Comparison of the effectiveness of individual counseling based on ex-plissit and GATHER models on sexual function in women with a history of gestational diabetes during lactation
Comparison of the effectiveness of individual
counseling based on ex-plissit and GATHER models on sexual function in women with a history of gestational diabetes during lactation
Design
A randomized controlled clinical trial with parallel groups, without blinding
Settings and conduct
KHorramabad city, Selected clinics, Individual counseling in 2 weekly sessions
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Women with a history of gestational diabetes and currently controlled by diet 2) Breastfeeding 3) Sexual function has started 4) Recent term delivery is single and infant 5) At least 10 and up to 14 weeks postpartum 6) Having at least one problem Sexual 7) Exposure to stressful events during pregnancy and postpartum 8) Available within a month 9) No underlying illness, psychiatric medication and history of any genital surgery 10) At least one year of marriage 11) No participation in counseling and training programs during the past 6 months 12) No postpartum depression 13) No Vaginismus; Study: 1) lack of desire to continue to participate in the study, 2) absence in a maximum of one Azjlsat counseling 3) of something bad happening while studying 4) an addiction 5) Change Location 6) the loss of children 7) away from the wife 8) depression during the study
Intervention groups
Intervention group explissit model: two one-hour sessions of individual counseling per person weekly
Intervention group model: Two one-hour sessions of individual counseling per week
Main outcome variables
Desire; stimulation; orgasm; pain; moisture; sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191013045079N2
Registration date:2020-03-19, 1398/12/29
Registration timing:prospective
Last update:2020-03-19, 1398/12/29
Update count:0
Registration date
2020-03-19, 1398/12/29
Registrant information
Name
hadis fattah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3340 6516
Email address
hadisfth@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of individual counseling based on ex-plissit and GATHER models on sexual function in women with a history of gestational diabetes during lactation
Public title
The effect of sexual function counseling on lactating women with a history of gestational diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A history of gestational diabetes and controlled by current diet
Breastfeeding to the baby
Sexual activity has begun
Recent term labor and single baby
Pass at least 10 and maximum 14 weeks of delivery
Having at least one sexual problem (score less than 28 on the FSFI questionnaire)
Lack of exposure to stressful events during pregnancy and postpartum
Available over the next month
No underlying disease, psychiatric drug use and history of any genital surgery
At least one year of marriage
Failure to participate in counseling and training programs during last 6 months
No postpartum depression
No vaginismus
Exclusion criteria:
Unwilling to continue participating in the study
Failure to attend at least one consultation session
Occurrence of an accident while studying
Addiction
Change of location
Losing a baby
Being away from your spouse
Depression during the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Cluster sampling: According to the cluster sampling, 4 health centers are selected from 4 districts of KHorramabad city. Randomized Blocks Method: Randomly divided people into two groups of 39 for each counseling model
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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences., Alam Hoda Street., Shahid Shiroudi Street., Arak
City
Arak
Province
Markazi
Postal code
6819763383
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.ARAKMU.REC.1398.300
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
Primary outcomes
1
Description
Improve sexual function
Timepoint
Before intervention and 1 month after intervention
Method of measurement
FSFI Women's Sexual Functioning Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the first group, there are two individual counseling sessions based on the explissit model and weekly for one hour. The instruments used were posters, pamphlets and whiteboards. Before and after the intervention, one month after the end of the intervention, sexual function was measured and compared with the second group
Category
Rehabilitation
2
Description
Intervention group:For the second group, two individual counseling sessions based on the GATHER model are offered weekly for one hour. The instruments used were posters, pamphlets and whiteboards. Before and after the intervention, one month after the end of the intervention, sexual function was measured and compared with the first group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
KHorramabad Health Centers
Full name of responsible person
Hadis Fattah
Street address
Deputy of Health., Anushirvan Square
City
KHorramabad
Province
Markazi
Postal code
3814957558
Phone
+98 66 3323 9919
Email
Hadisfth@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
University complex of the Great Prophet., Sardasht
City
Arak
Province
Markazi
Postal code
6819767373
Phone
+98 66 3340 6516
Email
Hadisfth@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hadis Fattah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
University complex of the Great Prophet., Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3503
Fax
Email
hadisfth@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Katayoon Vakilian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Second Floor., Blue Wing Building., Prophet University Academic Complex., Sardasht
City
Arak
Province
Markazi
Postal code
6819767373
Phone
+98 86 3417 3503
Email
cattyv2002@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadis Fattah
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
University complex of the Great Prophet., Sardasht
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3417 3503
Fax
Email
hadisfth@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Main outcome information
When the data will become available and for how long
Access started from 1400
To whom data/document is available
public
Under which criteria data/document could be used
Send researcher an email
From where data/document is obtainable
Original author - Email
What processes are involved for a request to access data/document