Protocol summary

Study aim
Design and evaluation the effect of Educational mobile Application on sexual function and sexual quality of life in women with endometriosis under medical treatment
Design
Clinical trial with 100 people in two groups of intervention and control with parallel groups, randomized by random number table
Settings and conduct
n the first stage, the literature was reviewed by searching Persian and English articles in 5 databases, PubMed, Scopus, web of science, Cochran library, Google scholar, with keywords including endometriosis in the title and keywords sexual function, sexual activity, sexual satisfaction, sexual quality of life, sexual dysfunction, sex disorder, dyspareunia, sex education, sex counseling is done in the title or abstract to prepare the content of the application. Then the application is designed by a software engineer and to evaluate the effectiveness of the application, 100 people suffering from endometriosis under medical treatment referring to private offices of endometriosis specialists in Tehran are randomly assigned to the intervention and control groups, and the application is used on the mobile phones of the members. The intervention group is installed and the pamphlet with sex education content is given to the control group
Participants/Inclusion and exclusion criteria
Women between the ages of 18 and 45 with endometriosis diagnosed by ultrasound by a gynecologist who don't have been sexually active during the past month and have a known infertility problem, sexual dysfunction, a known underlying disease, or the use of drugs affecting sexual function in them
Intervention groups
The installation of the educational mobile application for 2 months is done on the mobile phones of the intervention group. The members of the control group are given a pamphlet with the content of sex education
Main outcome variables
sexual function and sexual quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230820059202N1
Registration date: 2024-05-09, 1403/02/20
Registration timing: prospective

Last update: 2024-05-09, 1403/02/20
Update count: 0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Mobina Khorrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
mobinaakhorrami1143@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-30, 1403/03/10
Expected recruitment end date
2024-08-31, 1403/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation the effect of Educational mobile Application on sexual function and sexual quality of life in women with endometriosis under medical treatment
Public title
Design and evaluation the effect of Educational mobile Application on sexual function and sexual quality of life in women with endometriosis under medical treatment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Endometriosis has been diagnosed in them by a gynecologist through ultrasound To be sexually active during the last month There is no known infertility problem in any of the couples There should be no known sexual dysfunction in the male partner such as erectile dysfunction, ejaculation disorder Does not have any known underlying diseases such as mental illness, cardiovascular disease, kidney disease, diabetes, excretory disease, pelvic inflammatory disease and other women's diseases Absence of urinary tract infection, vaginitis, cervical inflammation, active wounds or genital lesions that interfere with sexual intercourse, or a history of sexual assault Women have not used any drugs affecting sexual function such as antidepressants, beta blockers, antihistamines, antipsychotics, benzodiazepines, antiepileptic drugs Couples should not consume cigarettes, alcohol and drugs Not experiencing stressful events (death of a child or a close relative, severe illness of a close relative, imprisonment of a family member, depression, etc.) in the last 3 months The couple has not taken various sex education classes or courses
Exclusion criteria:
Failure to fully complete research questionnaires
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
First, the number of members of the research sample (100 people) is determined. Then study samples are selected through available sampling and a 3-digit sample code is assigned to each of the selected members. Then a table containing 10 rows and 10 columns is prepared in which sample codes are written. In the next step, a row and a column from the table of random numbers are randomly selected as the starting point. Then we start moving in the column or row direction. According to the sample number of 50 people, which is two digits, we select the first two digits of each code, and numbers smaller than the number of the population are selected as the code of the intervention group. This work continues until 50 people are selected as samples and then the remaining people are selected as members of the control group.
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 in Research Faculty of Pharmacy, Nursing and Midwifery, Shahid Beheshti University
Street address
Faculty of Nursing and Midwifery, Vali Asr Street, Intersection of Ayatollah Hashemi Rafsanjani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2023-08-01, 1402/05/10
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.071

Health conditions studied

1

Description of health condition studied
endometriosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
female sexual function
Timepoint
Before starting the intervention
Method of measurement
female sexual performance questionnaire

2

Description
female sexual quality of life
Timepoint
Before starting the intervention
Method of measurement
Questionnaire of the quality of women's sexual life

Secondary outcomes

1

Description
female sexual function
Timepoint
One month and two months after the intervention
Method of measurement
female sexual function questioner

2

Description
female sexual quality of life
Timepoint
One month and two months after the intervention
Method of measurement
female sexual quality of life questioner

Intervention groups

1

Description
Intervention group: In 50 women with endometriosis under medical treatment in the intervention group, an educational application will be installed on the mobile phone and will be available to them for two months and they will be taught to watch the different educational parts of the program in the time order announced
Category
Treatment - Devices

2

Description
Control group: A pamphlet with the content of sex education is given to 50 women with endometriosis under medical treatment in the control group
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Private practice of endometriosis specialists
Full name of responsible person
Khadijah Shadjo
Street address
Unit 14, Plate 5, Veera Alley, Shariati St
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 2671 2056
Email
mobinaakhorrami1143@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
sepideh hajian
Street address
Faculty of Nursing and Midwifery, Vali Asr Street, Intersection of Ayatollah Hashemi Rafsanjani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
s-hajian@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mobina khorrami
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Vali Asr Street, Intersection of Ayatollah Hashemi Rafsanjani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
mobinaakhorrami1143@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mobina khoraami
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti University of Medical Sciences Faculty of Nursing and Midwifery, Ayatollah Hashemi Rafsanjani Highway Intersection, Wali Asr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
mobinaakhorrami1143@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
mobina khorrami
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Vali Asr Street, Intersection of Ayatollah Hashemi Rafsanjani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
mobinaakhorrami1143@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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the information about the samples can be shared in the Excel file after de-identifying the people
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
Access to study documents is free for the public
Under which criteria data/document could be used
The use of study documents is allowed in scientific studies by mentioning the main researcher
From where data/document is obtainable
Send request to email mobinaakhorrami1143@gmail.com
What processes are involved for a request to access data/document
The applicant should send his academic information, the place of use of the study documents, the title of his research or industrial work and the form containing the commitment to mention the main researcher of the documents in his research or industrial work to the email of the main researcher and after checking the eligibility of the information sent, the original researcher will provide them with the documents via email after a week
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