Investigating the Effect of sexual health Intervention intervention on sexual desire and arousal disorder in women with Female Sexual Interest and Arousal disorder(ُّFSIAD) referring to health centers of Ardabil university of medical sciences in 1397
Design
90 women will be randomly divided into two groups of intervention (45 people) and control (45 people). Randomization will be done using a random number table.
Settings and conduct
Qualified women with sexual desire and arousal disorder referring to the health centers of Ardabil city will be randomly allocated into two groups of control and intervention.The intervention group will receive sexual education.Control group will receive routine care and will be attend in a one-day sex education workshop after completing the study.
Participants/Inclusion and exclusion criteria
Women aged 20 to 45 years, having female sexual interest and arousal disorder, married, having a stable life with the spouse in the last 6 months, no stressful event during the past six months, no medical conditions affecting sexual desire, not using effective medications for sexual desire , no sexual dysfunction in the spouse, and consent to participate in the study.
Exclusion criteria: Taking any drug or supplement that interfere with sexual function; Getting pregnant or lactating .
Intervention groups
The intervention group will participate in four sessions of sexual education intervention and will receive an sexual health education package at the fourth session. The control group will not be trained during this period, and after completing the statistical analysis of the study will participate at the educational program.
Main outcome variables
Sexual desire, Sexual arousal, Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180201038583N1
Registration date:2018-07-28, 1397/05/06
Registration timing:registered_while_recruiting
Last update:2018-07-28, 1397/05/06
Update count:0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
pouran akhavan akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 6085
Email address
p.akhavanakbari@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-19, 1397/04/28
Expected recruitment end date
2018-11-19, 1397/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual education package based on qualitative interview in reproductive aged women with sexual interest and arousal disorder (FSIAD)
Public title
The effect of sexual education package based on qualitative interview in reproductive aged women with sexual interest and arousal disorder (FSIAD)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
women aged 20- 45 years ,Married , non pregnant, no lactating, having sexual desire and arousal disorder, having stable relationship with spouse for at least 6 months, no diseases and medical conditions affecting sexual desire, not taking drugs or medications effective in sexual desire, no stressful events during the last 6 months
Exclusion criteria:
Pregnancy, Lactation, Dissatisfaction of women or their husbands to participate in the study
Taking any medication or supplement that interferes with sexual function
Sexual dysfunction of the spouse
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Use the random numbers table
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 Shahid Beheshti University of Medical Sciences
Street address
School of Nursing and Midwifery,Nyayesh intersection, Valiasr Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
تهران ،خیابان ولیعصر
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.SBMU.REC.1395.10
Health conditions studied
1
Description of health condition studied
Female sexual disease
ICD-10 code
F-52
ICD-10 code description
Sexual dysfunction not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual desire
Timepoint
Before intervention and 8 weeks after the study
Method of measurement
Female Sexual Function Index (FSFI)
2
Description
Sexual arousal
Timepoint
Before intervention and 8 weeks after the study
Method of measurement
Female Sexual Function Index (FSFI)
3
Description
Sexual function
Timepoint
Before intervention and 8 weeks after the study
Method of measurement
Female Sexual Function Index (FSFI)
Secondary outcomes
1
Description
Sexual desire and arousal
Timepoint
Before study and 8 week after study
Method of measurement
FSFI Index
2
Description
Sexual function
Timepoint
Before study and 8 week after study
Method of measurement
FSFI Index
Intervention groups
1
Description
Intervention group: The findings of the qualitative study of women with sexual Interest and Arousal disorder identified the non-biological factors affecting sexual desire and the educational needs of Iranian women with sexual dysfunction.In the next step the Sexual Health Model (SHM), Sex Therapy and Cognitive-Behavioral Therapy were also used to complete the educational package.
Category
Behavior
2
Description
Control group: During the study, the control group receives routine health care. After completing the sexual function index (FSFI) in the second phase and completing the statistical analysis of the study, this group will attend a one-day sex education workshop and receive a sexual health education package.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Pilehroudi health center, Shahid Bahonar health center, Seyed Hatami health center, Azadegha
Full name of responsible person
Pouran Akhavan Akbari
Street address
Ardabil city health center, Hafez street, Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Phone
+98 45 3371 4902
Email
p.akhavanakbari@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Research Deputy,School of Nursing and Midwifery , Shahid Beheshti university of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2518
Email
amhdolatian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pouran Akhavan Akbari
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery College Of Shahid Beheshti University of Medical Sciences, Valiasr St, Niayesh Junc, Tehran
City
Tehran
Province
Tehran
Postal code
+98 22523373
Phone
+98 22523373
Email
akhavanakbari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Giti Ozgoli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,Niayesh Crossing,Valiasr Street,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 7188655366021
Fax
+98 21 2219 0684
Email
g.ozgoli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pouran َAkhavan Akbari
Position
Phd Candidate
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery College Of Shahid Beheshti University of Medical Sciences, Valiasr St, Niayesh Junc, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 22523373
Email
akhavanakbari@yahoo.com
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