Determining the effect of educational intervention based on illness perception on the sexual satisfaction of women with breast cancer
Design
In this study, 80 patients with breast cancer who are eligible for inclusion in the study are selected and randomly divided in to control and intervention groups.
Settings and conduct
This clinical trial study was conducted on the sexual satisfaction of patients with breast cancer referred to the Qazvin Velayat hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married; 18-53 y; treatment has finished; ability for responsive
Exclusion criteria: History of physical & sexual & psychological disorders; unwillingness; presence in another consultation treatment.
Intervention groups
The Intervention group includes women with breast cancer who have sexual unsatisfaction and receive illness perception education.
Control group:Just stages of follow-up after therapy,such as the experimental group send and no training not receive.
Main outcome variables
Sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037903N1
Registration date:2018-05-03, 1397/02/13
Registration timing:registered_while_recruiting
Last update:2018-05-03, 1397/02/13
Update count:0
Registration date
2018-05-03, 1397/02/13
Registrant information
Name
Seyyedeh Maryam Abedini Gilani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 7267
Email address
m.abedinigilani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-09, 1396/11/20
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of illness perception educational intervention's on sexual satisfaction of women with breast cancer
Public title
Effect of illness perception on sexual satisfaction in breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Difinite diagnosis of breast cancer
Check out stages of therapeutic
Married
Physical& mental appropriate to responsive
Exclusion criteria:
History of sexual dysfunction before breast cancer
History of psychological disorder before breast cancer
History of any disorder before breast cancer
The presence in an other consultative treatment
Unwillingness
Age
From 18 years old to 53 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of random groups with quadruple block's in two groups(control& intervention)
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 ofQazvin University of Medical Science
Sextual satisfaction measured by the Larsson questionnaire
Timepoint
Before intervention and just after intervention
Method of measurement
Larsson sexual satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention-based illness perception individual(education face-to- face)in3session 30minute every3 weeks will run among themorning shift.First session:meeting of the first after its contact primary with the patient and ask questions about understanding the disease current and their implications,then content of the desired to see the will be. This session based on 5 of illness perception and effects of psychology its Foundation is. This dimensions includes; the nature of the disease(labels and symptoms)due to the beginning disease,understanding one of the disease(time inform the person of the disease),outcom and findings of the expected one of the disease,effective control and treatment and improve disease will be. For intervention illness perception exercises self-control and encouragment verbal and design of objective(like improve sexual satisfaction)feedback and evaluation of experiences successful people will be used. The second session; after reviewing the training previous patient want the uncertainties and questions possible about your disease raise. In this session interventions unique based on the need patient set will was training in order to change misunderstanding and negative patients to see the will be. At the end of the second session manual training,including detect and definition of disease,training exercises different physical(such as Kegel) and recommendations psychological plain language and understandable and based on the latest reference scientific world to seethe will be. Third session;includes evaluation and closing that the previous session at this meeting to the patient information will be notified first meeting includes review training session previous.Then the patient information impact of training and experience new questions will be. Finally,problems and obstacles forany patients will be.
Category
Treatment - Other
2
Description
Control group:Just stages of follow-up after therapy,such as the experimental group send and no training not receive.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Seyedeh Maryam Abedini Gilani
Street address
Golha SQ,22Bahman Blvd,Minoodar ST
City
Qazvin
Province
Qazvin
Postal code
34174
Phone
+98 28 3379 0620
Email
M.abedinigilani@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
DR Amir Peymani
Street address
Beheshti Blvd,Mavadat ST
City
Qazvin
Province
Qazvin
Postal code
34156
Phone
+98 28 3333 7006
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Maryam Abedini Gilani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin Medical University, Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415674785
Phone
+98 26 3340 8143
Email
iranabed1234@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Maryam Abedini Gilani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin Medical University, Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415674785
Phone
+98 26 3340 8143
Email
iranabed1234@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Maryam Abedini Gilani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin Medical Science University,Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3415674785
Phone
+98 28 3334 3024
Email
iranabed1234@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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available