Effect of counseling with cognitive behavioral therapy approach versus no counseling on sexual satisfaction and marital quality in women with sexual malfunction: a randomized clinical trial
Objectives: To assess the effect of counseling with cognitive behavioral therapy approach versus no counseling on sexual satisfaction and marital quality in women with sexual malfunction.
Design: a randomized clinical trial.
Setting and conduct: The eligible women sexual malfunction who will refer to Health Centers of Hamadan City during the study period will be enrolled into the trial.
Inclusion criteria: age of 18 to 45 years; married; literate; passing at least 6 months of married life; Hamadan resident.
Exclusion criteria: pregnancy; physical or mental disease; drug or alcohol addiction.
Intervention group: Routine care plus counseling with cognitive behavioral therapy approach 2 hours a week for 8 weeks.
Control group: Just routine care without counseling.
Primary outcome: (a) Assessing sexual satisfaction before and 8 weeks after intervention using Hudson standard sexual satisfaction questionnaire: (b) assessing marital quality before and 8 weeks after intervention using Busby standard marital quality questionnaire
Randomization: The patients will be randomly assigned to intervention and control groups using stratified randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610209014N125
Registration date:2016-10-22, 1395/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-22, 1395/08/01
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
2016-05-24, 1395/03/04
Expected recruitment end date
2017-04-24, 1396/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling with cognitive behavioral therapy approach versus no counseling on sexual satisfaction and marital quality in women with sexual malfunction: a randomized clinical trial
Public title
Effect of counseling with cognitive behavioral therapy approach versus no counseling on sexual satisfaction and marital quality in women with sexual malfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 45 years; married; literate; passing at least 6 months of married life; Hamadan resident.
Exclusion criteria: pregnancy; physical or mental disease; drug or alcohol addiction.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
198
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using stratified randomization.
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
2016-05-23, 1395/03/03
Ethics committee reference number
IR.UMSHA.REC.1395.573
Health conditions studied
1
Description of health condition studied
sexual malfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Assessing sexual satisfaction
Timepoint
before and 8 weeks after intervention
Method of measurement
using Hudson standard sexual satisfaction questionnaire
2
Description
assessing marital quality
Timepoint
before and 2 and 4 weeks after intervention
Method of measurement
using Busby standard marital quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus counseling with cognitive behavioral therapy approach 2 hours a week for 8 weeks.
Category
Treatment - Other
2
Description
Control group: Just routine care without counseling.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nursing and Midwifery
Full name of responsible person
Dr Zahra Massomi
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
Dr Zahra Massomi
Position
Health Fertility 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 0572
Fax
Email
zahramid2001@yahoo.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 Zahra Massomi
Position
Health Fertility 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 0572
Fax
Email
zahramid2001@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)