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General information
2019-02-04, 1397/11/15
2019-02-19, 1397/11/30
2019-02-0419 00:00:00
2019-04-19, 1398/01/30
2019-04-04, 1398/01/15
2019-04-1904 00:00:00
2019-02-04, 1397/11/15
2019-04-21, 1398/02/01
2019-0204-0421 00:00:00
2019-03-20, 1397/12/29
2019-06-21, 1398/03/31
2019-0306-2021 00:00:00
empty
2019-08-22, 1398/05/31
2019-08-22 00:00:00
empty
Enter new information about sampling date
Enter new information about sampling date
empty
ورود اطلاعات جدید در مورد تاریخ نمونه گیری
ورود اطلاعات جدید در مورد تاریخ نمونه گیری
Protocol summary
Study aim
Determining the Effect of Psychological Training on the Sexual Satisfaction of Women with Breast Cancer
Design
Clinical trials with community based and pragmatic control group, parallel groups, blind, randomized, simple blocked
Settings and conduct
1. Receipt of permission from the vice chancellor for research in Shiraz University of Medical Sciences and referral to Motahhari clinic of Shiraz.
2. Selection of samples and random blocking in two groups of intervention and control by the researcher but the patient does not know which group is located.
3. Complete the demographic questionnaire and sexual satisfaction and sexual schema by both groups.
4. Educational interventions and cognitive therapy by installing the program on the cellphone of the intervention group and using social networks.
5-control group does not see any training.
6. Completion of the questionnaire and analysis.
Participants/Inclusion and exclusion criteria
Entry: Married women with non-metallic breast cancer aged 25-55 years
Non-arrival: Metastatic Breast Cancer Women, Single and Mental Illness
Intervention groups
After placing the samples in the intervention and control groups, the intervention group received training in the field of appropriate exercise for breast cancer, stress management and problem-solving and cognitive therapy interventions, but the control group did not receive any training, and only the questionnaire Completed.
Main outcome variables
"The effect of psychological training on improving female sexual satisfaction"
"Use the results of the plan for future research"
"Promoting Mental Health in Breast Cancer Women"
General information
Reason for update
Enter new information about sampling date
Acronym
IRCT registration information
IRCT registration number:IRCT20190116042377N1
Registration date:2019-01-25, 1397/11/05
Registration timing:prospective
Last update:2019-11-25, 1398/09/04
Update count:1
Registration date
2019-01-25, 1397/11/05
Registrant information
Name
Zeinab Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4331 7905
Email address
hosseini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-06-21, 1398/03/31
Trial completion date
2019-08-22, 1398/05/31
Scientific title
"Psychosocial Intervention on Sexual Satisfaction of Women With Breast Cancer"
Public title
"Sexual Satisfaction in Breast Cancer"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married
Age between 25 to 55 years old
It is associated with non-Metastatic Breast Cancer.
The ability to Read and Write.
Ability to work with Android Mobile Phones.
Medical records in Motahhari clinic in Shiraz.
Would like to participate in this Project.
Exclusion criteria:
The patient will have metastatic Breast Cancer.
Crisis or unexpected illness occurs during research.
Separate your spouse from the research.
Participate in other educational interventions.
Has chronic Psychiatric illnesses.
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
102
Actual sample size reached:
102
Randomization (investigator's opinion)
Randomized
Randomization description
At first, samples are selected using a random Number Table, then randomly blocked by a researcher in Six blocks in two groups of intervention and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
After random selection, samples are entered into two groups of intervention and control in the case of having entered the plan and informed consent for participation in the project. By the fact that the patient knows that he is involved in the research, but in what The group is present and the educational qualities of the groups are not known to the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
School of Nursing and Midwifery, Namaz Square, Shiraz
City
Shiraz
Province
Fars
Postal code
13119–71936
Approval date
2018-12-25, 1397/10/04
Ethics committee reference number
IR.SUMS.REC.1397.915
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
ICD-10 code description
Malignant neoplasm of breastIncl.:connective tissue of breastExcl.:skin of breast (C43.5, C44.5)C50.0Nipple and areolaC50.1Central portion of breastC50.2Upper-inner quadrant of breastC50.3Lower-inner quadrant of breastC50.4Upper-outer quadrant of breastC5
Primary outcomes
1
Description
Sexual Satisfaction Scale in Metson and Traponel Sexual Satisfaction Questionnaire
Timepoint
Measuring sexual satisfaction score before and after intervention
Method of measurement
Scale sexual satisfaction, women Mattson and Trapnl (SSS-W)
Secondary outcomes
1
Description
Sexual schema score
Timepoint
Measuring the score of sexual cognitive schemas before and after intervention
Method of measurement
Questionnaire of Cognitive Schemas Activation in a Sexual Context
Intervention groups
1
Description
Intervention group: "Married women with non-metastatic breast cancer" Three sessions with appropriate sports exercises for breast cancer, stress management, and problem-solving training developed in the form of an application are installed on the mobile phone in the intervention group. This group There are also five sessions of cognitive therapy interventions using social networks that aim at these training and interventions to improve sexual behaviors and patient schemas. "The control group does not receive any training." Just complete the questionnaires before and after the end of the intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhari clinic of Shiraz
Full name of responsible person
Dr.Ali Jangjoo
Street address
Zand Avenue; Namazi Square
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3612 1000
Fax
+98 71 3235 9317
Email
president@sums.ac.ir
Web page address
http://idea.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Yoones Ghasemi
Street address
Research assisstance; Shiraz University of Medical Science; Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
https://internet.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15; Parseh Avenue; Farhangshahr Town
City
Marvdasht
Province
Fars
Postal code
7371798117
Phone
+98 71 4331 7905
Email
z65hosseini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15; Parseh; Avenue; Farhangshahr Town
City
Marvdasht
Province
Fars
Postal code
7371798117
Phone
+98 71 4331 7905
Email
z65hosseini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinab
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15; parseh Avenue; Farhangshahr Town
City
Marvdasht
Province
Fars
Postal code
7371798117
Phone
+98 71 4331 7905
Email
z65hosseini@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available