The effect of sexual counseling based on EX-PLISSIT model on sexual function improvement among married women with Systemic Lupus Erythematosus
Design
This study is a clinical trial with two groups of intervention and control. In each group, taking into account the sample loss, 55 people are randomly selected using random blocking method without blinding. Sexual function score will be assessed using the female sexual function index before and after the intervention.
Settings and conduct
The place of collecting samples and data is Tehran Rheumatology Research Center located in Shariati Hospital affiliated to Tehran University of Medical Sciences. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women older than 18 years, satisfaction to participate in the study, Having Iranian nationality, Having the ability to read and write. Non inclusion criteria: Menopause, pregnancy, participate in any other training class, Taking hormonal drugs or drugs that affect sex, Physical or psychological problems affecting sexual intercourse
Intervention groups
Intervention group: Married women with lupus receiving sexual counseling, sexual counseling based on the EX-PLISSIT model will be performed. Counseling sessions will be held weekly and the number and timing of sessions will be adjusted according to the patient's needs. Control group: Married women with lupus who will not receive any sexual counseling or training and will only be cared for by their physician due to the condition of the disease.
Main outcome variables
sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120414009463N63
Registration date:2021-03-17, 1399/12/27
Registration timing:prospective
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual counseling based on EX‑PLISSIT model on improving the sexual function of married women with Systemic Lupus Erythematosus
Public title
The effect of sexual counseling based on EX‑PLISSIT model on sexual function in Systemic Lupus Erythematosus
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women older than 18 years
satisfaction to participate in the study
Having Iranian nationality
Having the ability to read and write
Exclusion criteria:
Menopause
Pregnancy
Participate in any other training class
Taking hormonal drugs or drugs that affect sex
Depression, anxiety and severe stress according to the score that each person gets from the DASS-21 questionnaire
Physical or psychological problems affecting sexual intercourse
Age
From 18 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
Sampling of this study will be random using block method. In this way, all eligible people enter the study after providing complete explanations and obtaining informed consent and are randomly placed in one of the two intervention or control groups with a quadruple blocking method. In this way, we will consider the letter A for the intervention group and the letter B for the control group. Then write all the permutation compounds of the letters A, A and B, B, which are 6 combinations (AABB for combination 1, ABBA for combination 2, etc.) and from combinations 1 to 6, a combination will be randomly selected. For example, if combination 1 is selected, it means that the first and second people will be in the intervention group and the third and fourth people will be in the control group. Sampling will continue until the desired number of samples in each group is reached.
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 Tehran University of Medical Sciences
Street address
Sixth Floor; Headquarters Building of Tehran University of Medical Sciences; at the corner of Ghods street; Keshavarz Blvd;
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-11-27, 1399/09/07
Ethics committee reference number
IR.TUMS.FNM.REC.1399.136
Health conditions studied
1
Description of health condition studied
Systemic Lupus Erythematosus
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus (SLE)
Primary outcomes
1
Description
Sexual function score in FSFI questionnaire
Timepoint
Before intervention, 8 and 12 weeks after intervention
Method of measurement
DASS-21, FSFI, demographic questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Participants in the study who have inclusion criteria will be randomly assigned to the group receiving sexual counseling by quadruple blocking method. Consulting will be based on the EX-PLISSIT model and the content of the sessions will start with teaching a series of topics and then continue in the form of questions and answers.
Category
Behavior
2
Description
Control group: Participants in the study who meet the inclusion criteria will be randomly assigned to the control group using the quadruple blocking method. This group will not receive any sexual counseling during the study. At the end of the research, an educational booklet will be provided to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Zahra Behboodi-moghadam
Street address
School of Nursing and Midwifery; Nosrat Sharghi street; Tohid square
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8801 6071
Email
maryamshami1870@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Behboodimoghadam
Street address
School of Nursing and Midwifery; Nosrat Sharghi street; Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8801 6071
Fax
+98 21 8801 6071
Email
behboodi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
80
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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery; Nosrat Sharghi street; Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
behboodi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zahra Behboodi Moghadam
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Midwifery and Nursing; Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
behboodi@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
Zahra Behboodimoghadam
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery; Nosrat Sharghi street; Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 4227 6105
Fax
Email
behboodi@tums.ac.ir
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available