his randomized clinical trial aimed to evaluate the effectiveness of PLISSIT based sexual counseling on sexual quality of life and sexual function among women aged 35-55 with diabetes type 2. the participants will be recruited in Bahonar hospital based on inclusion criteria after giving informed consent. Random allocation will be done and 55 diabetic women will include in each intervention or control group. Intervention group will receive three, 45 minute sexual counseling sessions 1 weekly. In three times; before, 4 weeks and 8 weeks after intervention SQOL-F , FSFI and Beck II Depression questionnaires will be filled out. Control group just will receive a general health educational pamphlet and 1 sexual counseling session after the study. The effects of counseling between two groups and among groups will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070231662N4
Registration date:2017-08-02, 1396/05/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-02, 1396/05/11
Registrant information
Name
Razieh Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
raziehlotfi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences will fund this project.
Expected recruitment start date
2017-08-21, 1396/05/30
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of sexual counseling using PLISSIT model on sexual quality of life
and sexual function of women with type 2 diabetes mellitus
Public title
The Effectiveness of sexual counseling using PLISSIT model on sexual quality of life
and sexual function of diabetic women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: writing and reading literacy in Persian; being sexual active; aged 35-55; having at least one sexual problem and desire to talk about that. Exclusion criteria: participating in similar classes influencing in sexual function; pregnancy during study; severe conflict in marital relationship and/ or divorce.
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Sciences
Street address
North Taleghani-Azimiyeh
City
Karaj
Postal code
Approval date
2017-04-19, 1396/01/30
Ethics committee reference number
Abzum.Rec.1396.6
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E9
ICD-10 code description
With unspecified complications
Primary outcomes
1
Description
Sexual quality of life
Timepoint
before, 4 weeks , and 8 weeks after intervention
Method of measurement
SQOL-F
2
Description
Sexual function
Timepoint
before, 4 weeks , and 8 weeks after intervention
Method of measurement
FSFI questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
Before, 4 weeks and 8 weeks after intervention
Method of measurement
Beck II Depression questionnaire
Intervention groups
1
Description
Intervention group: 55 diabetic women with at least one sexual broblem will receive three 45 minute individual sexual counseling based on PLISSIT model weekly. Contents of counseling sessions will be anatomy and physiology of genital tract, sexual cycle response, thoughts and emotions, relaxation, Kegel exercise, and sensate focus.
Category
Behavior
2
Description
Ccontrol group: 55 diabetic women with at least one sexual problem will receive a general health educational pamphlet and also one session sexual counseling.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine clinic of Shahid Bahonar Hospital
Full name of responsible person
Maryam Mehrabi
Street address
Shora Blvd., Azimieh, Karaj
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Noorisepehr
Street address
North Taleghani street-Azimyeh
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz University of Medical Sciences- School of Nursing and Midwifery
Full name of responsible person
Maryam Mehrabi
Position
BsC. in Midwifery
Other areas of specialty/work
Street address
1st Golestan-Eshteraki Boulevard-Baghestan-Karaj
City
Karaj
Postal code
Phone
+263 4 304 433
Fax
Email
marimehrabi191@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery-Alborz University of Medical Sciences
Full name of responsible person
Dr. Razieh Lotfi
Position
Assistant Professor
Other areas of specialty/work
Street address
1st Golestan street-Eshteraki Boulevard-Baghestan
City
Karaj
Postal code
Phone
+263 4 334 433
Fax
Email
lotfi_razieh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery- Alborz University of Medical Sciences
Full name of responsible person
Maryam Mehrabi
Position
BSc. in Midwifery
Other areas of specialty/work
Street address
1st Golestan- Eshteraki Boulevard- Baghestan
City
Karaj
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)