Protocol summary
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Study aim
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The co-effect of sensate focus technique and position changing on sexual function in women with deep-infiltrating endometriosis three to six months after surgery
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Design
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Phase 3 clinical trial, with control group, without blinding, randomized
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Settings and conduct
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Random clinical trial with control group,Endometriosis Clinic in Avicenna Research Institute, and simple randomization and evaluation of interventions one and two months after intervention training
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Participants/Inclusion and exclusion criteria
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Married women aged 18 to 45 years who underwent laparoscopic diagnosis and pathology with deep endometriosis and underwent surgery and referred for follow-up three to six months after surgery and have intercourse in the last 8 weeks.
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Intervention groups
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Intervention group: includes 40 women who have referred for follow-up 3 to 6 months after surgery and are taught sensate focus technique and position changing in a two-hour session. Control group: includes 40 women with deep endometriosis who have undergone surgery.
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Main outcome variables
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sexual function; Sensate focus technique; Position changing
General information
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Reason for update
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Recording the exact time of the start and end of the sampling of the study (the start of the sampling was postponed due to the coronavirus outbreak)
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200617047813N1
Registration date:
2020-10-13, 1399/07/22
Registration timing:
prospective
Last update:
2023-01-28, 1401/11/08
Update count:
1
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Registration date
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2020-10-13, 1399/07/22
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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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2020-11-30, 1399/09/10
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Expected recruitment end date
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2021-12-01, 1400/09/10
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Actual recruitment start date
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2021-01-06, 1399/10/17
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Actual recruitment end date
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2021-09-02, 1400/06/11
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Trial completion date
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2021-09-02, 1400/06/11
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Scientific title
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The co-effect of sensate focus technique and position changing on sexual function in women with deep-infiltrating endometriosis three to six months after surgery
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Public title
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The effect of sensate focus technique and positioning changing on sexual function after endometriosis surgery
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Married women aged 18-45 years
Having intercourse in the last 8 weeks
No known underlying disease other than endometriosis (according to the research unit and the file)
No mental illness (according to the research unit and the file)
Husband monogamy and living with the spouse now and during the study
Literacy of Persian language
Being Iranian and living in Tehran
Non-addiction of couples to drugs and alcohol (according to the research unit and the file)
No stressful incident during the last month (according to the research unit and the file)
Exclusion criteria:
The couple's unwillingness to stay in the study
Getting pregnant while studying
Failure to perform a regular intervention program
Remaining severe surgical complications (according to the research unit and the file)
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Age
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From 18 years old to 45 years old
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Gender
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Female
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Phase
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3
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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:
80
Actual sample size reached:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple random sampling; using Random number table; Even numbers for the intervention group and odd numbers for the control group
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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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2020-10-10, 1399/07/19
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Ethics committee reference number
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IR.MODARES.REC.1399.090
Health conditions studied
1
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Description of health condition studied
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Sexual function
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ICD-10 code
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F52
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ICD-10 code description
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Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
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Description
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Improve sexual function
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Timepoint
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At the beginning of the study and 1 and 2 months after the intervention
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Method of measurement
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FSFI (female sexual function index), VAS ( visual analogue scale)
Intervention groups
1
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Description
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Intervention group: A face-to-face training session is conducted in the form of theoretical training about sensate focus technique and position changing ; with the presentation of training slides. This two-hour workshop will be held individually with spouse in a private and quiet environment
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Category
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Treatment - Other
2
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Description
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Control group: no intervention; and at the end of the evaluation period, a training booklet will be provided to the control group.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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0
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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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Tarbiat Modares university
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Only part of the data, including information about the main outcome, can be shared
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When the data will become available and for how long
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Access efficiency starts from 1401
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To whom data/document is available
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The data will only be available to field researchers
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Under which criteria data/document could be used
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For further research, researchers can send a written request to the responsible author.
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From where data/document is obtainable
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Corresponding Author, Tarbiat Modares University, Faculty of Medical Sciences, Department of Midwifery and Reproductive Health
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What processes are involved for a request to access data/document
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After a written request from the responsible author, the request will be sent to the research unit of Tarbiat Modares University and if the rules are complied with, the analyzed data will be provided to the researchers.
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Comments
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