Compare the effectiveness of Midwifery counseling based on cognitive behavioral counseling approach and conseling based on Extended Permission;Limited information; Specific Suggestion; Referral for intensive therapy( EX PLISSIT) model on sexual function and sexual satisfaction in women during lactation
This study aimed to compare two methods of cognitive-behavioral and Extended Permission; Limited information; Specific Suggestion; Referral for intensive therapy( EX PLISSIT) counseling on function and sexual satisfaction in lactating women up to one year after delivery. Design: A randomized clinical trial without placebo how to do: In this study after obtaining informed consent from lactating women were randomly assigned into two intervention cognitive-behavioral and EX PLISSIT groups and a control group based on six blocks. 34 people will be in every group. Members of the three groups at the first meeting fill up the standard questionnaire female sexual function index (FSFI) and sexual satisfaction Larson. The members of the first intervention group participate on 4 group sessions of counseling based on cognitive behavioral approach that includes the1.5 hour and second intervention group participate on 3 counseling sessions based EX Plissit- approach that includes 1 hour. The control group did not receive any intervention. Immediately and one month after the end of the sessions three groups will respond to post-test. Function and sexual satisfaction scores will be compared between the two intervention groups and between control and intervention groups. Inclusion criteria: living on Neyshabur city; having at least primary education; life with spouse ; having sexual relationship; maximum one year after of delivery; nulliparous; breastfeeding; having psychosomatic healthy; Before entering the study has not been treated sexual problems. Exclusion criteria: happening the stressful event in the past month; taking drugs that affect on sexual function.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040827280N1
Registration date:2016-06-18, 1395/03/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-18, 1395/03/29
Registrant information
Name
Mahdieh Eshghi
Name of organization / entity
Shahroud university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 7213
Email address
eshghi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of Midwifery counseling based on cognitive behavioral counseling approach and conseling based on Extended Permission;Limited information; Specific Suggestion; Referral for intensive therapy( EX PLISSIT) model on sexual function and sexual satisfaction in women during lactation
Public title
The effect of cognitive behavioral counseling and Extended Permission; Limited information; Specific Suggestion; Referral for intensive therapy (EX PLISSIT) model on sexual function and sexual satisfaction in women during lactation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: living on Neyshabur city; having at least primary education; life with spouse ; having sexual relation; maximum one year after of delivery; nulliparous ; breastfeeding; having psychosomatic healthy; Before entering the study has not been treated sexual problems. Exclusion criteria: happening the stressful event in the past month; taking drugs that affect sexual function; in the EX PLISSIT group if you need a referral; the referral is given and the excluded .
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation is done as a block of four. After obtaining informed consent based on cognitive behavioral table assigned to intervention and control groups allocated
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences; Tir Square; Shahroud
City
shahroud
Postal code
3614773955
Approval date
2016-02-25, 1394/12/06
Ethics committee reference number
ir.shmu.iec.1394.192
Health conditions studied
1
Description of health condition studied
Sexual function and satisfacation of lactation period
ICD-10 code
f52.0
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
Sexual function
Timepoint
Before; immediately and one month after intervention
Method of measurement
Female sexual function standard Questionnare
Secondary outcomes
1
Description
Sexual satisfacation
Timepoint
Before; immediately and one month after intervention
Method of measurement
Larson sexual satisfacation standard questionnare
Intervention groups
1
Description
Intervention2:3 sessions counseling based on EX PLISSIT.
Category
Prevention
2
Description
Intervention group1: 4 group sessions based on cognitive behavioral counseling for 1.5 hours.
Category
Prevention
3
Description
control group: Do not receive any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
urban health center
Full name of responsible person
Mahdieh Eshghi
Street address
Central building of Shahroud University of Medical Sciences;Hafte Tir Square;Shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud University of Medical Sciences; Hafte Tir Square; Shahroud
City
Shahroud
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; Shahroud 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
Shahroud university of medical sciences
Full name of responsible person
Mahdieh Eshghi
Position
Master science of student counseling midwifery
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences; Hafte Tir Square; Shahroud.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 7213
Fax
Email
MAHD_MOHAMAD@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Mahbobeh Poorheidary
Position
Faculty member
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences; Hafte Tir Square; Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 1850
Fax
Email
mah_poorheidary@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Mahdieh Eshghi
Position
Master science of student counseling midwifery
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences; Hafte Tir Square; Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 7213
Fax
Email
mahd_mohamad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)