Protocol summary
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Study aim
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Determine the Effect of Psycho-Sexual Counseling Based on EX-PLISSIT Model on Sexual Function and Sexual Quality of life in patients with the Most Common gynecological Cancers
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Design
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This research is a randomized clinical trial with two groups; intervention and control. Sampling will be conducted through random allocation using blocks of four
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Settings and conduct
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the research setting is oncology and Geneology clinic of Emem khomeini hospital.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: having reading and writing literacy, ,Having a live husband, definitive diagnosis of one of the three endometrial, cervical or ovary cancers, Stay at a time of at least 3 and not more than 6 months after the end of the surgical treatment, sexually active over the last 6 month؛ exclusive criteria: positive history of well- known psychiatric illness that has an effect on sexual relationships, Use of sexual desire decreasing drugs, substance abuse and alcohol consumption, Experience of bad event within 3 months before the start of the study, such as (death of loved ones and ...), Having well-known sexual dysfunction before having a cancer, positive history of attending sex education or receiving sex counseling services, Patients with cancer who are under radiotherapy, positive history of marital affair, Unwillingness to participate in any of the stages of the research and not attending more than
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Intervention groups
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Intervention group: Four sessions of intervention each session receives 60 to 90 minutes of psycho-sexual counseling based on the EX-PLISSIT model.
Control group: The control group will not receive any intervention until the end of the research. Then, based on the ethics of the research and their willingness Can use researcher psycho-sexual counseling.
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Main outcome variables
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Sexual function؛ Quality of sexual life
General information
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Reason for update
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Dear referee
Due to the completion of this trial, I would be grateful if you could permit us to update the actual recruitment date.
Best Regards
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160808029255N6
Registration date:
2019-06-29, 1398/04/08
Registration timing:
prospective
Last update:
2021-10-22, 1400/07/30
Update count:
1
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Registration date
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2019-06-29, 1398/04/08
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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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2017-11-22, 1396/09/01
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Expected recruitment end date
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2019-08-22, 1398/05/31
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Actual recruitment start date
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2019-07-01, 1398/04/10
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Actual recruitment end date
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2019-12-21, 1398/09/30
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Trial completion date
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2020-02-19, 1398/11/30
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Scientific title
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The Effect of Psycho-Sexual Counseling Based on EX-PLISSIT Model on Sexual Function and Sexual Quality of life in patients with the Most Common gynecological Cancers
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Public title
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The Effect of Psycho-Sexual Counseling Based on EX-PLISSIT Model on Sexual Function and Sexual Quality of life in patients with the Most Common gynecological Cancers
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
having reading and writing literacy
Married
Having a live husband
A definitive diagnosis of one of the three endometrial, cervical or ovarian cancers based on medical documentation
Stay at a time of at least 3 and not more than 6 months after the end of the surgical treatment
Stay in remission and follow-up treatment based on medical documentation
sexually active
Exclusion criteria:
Positive history of well-known psychiatric illness that has an effect on sexual relationships (self-report)
Use of sexual desire decreasing drugs(self-report)
Substance abuse and alcohol consumption (self-report)
Experience of bad event within 3 months before the start of the study, such as (death of loved ones and ...)
Having well-known sexual dysfunction before having a cancer (self-report)
Positive history of attending sex education or receiving sex counseling services
Patients with cancer who are under radiotherapy
Positive history of marital affair (self-report)
Unwillingness to participate in any of the stages of the research and not attending more than one of the intervention sessions
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Age
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From 18 years old to 60 years old
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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:
110
Actual sample size reached:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, eligible participants will be assigned to two intervention and control groups through random allocation using blocks of four.
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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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2017-11-05, 1396/08/14
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Ethics committee reference number
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IR.TUMS.FNM.REC.1396.3878
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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ICD-10 code description
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2
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Description of health condition studied
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Quality of sexual life
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Sexual function
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Female Sexual Function Index questioner
2
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Description
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Quality of sexual life
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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The sexual quality of life-female questioner
Intervention groups
1
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Description
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Intervention group: Four psycho-sexual counseling sessions by group training will be recived. The duration of each session will be 60 to 90 minutes.
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Category
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Other
2
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Description
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Control group: The control group will not receive any intervention until the end of the research. Then, based on the ethics of the research and their willingness the educational program will be presented by the researcher.
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Category
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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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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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Tehran 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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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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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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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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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Data of the study would be available after unrecognizable process of participants.
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When the data will become available and for how long
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6 months after publishing the results
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To whom data/document is available
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Research results would be available for academic researchers
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Under which criteria data/document could be used
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Research results would be available for same researches
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From where data/document is obtainable
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Dr. Raziyeh Maasoumi email: r_masoumi@sina.tums.ac.ir
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What processes are involved for a request to access data/document
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Sending a request by email attendance to the office of corresponding of project presentation the reasons for similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in office of corresponding author
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Comments
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