Protocol summary

Study aim
To assess the effect of counseling on sexual knowledge, attitude and function in women with sexual dysfunction
Design
This is a randomized clinical trial, in which 80 eligible patients will be randomly assigned to the intervention or control groups
Settings and conduct
The eligible women with sexual dysfunction referring to the Comprehensive Health Centers in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention or control groups through the drawing lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 30 years; Score less than 28 based on the Female Sexual Function Index (FSFI) questionnaire; Ability to speak, read and write in Persian; Married (first marriage). Exclusion criteria: Pregnancy or breastfeeding; Bigamy; Having a child; Separation from a spouse; Suffering from chronic physical or mental illness; Patient or spouse addiction to drugs or alcohol; Use of chemical or herbal medicines that affect sexual function.
Intervention groups
Intervention group: Routine treatment plus counseling sessions (including: the importance of sexual relations, the quality of the couple’s relations, family health, anatomy and physiology of the reproductive system, sexual needs and problems, factors affecting sexual dysfunction, physical and mental differences between men and women, exercise, strategies enhancing sexual desire, improving sexual arousal skills, improving sexual diversity skills, teaching various sexual positions, correcting misconceptions about sex relationship) for 60 to 90 minute weekly for 4 weeks. Control group: Just routine treatment.
Main outcome variables
Sexual function, sexual knowledge, attitude

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N404
Registration date: 2021-10-04, 1400/07/12
Registration timing: prospective

Last update: 2021-10-04, 1400/07/12
Update count: 0
Registration date
2021-10-04, 1400/07/12
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
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling on sexual knowledge, attitude and function in women with sexual dysfunction: a randomized clinical trial
Public title
Effect of counseling on sexual knowledge, attitude and function in women with sexual dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 30 years; Score less than 28 based on the Female Sexual Function Index (FSFI) questionnaire Ability to speak, read and write in Persian Married (first marriage)
Exclusion criteria:
Pregnancy or breastfeeding Bigamy; Having a child; Separation from spouse; Suffering from chronic physical or mental illness; Patient or spouse addiction to drugs or alcohol; Use of chemical or herbal medicines that affect sexual function
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment of the patients to the intervention and control groups through random cluster sampling, the researcher will select eight centers among the Hamadan comprehensive health centers through drawing lots. Then, ten patients will be chosen randomly by drawing lots from referees of each center. For this, the researcher will prepare two sheets with "intervention" or "control" written on them. Then, when each patient refers, they will randomly take one of the sheets, and based on the selected sheet, the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.UMSHA.REC.1400.501

Health conditions studied

1

Description of health condition studied
Sexual dysfunction
ICD-10 code
F52.8
ICD-10 code description
Other sexual dysfunction not due to a substance or known physiological condition

Primary outcomes

1

Description
Sexual function
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
Using the “Female Sexual Function Index” (FSFI) questionnaire

2

Description
Sexual knowledge and attitude
Timepoint
Before the intervention and 4 weeks after that
Method of measurement
Using the “Sexual Knowledge and Attitude Scale” (SKAS) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Routine treatment plus counseling sessions (including: the importance of sexual relations, the quality of the couple’s relations, family health, anatomy and physiology of the reproductive system, sexual needs and problems, factors affecting sexual dysfunction, physical and mental differences between men and women, exercise, strategies enhancing sexual desire, improving sexual arousal skills, improving sexual diversity skills, teaching various sexual positions, correcting misconceptions about sex relationship) for 60 to 90 minute weekly for 4 weeks
Category
Treatment - Other

2

Description
Control group: Just routine treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Health Centers in Hamadan city
Full name of responsible person
Zahra Karami
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahrakarami7697@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Karami
Position
MSc in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahrakarami7697@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Sudabeh Aghababaii
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aghababaii@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...