Investigating the effect of sexual counseling on sexual satisfaction of married women with systemic lupus erythematosus
Design
The clinical trial has a control group, with parallel groups, randomized. In order to carry out the intervention, married women with lupus are divided into two parallel groups (intervention and the control), by random allocation method using block randomization with 4 blocks. In order to hide the allocation, the names of the control and intervention groups are written and placed in closed and opaque numbered envelopes by a person who has no knowledge of the research objectives.
Settings and conduct
Counseling sessions are held in groups of at least 6 people in a private environment in one of Imam Khomeini or Golestan hospitals in Ahvaz by the researcher in person. Before each meeting, a text message will be sent to the participants reminding them of the time and place of the meeting. Before starting the intervention, participants will complete demographic, DASS-21, and Larson's sexual satisfaction questionnaires.
Participants/Inclusion and exclusion criteria
The participants will be all married women with lupus.
Intervention groups
Sexual counseling based on the EX-PLISSIT model will be done for the intervention group. Counseling sessions will be conducted weekly and the number and time of sessions will be adjusted according to the needs of the patient. Participants in the control group will not receive any counseling or educational sessions with the content of improving sexual satisfaction and will only receive routine care for the control and treatment of lupus by the relevant doctor and their treatment team.
Main outcome variables
sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230626058592N2
Registration date:2023-12-09, 1402/09/18
Registration timing:registered_while_recruiting
Last update:2023-12-09, 1402/09/18
Update count:0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Maryam shami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shami.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sexual counseling on improving sexual satisfaction of married women with systemic lupus erythematosus
Public title
The effect of sexual counseling on the sexual satisfaction of married women with 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:
Pregnancy
Menopause
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
Death of spouse
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
Allocation will be random using block method. In this way, all eligible people are included in the study after providing full explanations and obtaining informed consent, and are randomly assigned to one of the two intervention or control groups with a 1:1 allocation ratio using a 6-way block method. In this way, we will consider the letter A for the control group and the letter B for the intervention group. Then write all the permutation combinations of letters A, A, B, B and the number of required blocks will be determined based on the number of studied samples. Then, a combination will be randomly selected from among the combinations using the table of random numbers. Using the table of random numbers will be such that a code will be given to each combination and based on which code is randomly selected from the table of random numbers, the desired code that includes a combination of 6 letters A and B will be selected. For example, according to the combination (AAABBB/ABABAB), the seventh person will be in the control group (A). In order to hide the random allocation, the names of the groups will be placed in opaque, sealed, and numbered envelopes. A person not involved in the sampling process will be asked to pick the envelopes.
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
Research Ethics Committee of Jundishapur University of Medical Sciences, Ahvaz
Street address
Ahvaz, Academic City, Vice-Chancellor of Research and Technology of Jundishapur University of Medical Sciences and Healthcare Services, Ground Floor, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-09-30, 1402/07/08
Ethics committee reference number
IR.AJUMS.REC.1402.333
Health conditions studied
1
Description of health condition studied
sexual satisfaction
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus (SLE)
Primary outcomes
1
Description
sexual satisfaction score
Timepoint
Before intervention, 8 and 12 weeks after intervention
Method of measurement
Larson sexual satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People participating in the research who meet the entry criteria will be randomly placed in the group to receive sexual counseling. The number and duration of the sessions will be determined according to the needs of the people. Counseling will be based on the EX-PLISSIT framework, and the content of the sessions will begin with teaching a series of topics and then continue in the form of questions and answers. At first, based on the first step of the model, people will be allowed to talk about their information, views and opinions about sexual issues, sexual satisfaction of themselves and their spouses. At this stage, by asking open questions, the person will be encouraged to talk about their sexual issues. In the second step, limited information will be presented in the form of photos, collages and using educational tools such as PowerPoint and video in response to the individual's questions and concerns. Information about the impact of the disease on sexual satisfaction, sexual physiology, and sexual behavior will be provided to address misconceptions, myths, lack of awareness, and inadequate sexual skills. This step may include: Changing the context problematic sex, re-educating the patient about specific attitudes and practices, providing advice on different forms of sexual stimulation, screening for mental health issues and identifying interpersonal issues, prescribing hormones and drugs if necessary, and in fact The information provided will help a person to improve sexual performance. In the next step, according to the problems that were evaluated in the previous steps, specific information and suggestions will be given about those problems. If any psycho-psychological disorders or interpersonal conflicts related to sexual function are detected in the previous stages, the patient will need to enter the special treatment stage. Cases such as psychological issues originating from childhood, male sexual dysfunction and couples who need more specialized help in the field of sexual communication will be referred to a psychologist or psychiatrist. These people who were referred to a psychologist or psychiatrist will be excluded from the study.
Category
Behavior
2
Description
Control group:Women participating in the research who meet the inclusion criteria will be randomly assigned to the control group. This group will not receive any sexual counseling during the research. At the end of the research, the educational booklet will be provided to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Maryam Shami
Street address
Azadegan street
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2922
Fax
Email
hemam@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Maryam Shami
Street address
Golestan Koi
City
Ahvaz
Province
Khouzestan
Postal code
33204516
Phone
+98 61 3320 4501
Email
Golestanjpsital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakirkish
Street address
Ground floor, Vice-Chancellor for Research and Technology, Jundishapur University of Medical Sciences and Healthcare Services, Ahvaz, Ahvaz Academic City
City
Ahvaz
Province
Khouzestan
Postal code
61357-15749
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Shami
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery_Jandishapur University of Medical Sciences Ahvaz_Esfand Street_Golestan_Ahvaz_Iran
City
Ahvaz
Province
Khouzestan
Postal code
33337- 61357
Phone
+98 61 3373 8331
Email
maryamshami1870@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Shami
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery_Jandishapur University of Medical Sciences Ahvaz_Esfand Street_Golestan_Ahvaz_Iran
City
Ahvaz
Province
Khouzestan
Postal code
33337- 61357
Phone
+98 61 3373 8331
Email
maryamshami1870@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Shami
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery_Jandishapur University of Medical Sciences Ahvaz_Esfand Street_Golestan_Ahvaz_Iran
City
Ahvaz
Province
Khouzestan
Postal code
33337- 61357
Phone
+98 61 3373 8331
Email
maryamshami1870@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The demographic characteristics of participants are confidential, but information on other variables will be shareable.
When the data will become available and for how long
12 months after the publication of the final article
To whom data/document is available
Researchers in scientific and academic institutions
Under which criteria data/document could be used
Educational and research use is permitted with the permission of the Ethics Committee of Ahvaz University of Medical Sciences. The application should be sent through the Research Vice-Chancellor of Medical Sciences Universities.
From where data/document is obtainable
-
What processes are involved for a request to access data/document