Effect of educational package on sexual function of female sexual frigidity of reproductive age
Design
Of two health centers, 80 women aged 20 to 40 are randomly selected. Participants are randomly assigned to two intervention and control groups and each participant is assigned a code, and the demographic data, the degree of depression, sexual function, and temperament of the sample are compiled.
Settings and conduct
In this research, two health care centers are selected by randomization. Then one is assigned for control and the other for intervention group by drawing method
Participants/Inclusion and exclusion criteria
Inclusion criteria: sexual function score (FSFI) <28; sexual frigidity determination score <14.
Exclusion criteria in the beginning of the study: Taking medicine affecting sexual function; happening stressful events during the past 6 months for any of couples.
Intervention groups
In intervention group each participant take part in 2 sessions per week for 3 weeks. ( each training class lasts for 60 minutes) while the control group do not take place in training classes. After four weeks sexual function, temperament assessment and depression questionnaires are given to both control and intervention groups.
Main outcome variables
Sexual function score with FSFI questionnaire
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20170623034717N1
Registration date:2018-01-02, 1396/10/12
Registration timing:retrospective
Last update:2018-01-02, 1396/10/12
Update count:0
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Nasim Baradaran Akbarzadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3763 4651
Email address
baradarann941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences, Mashhad, Vice Chancellor for research
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-08-05, 1396/05/14
Actual recruitment end date
2017-11-30, 1396/09/09
Trial completion date
empty
Scientific title
Effect of educational package on the sexual function of cold-temper women in the reproductive age
Public title
effect of education on sexual function
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
female gender
haviIranian cold-tempered womenng consent letter
aged 18 to 40
Muslim
the participants must be educated.
living in Mashhad
having sexual activity in the last 4 weeks
Body mass index between 19.8_29 kg/m2
sexual function score (FSFI) <28
Tempered type determination score <14
The allocated groups are females whose scores in depression, anxiety and stress questionnaire are lesser than 14, 10 and 17, respectively
Exclusion criteria:
Taking medicine affecting sexual function
happening stressful events during the past 6 months for any of couples
being under psychiatric treatment for mental disorders
having severe depression
drug or alcohol addiction in any of couple
No tendency to cooperate with research team
having major conflicts with husband
studying books or consulting about sexual issues during the past 6 months
studying books or consulting about marital relations during the past 6 months
being under treatment for sexual dysfunction in any of couple
taking medicine lead to change in sexual desire during the past 3 months
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random sampling method (random table number), two health centers are selected from five health centers in Mashhad. These centers assigned to the two group of intervention and control groups using coin throw.
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 Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreshi building, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.MUMS.REC.1396.39
Health conditions studied
1
Description of health condition studied
Other sexual disorders
ICD-10 code
F66
ICD-10 code description
Other sexual disorders
Primary outcomes
1
Description
Improve female sexual function
Timepoint
Before intervention, immediately after intervention.
Method of measurement
Sexuality Questionnaire (FSFI).
Secondary outcomes
1
Description
pain
Timepoint
4 weeks after the end of the intervention
Method of measurement
Visual Analogue Scale (0 to 10)
Intervention groups
1
Description
Specific training will be given, three weeks, twice a week, each session 60 minutes to the intervention group by lecture, question and answer and group discussion
Category
Lifestyle
2
Description
Control group: without training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Abas abad Health Center
Full name of responsible person
Dr Asna Ashar
Street address
9th street, Kamyab Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9181111111
Phone
+98 51 3735 8906
Email
baradarann941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
Ghoreshi bulding
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 7313
Email
baradarann941@mums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nasim Baradaran Akbarzadeh
Position
Master of Midwifery (student)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doktora Crossroads, Ebne Sina Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3760 6724
Fax
Email
baradarann941@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
Midvifery Master
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing Midwifery Faculty, Doktora Crossroads, Avicenna Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9181111111
Phone
+98 51 3605 0971
Fax
Email
tafazolim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nasim Baradaran Akbarzadeh
Position
Midwifery Master
Latest degree
Bachelor
Other areas of specialty/work
Street address
Mashhad Nursing Midwifery Faculty, Doktora Crossroads, Avicenna Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3760 6724
Fax
Email
baradarann941@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We have not a plan for publishing our individualized participants data.