This study determine the effect of counseling based on PLISSIT model on sexual function of pregnant women in Razan. study population is pregnant women of 8-10 weeks of gestation. The participants will be divided into two groups by using Permutation block randomization. The sample size concludes of 43 patients in the intervention group and 43 patients control group. Inclusion criteria: gestational age between 8-10 weeks; First pregnancy and living in the city of Razan.
Exclusion criteria: any problem during study. In intervention group counseling will be done in four sessions which each session last for 40-70 minutes. In this study primary outcome is sexual function
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100324325N1
Registration date:2016-01-22, 1394/11/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-22, 1394/11/02
Registrant information
Name
Farzaneh Khezrian
Name of organization / entity
Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3622 7664
Email address
fkhezrian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of PLISSIT-based Counseling on Sexual Function of Pregnant Women
Public title
Effect of counseling on sexual function of pregnant women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: consent to participate in the study; gestational age between 8-10 weeks; First pregnancy and living in the city of Razan.
Exclusion criteria: any problem during study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
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 Kermanshah University of Medical Sciences
Street address
Opposite Taleghani hospital,Taleghani Blvd,
City
Kermanshah
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
kums.rec.1394.41
Health conditions studied
1
Description of health condition studied
sexual function
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or diseas
Primary outcomes
1
Description
Sexual function
Timepoint
Before and one month after intervention
Method of measurement
Female sexual function index questionnaire
2
Description
Desire
Timepoint
Before and one month after intervention
Method of measurement
Female sexual function index questionnaire
3
Description
Orgasm
Timepoint
Before and one month after intervention
Method of measurement
Female sexual function index questionnaire
4
Description
Lubrication
Timepoint
Before and one month after intervention
Method of measurement
Female sexual function index questionnaire
5
Description
Pain
Timepoint
Before and one month after intervention
Method of measurement
Female sexual function index questionnaire
6
Description
Satisfaction
Timepoint
Before and one month after intervention
Method of measurement
Female sexual function index questionnaire
7
Description
Arousal)
Timepoint
Before and one month after intervention
Method of measurement
Female sexual function index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
control group, at first The FSFI questionnaire was completed by patients and measured level of sexual function in people. In this group the subjects not given counseling and special training and just receiving prenatal care. Finally, a month after the last session of the counseling groups FSFI questionnaire was completed by subjects and level of sexual function is measured and compared
Category
Other
2
Description
intervention group, at first the FSFI questionnaire in order to assess the sexual function completed with intervention group. Then participate in counseling sessions. For individual counseling are using PLISSIT model. unit of the research groups in terms case are participating in consultation meetings that 4 sessions of individual counseling with intervals of 7 days. the time of sessions are 40 to 70 minutes . Finally, a month after the last counseling session sexual function of subjects are assessed and compared.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Number 1 Health Center
Full name of responsible person
Farzaneh Khezrian
Street address
Khanverdiloo Street
City
Razan
2
Recruitment center
Name of recruitment center
Number 2 Health Center
Full name of responsible person
Farzaneh Khezrian
Street address
Farhangian Street
City
Razan
3
Recruitment center
Name of recruitment center
Ghorve Health Center
Full name of responsible person
Farzaneh Khezrian
Street address
Motahari Street
City
Razan
4
Recruitment center
Name of recruitment center
Damagh Health Center
Full name of responsible person
Farzaneh Khezrian
Street address
Imam Street
City
Razan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus hamzehi
Street address
Number 2 Building ,Shahid beheshti Blvd
City
Kermanshah
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 Kermanshah 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
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Marzieh Kaboudi
Position
Ph.D, Scientific Advisory Board
Other areas of specialty/work
Street address
School of Nursing and Midwifery ,Dolatabad
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
fkaboudi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Marzieh Kaboudi
Position
Ph.D, Scientific Advisory Board
Other areas of specialty/work
Street address
School of Nursing and Midwifery ,Dolatabad
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
fkaboudi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Farzaneh khezrian
Position
Master degree, Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery ,Dolatabad
City
Kermanshah
Postal code
Phone
00
Fax
Email
fkhezrian@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)