Protocol summary
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Study aim
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Designing and evaluating an intervention program based on the needs and strategies for improving the sexual health of women with endometriosis
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Design
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The study has three phases. Phase one: women with endometriosis and experts, sample size in the qualitative study until data saturation is reached. Phase two: sample size of the quantitative part of the study of 70 women with endometriosis (35 in the intervention group) and ( 35 people in the control group). Sampling of the quantitative phase of the study will be non-random and accessible sampling, and people who have the conditions and completed the online informed consent form to participate in the project will be selected as research units.
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Settings and conduct
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The study is conducted in GYN clinic and 70 women who are willing to participate in the research are invited by telephone and randomly divided into two intervention and control groups, and the intervention group receives the intervention in ETA.
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Participants/Inclusion and exclusion criteria
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Suffering from endometriosis, married, having sex with spouse, Iranian, having informed consent; Pregnancy, participation in an intervention study, addiction, presence of mental disorder, drug use in the last 60 days, suffering from other chronic diseases, stressful events in the last 6 months.
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Intervention groups
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For the intervention group, in addition to providing routine care, the designed intervention (it should be noted that the content of the intervention will be determined based on the findings of the first and second phases of the study, including the solutions obtained from the qualitative study and literature review) will be presented on an authorized virtual network such as ETA. became. For the control group, an educational booklet about sexual health in endometriosis will be given.
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Main outcome variables
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Quality of sexual life and sexual performance of women
General information
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Reason for update
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Greetings and Regards.
Due to the fact that the current research is a mixed method study (qualitative phase-quantitative phase), therefore, the start date of the quantitative phase and sampling is from 6/12/2023 to 15/3/2024 and we have not started the intervention yet. Therefore, due to entering the wrong date of sampling and correcting some items, this update is done.
Thanks
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220620055229N2
Registration date:
2023-03-07, 1401/12/16
Registration timing:
prospective
Last update:
2023-07-01, 1402/04/10
Update count:
1
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Registration date
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2023-03-07, 1401/12/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-12-06, 1402/09/15
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Expected recruitment end date
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2024-03-15, 1402/12/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Developing and evaluating an interventional program based on the needs and strategies for improving the sexual health of women with endometriosis: A mixed method Study
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Public title
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The effect of an intervention program on the sexual health of women with endometriosis
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with endometriosis based on the diagnosis of a gynecologist
Being Iranian
Being married
Having sex with your wife
Having informed online consent to participate in the study
Exclusion criteria:
Being pregnant
Participating in concurrent sexual health-related intervention studies
Having cancer or chronic diseases
Existence of various types of severe mental disorders (psychosis, schizophrenia) under medical treatment based on medical record information or statements
Drug and alcohol addiction
Using any drug or hormone affecting sexual performance within 60 days before the intervention
Existence of stressful events during the last 6 months such as immigration, death of relatives, divorce and acute financial problems
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Age
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No age limit
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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First, 70 samples were invited to the study by the third moderator by telephone, and then by using the sequence of random numbers through the online software (www.Random.org/sequences), the women were assigned to two intervention groups (35 people) and control group (35 people).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-02-19, 1401/11/30
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Ethics committee reference number
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IR.SSU.RSI.REC.1401.018
Health conditions studied
1
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Description of health condition studied
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endometriosis
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ICD-10 code
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N80.0
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ICD-10 code description
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Endometriosis of uterus
Primary outcomes
1
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Description
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Quality of sex life
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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Questionnaire of the quality of sexual life of Simond women
Secondary outcomes
1
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Description
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Women's sexual performance
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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Rozen Women's Sexual Performance Questionnaire
Intervention groups
1
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Description
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Intervention group: For the intervention group, in addition to providing routine treatment for endometriosis, an intervention was designed (it should be noted that the content of the intervention will be determined based on the findings of the first and second phases of the study, including the solutions obtained from the qualitative study and literature review) on the virtual network. Authorized as it will be provided.
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Category
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Behavior
2
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Description
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Control group: For the control group, an educational booklet about sexual health in endometriosis will be given
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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All personal data of participants can be shared after de-identification.
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When the data will become available and for how long
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After printing the results
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To whom data/document is available
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The data will be available for researchers working in academic and scientific institutions, and people who are busy can apply to receive them.
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Under which criteria data/document could be used
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Scientific use
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From where data/document is obtainable
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fatemehzaremobini@yahoo.com
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What processes are involved for a request to access data/document
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One week after receiving the applicant's email
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Comments
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