Objectives: To assess the effect of education versus no education on sexual satisfaction in women during pregnancy.
Design: a randomized clinical trial.
Setting and conduct: The eligible pregnant women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Pregnancy; primigravid; singleton; literate; Iranian.
Exclusion criteria: Contraindication of sexual intercourse; preeclampsia or eclampsia; prom; history of pelvic surgery; heart failure; pulmonary disease; diabetes.
Intervention group: Routine care plus education of sexual intercourse during pregnancy for 1.5 hours once a week for a month.
Control group: Just routine care.
Primary outcome: Sexual satisfaction before intervention and one month later using standard secual satisfaction questionnaire.
Randomization: Random assignment of the patients to the intervention and control groups by drawing lot.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612039014N134
Registration date:2016-12-07, 1395/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education versus no education on sexual satisfaction in women during pregnancy: a randomized clinical trial
Public title
Effect of education versus no education on sexual satisfaction in women during pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pregnancy; primigravid; singleton; literate; Iranian.
Exclusion criteria: Contraindication of sexual intercourse; preeclampsia or eclampsia; prom; history of pelvic surgery; heart failure; pulmonary disease; diabetes.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups by drawing lot.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2013-04-23, 1392/02/03
Ethics committee reference number
P/16/35/9/167
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
O99.8
ICD-10 code description
Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Sexual satisfaction
Timepoint
before intervention and one month later
Method of measurement
using standard secual satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus education of sexual intercourse during pregnancy for 1.5 hours once a week for a month.
Category
Other
2
Description
Control group: Just routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Narges Kheirollahi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Narges Kheirollahi
Position
MSc in Nursing
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
nargeskheirollahi92@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Narges Kheirollahi
Position
MSc in Nursing
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
nargeskheirollahi92@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)