This aim of this study is to compare the effect of Extended PLISSIT (EX-PLISSIT) counseling and group counseling on sexual function and sexual satisfaction among pregnant women. This study is a randomized controlled trial. The study population will be pregnant women referred to health care centers in the Zanjan city. Participants will be assign to two intervention and one control groups and each group will consist of 37 pregnant women. After obtaining informed consent, the first intervention group will receive the EX-PLISSIT counselling and the second one will receive client-centered group counseling. The control group will receive routine care. Participants will be married women with normal pregnancy who are in the first or second trimester of pregnancy and have no medical contraindication to do sexual activity during pregnancy. The main outcomes of this study will be sexual Function and satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021225477N2
Registration date:2017-03-31, 1396/01/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-31, 1396/01/11
Registrant information
Name
Elahe Ahmadnia
Name of organization / entity
Social determinants of health center
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 9192
Email address
ahmad@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahroud University of Medical Sciences
Expected recruitment start date
2017-03-15, 1395/12/25
Expected recruitment end date
2017-07-15, 1396/04/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing The Effect Of Extended PLISSIT and Group Counseling On Sexual Function and Satisfaction Of Pregnant Women
Public title
Comparing The Effect Of Two Methods Of Counseling On Sexual Function and Satisfaction In Pregnant Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Nulliparity; Monogamous; Non-specific and chronic diseases; absence of contraindication for sexual activity during pregnancy; absence of sexual dysfunction according to the physician diagnosis; not receiving formal education about sexual activity during past 6 months; No history of psychiatric disorders at least in the last year; not using drugs such as imipramine, Diazpoxide, Opioid or Alcohol. Exclusion criteria: conditions that prohibit sexual intercourse, serious interpersonal problems between couples.
Age
From 12 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
111
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Approval date
2016-07-22, 1395/05/01
Ethics committee reference number
IR.SHMU.REC.1395.80
Health conditions studied
1
Description of health condition studied
Sexual Function and Sexual Satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual Satisfaction
Timepoint
Baseline and 4 Weeks after Intervention
Method of measurement
Hadson Sexual Satisfaction
2
Description
Sexual Function
Timepoint
Baseline and 4 Weeks after Intervention
Method of measurement
FSFI Standardized Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 (Extended PLISSIT counselling): In this group, 2-4 Individual counseling sessions will be held weekly for each participant.
Category
Other
2
Description
Intervention group 2 (Client-centered group counseling): the participants will be divided into five 7-8 member groups and 4-5 group counseling sessions will be held for them. Each session will take about 1 to 1.5 hours.
Category
Other
3
Description
Control group: routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care centers in Zanjan
Full name of responsible person
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
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
Elahe Ahmadnia
Position
Ph.D candidate in Fertility health
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
Phone
+98 23 3344 7195
Fax
Email
ahmad@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences
Full name of responsible person
Elahe Ahmadnia
Position
Ph.D candidate in Fertility health
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud.
City
Shahroud
Postal code
Phone
+98 23 3344 7195
Fax
Email
ahmadnea52@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences
Full name of responsible person
Elahe Ahmadnia
Position
Ph.D candidate in Fertility health
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud.
City
Shahroud
Postal code
Phone
00
Fax
Email
ahmadnea52@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)