diabetes, hypertension, preterm labor); abnormal pattern of fetal heart rate or decrease of fetal movements that require medical intervention.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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 Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Fahmideh Ave, Hamedan,Iran
City
Hamedan
Postal code
6516645977
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.UMSHA.REC.1394.225
Health conditions studied
1
Description of health condition studied
Consulting relationship to satisfaction and sexual function
ICD-10 code
F52
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
sexual satisfaction
Timepoint
Before intervention; 2 weeks after intervention; 4 weeks after intervention
Method of measurement
Lindaberg Questionnaire
Secondary outcomes
1
Description
Sextual function
Timepoint
Before intervention; 2 weeks after intervention; 4 weeks after intervention
Method of measurement
FSFI Questionnaire
Intervention groups
1
Description
In the interventional group, meetings once a week over 4 weeks is done in an hour; The first session will talk about the problems of the patient and her sexual function although it may be opposite of therapist’s beliefs. In the second session the therapist gives a brief information about patient’s worries which is educational and directly about sexual problems and concerns of patients ; Specific proposals will be presented at the third session of the patient to enable her to manage her sex problems. In the fourth session focused consultation is done by team psychiatrist.
Category
Early detection
2
Description
just Routine prenatal care is done in control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Number one
Full name of responsible person
Behnaz Nejati
Street address
Valiasr street;Thirty-two yards
City
Malayer
2
Recruitment center
Name of recruitment center
Number tree
Full name of responsible person
Behnaz Nejati
Street address
Tahery street; Brujerd street
City
Malayer
3
Recruitment center
Name of recruitment center
Number four
Full name of responsible person
Behnaz Nejati
Street address
next Baghe gole; Arak street
City
Malayer
4
Recruitment center
Name of recruitment center
Number five
Full name of responsible person
Behnaz Nejati
Street address
GHaem maghami street; alley Mohammadi
City
Malayer
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashiriyan
Street address
Hamedan University of Medical Sciences, Fahmideh Ave, Hamedan,Iran
City
Hamedan
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, Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyedeh Zahra Masoumi
Position
PhD of Reproductive Health/ Deputy School of Nursing and Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamedan University of Medical Sciences, Fahmideh Ave,Hamedan, Iran
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0447
Fax
Email
zahramid2001@yahoo.com;zahra.masoomi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behnaz Nejati
Position
Bachelor of Midwifery/ MA student of consultation in midwifery
Other areas of specialty/work
Street address
Fahmideh Ave, School of nursing and midwifery, Hamedan University of
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
Email
behnaznejati88@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behnaz Nejati
Position
Bachelor of Midwifery/ MA student of consultation in midwifery
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Fahmideh Ave, Hamedan,Iran
City
Hamedan
Postal code
6516645977
Phone
+98 81 3838 0150
Fax
Email
behnaznejati88@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)