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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Protocol summary
This research is a randomized clinical trial with two groups; intervention and control. Sampling will be conducted by simple random allocation.
This research is a randomized clinical trial with two groups; intervention and control. Sampling will be conducted through random allocation using blocks of four
This research is a randomized clinical trial with two groups; intervention and control. Sampling will be conducted by simplethrough random allocation. using blocks of four
این پژوهش از نوع کارآزمایی بالینی تصادفی در دو گروه آزمون و کنترل است که افراد با استفاده از روش تصادفی ساده (قرعه کشی) تقسیم خواهند شد.
این پژوهش از نوع کارآزمایی بالینی تصادفی در دو گروه آزمون و کنترل است که افراد با استفاده از روش بلوک بندی 4 تایی تقسیم خواهند شد.
این پژوهش از نوع کارآزمایی بالینی تصادفی در دو گروه آزمون و کنترل است که افراد با استفاده از روش تصادفی ساده (قرعه کشی)بلوک بندی 4 تایی تقسیم خواهند شد.
the research environment is oncology and Geneology clinic of emem khomeini hospital.Sampling will be conducted by simple random allocation.
the research setting is oncology and Geneology clinic of Emem khomeini hospital.
the research environmentsetting is oncology and Geneology clinic of ememEmem khomeini hospital.Sampling will be conducted by simple random allocationhospital.
محیط پژوهش درمانگاه زنان-انکولوژی بیمارستان امام خمینی می باشد.افراد با استفاده از روش تصادفی ساده به دو گروه تقسیم خواهند شد.
محیط پژوهش درمانگاه زنان-انکولوژی بیمارستان امام خمینی می باشد.
محیط پژوهش درمانگاه زنان-انکولوژی بیمارستان امام خمینی می باشد.افراد با استفاده از روش تصادفی ساده به دو گروه تقسیم خواهند شدباشد.
General information
empty
110
110
empty
2019-07-01, 1398/04/10
2019-07-01 00:00:00
empty
2019-12-21, 1398/09/30
2019-12-21 00:00:00
empty
2020-02-19, 1398/11/30
2020-02-19 00:00:00
empty
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
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
empty
با سلام و احترام
با توجه به اتمام پژوهش، خواستار بروز رسانی بازه دقیق نمونه گیری تحقق یافته هستیم. تشکر
با سلام و احترام با توجه به اتمام پژوهش، خواستار بروز رسانی بازه دقیق نمونه گیری تحقق یافته هستیم. تشکر
In this study, randomization is doing by simple random allocation. It is a technique that chooses individuals for treatment groups and control groups entirely by chance with no regard to the will of researchers or patients' condition and preference. In this study, random allocation is done by tossing a coin.
In this study, eligible participants will be assigned to two intervention and control groups through random allocation using blocks of four.
In this study, randomization is doing by simple random allocation. It is a technique that chooses individuals for treatment groupseligible participants will be assigned to two intervention and control groups entirely by chance with no regard to the will of researchers or patients' condition and preference. In this study,through random allocation is done by tossing a coinusing blocks of four.
در این مطالعه برای تصادفی سازی از روش تخصیص تصادفی ساده به روش قرعه کشی استفاده می گردد. تخصیص تصادفی ساده یکی از رایج ترین و بنیادین روشهای تصادفی سازی است که شانس قرار گرفتن در هر یک از دو گروه مداخله و کنترل را علی رغم تمایل محقق یا شرایط و عملکرد بیمار به میزان مساوی فراهم می کند. تصادفی سازی در این مطالعه با استفاده از روش قرعه کشی به کمک پرتاپ سکه انجام می گیرد.
در این مطالعه افراد واجد شرایط از طریق بلوک بندی 4 تایی به دو گروه مداخله و کنترل تخصیص خواهند یافت.
در این مطالعه برای تصادفی سازیافراد واجد شرایط از روش تخصیص تصادفی سادهطریق بلوک بندی 4 تایی به روش قرعه کشی استفاده می گردد. تخصیص تصادفی ساده یکی از رایج ترین و بنیادین روشهای تصادفی سازی است که شانس قرار گرفتن در هر یک از دو گروه مداخله و کنترل را علی رغم تمایل محقق یا شرایط و عملکرد بیمار به میزان مساوی فراهم می کندتخصیص خواهند یافت. تصادفی سازی در این مطالعه با استفاده از روش قرعه کشی به کمک پرتاپ سکه انجام می گیرد.
Primary outcomes
#1
Before the intervention, 4 and 8 weeks after the intervention
Before the intervention and 8 weeks after the intervention
Before the intervention, 4 and 8 weeks after the intervention
قبل از مداخله، ۴ و ۸ هفته بعد از مداخله
قبل از مداخله، ۸ هفته بعد از مداخله
قبل از مداخله، ۴ و ۸ هفته بعد از مداخله
#2
Before the intervention, 4 and 8 weeks after the intervention
Before the intervention and 8 weeks after the intervention
Before the intervention, 4 and 8 weeks after the intervention
قبل از مداخله، ۴ و ۸ هفته بعد از مداخله
قبل از مداخله، ۸ هفته بعد از مداخله
قبل از مداخله، ۴ و ۸ هفته بعد از مداخله
Protocol summary
Study aim
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
Design
This research is a randomized clinical trial with two groups; intervention and control. Sampling will be conducted through random allocation using blocks of four
Settings and conduct
the research setting is oncology and Geneology clinic of Emem khomeini hospital.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Sexual function؛ Quality of sexual life
General information
Reason for update
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
Acronym
IRCT registration information
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
Registration date
2019-06-29, 1398/04/08
Registrant information
Name
Raziyeh Maasoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
r_masoumi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
2019-07-01, 1398/04/10
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2020-02-19, 1398/11/30
Scientific title
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
Public title
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
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, eligible participants will be assigned to two intervention and control groups through random allocation using blocks of four.
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 of Tehran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, South Nosrat Ave., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3878
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Quality of sexual life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Female Sexual Function Index questioner
2
Description
Quality of sexual life
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
The sexual quality of life-female questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Four psycho-sexual counseling sessions by group training will be recived. The duration of each session will be 60 to 90 minutes.
Category
Other
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Raziyeh Masoumi
Street address
Tehran, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴1
Phone
+98 21 6119 0000
Email
r_masoumi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraian, the Vice Chancellor of Research at Tehran University of Medicine Sciences
Street address
Keshavarz Blv., Qods St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assisstant Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Masoumi
Position
Assisstant Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Masoumi
Position
Assisstant Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data of the study would be available after unrecognizable process of participants.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Research results would be available for academic researchers
Under which criteria data/document could be used
Research results would be available for same researches
From where data/document is obtainable
Dr. Raziyeh Maasoumi email: r_masoumi@sina.tums.ac.ir
What processes are involved for a request to access data/document
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