This is a quasi-experimental study with an interventional group and a control group. This medical research has been done for the analysis of the effect of the consultation on sexual function in women with type 2 diabetes mellitus. The study population included the married women with sexual dysfunction from 20 to 50 years old will be fill the sexual function questionnaire by Rosen. Available participants enrolled and then randomly divided in to both the intervention group and the control groups. Program of sex consultation in this study is 3 sessions will last 90 minutes once a week. In First meeting will be describe about anatomy of the female reproductive system, sexual cycle and the factors involved in its, second session on the types of sexual disorder and to describe the effect of diabetes on sexual function in women. Also the treatment strategies offered. In third session will be provided solutions for better courtship and more intimacy in relationships and summary and overview of previous contents Entries will be done. In this study, the control group received only the center's routine care. Impact assessment sessions will be conducted two months after the last training session (intervention group) and the control group, by refilling the FSFI questionnaire will be compared with previous surveys. At the end of the eight week training package will be given to the control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403033037N7
Registration date:2014-05-16, 1393/02/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-16, 1393/02/26
Registrant information
Name
Mehrnaz Geranmayeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 1669
Email address
geranmay@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-04, 1393/02/14
Expected recruitment end date
2014-09-22, 1393/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of consultation on sexual dysfunction in women with type 2 diabetes mellitus
Public title
Effect of consultation on sexual function in women with type 2 diabetes mellitus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: at least 6 months have passed their Diagnosis of type 2 diabetes (doctor); not taking any medications that affect sexual function such as, antidepressant and anti hypertensive drug; not having disease such as heart disease, hyperthyroidism, hypothyroidism, liver and renal failure; couples are not addicted to drugs and alcohol; not pregnant, not lactation; married and living with spouse stable; couples living together have at least the past 1 year married; monogamy for men; during the last 6 months of emotional stress (such as the death of first-degree relatives) are not; no severe complications from diabetes, such as infection; having at least 20 years of age; the lack of menopause; lack of participation in training classes with a focus on sex education; not the spouses of women suffering from premature ejaculation or impotence; couples do not have a mental illnesses such as depression.
Exclusion criteria: occurrence of diseases in women or their husbands' influence on sexual function, including cardiovascular disease, psychological, thyroid and cancers; start taking drugs that affect sexual functioning during this manner; serious marital dispute; history of a traumatic event during the past 6 months such as death of first-degree relatives; gynecologic problems, including vaginal bleeding; amputation during the follow-up; to become pregnant.
Age
From 20 years old to 55 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,Qods St., Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-02-07, 1392/11/18
Ethics committee reference number
130/2640/د/92
Health conditions studied
1
Description of health condition studied
sexual dysfunction in women with type 2 diabetes mellitus
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
sexual function in women with type 2 diabetes mellitus
Timepoint
before intervention and then two month later
Method of measurement
FSFI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will receive sex consultation. Program of sex consultation in this study is 3 sessions will last 90 minutes once a week. In First meeting will be describe about anatomy of the female reproductive system, sexual cycle and the factors involved in its, second session on the types of sexual disorder and to describe the effect of diabetes on sexual function in women. Also the treatment strategies offered. In third session will be provided solutions for better courtship and more intimacy in relationships and summary and overview of previous contents Entries will be done.
Category
Treatment - Other
2
Description
Control group will receive only the center routine care. At the end of the eight week training package will be given to the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Therapeutic Educational 5 ََََAzar Hospital
Full name of responsible person
Maryam Moradi
Street address
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of tehran University of Medical Sciences
Full name of responsible person
Dr.Masoud yonesian
Street address
Keshavarz Blvd, Qods St., Tehran University of Medical Sciences
City
Tehran
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 of tehran 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
Tehran Nursing and Midwifery Faculty
Full name of responsible person
Maryam Moradi
Position
The Masters of midwifery student
Other areas of specialty/work
Street address
School of Midwifery and Nursing,Tohidsquar, Tehran
City
Tehran
Postal code
Phone
+98 17 1232 9735
Fax
Email
m.moradi48@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Nursing and Midwifery Faculty
Full name of responsible person
Mehrnaz Geranmayeh
Position
Academic faculty member
Other areas of specialty/work
Street address
Tehran Nursing and Midwifery Faculty, Tohidsquar
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
geranmay@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Moradi
Position
The master of Midwifery student
Other areas of specialty/work
Street address
Tehran Nursing and Midwifery Faculty
City
Tehran
Postal code
Phone
00
Fax
Email
m.moradi48@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)