Objectives: To assess the effect of counseling versus no counseling on sexual satisfaction in women with sexual desire disorder.
Design: A randomized clinical trial.
Setting and conduct: The eligible women with sexual desire disorder who will refer to clinics of Hamadan city during the study period will be enrolled into the trial.
Inclusion criteria: hypoactive sexual desire; age of18 to 49 years; the ability to read and write, at least one year has passed from marriage.
Exclusion criteria: pregnancy or breastfeeding; having chronic disease; mental disorders; using OCP; non-continuous participation in training sessions.
Intervention group: Routine healthcare plus 7 counseling session twice a week 90 minutes each.
Control group: Just routine healthcare without counseling.
Primary outcome: (a) Measuring hypoactive sexual desire before intervention and one month later using questionnaire; (b) Measuring sexual satisfaction before intervention and one month later using Hudson's questionnaire.
Secondary outcome: Nothing.
Randomization: Random assignment of the patients to the intervention and control groups.
Blinding: Blinding is not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607059014N106
Registration date:2016-07-20, 1395/04/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-20, 1395/04/30
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
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling versus no counseling on sexual satisfaction in women with sexual desire disorder: a randomized clinical trial
Public title
The effect of counseling versus no counseling on sexual satisfaction in women with sexual desire disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hypoactive sexual desire; age of18 to 49 years; the ability to read and write, at least one year has passed from marriage.
Exclusion criteria: pregnancy or breastfeeding; having chronic disease; mental disorders; using OCP; non-continuous participation in training sessions.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups.
Blinding: Blinding is 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
2016-06-25, 1395/04/05
Ethics committee reference number
IR.UMSHA.REC.1395.176
Health conditions studied
1
Description of health condition studied
sexual desire disorder
ICD-10 code
F52.0
ICD-10 code description
Lack or loss of sexual desire
Primary outcomes
1
Description
Measuring hypoactive sexual desire
Timepoint
before intervention and one month later
Method of measurement
using questionnaire
2
Description
Measuring sexual satisfaction
Timepoint
before intervention and one month later
Method of measurement
using Hudson's questionnaire
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Routine treatment plus 7 counseling session twice a week 90 minutes each.
Category
Other
2
Description
Just routine healthcare without counseling
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nursing and Midwifery
Full name of responsible person
Banafsheh Bojarzadeh
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh 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
School of Nursing and Midwifery
Full name of responsible person
Banafsheh Bojarzadeh
Position
Midwifery Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
b.bojar99@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr Farzaneh Soltani
Position
Fertility Health Specialist
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
farzanehsoltani2008 @yahoo.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)