The effect of sexual counseling and sexual education based on self-efficacy theory on sexual function and marital satisfaction of women with breast cancer
Determining the effect of sexual education and counseling based on self-efficacy theory on sexual function and marital satisfaction of women with breast cancer
Design
This intervention is a randomized controlled clinical trial with parallel groups. Samples (50 Patient ) will be randomly assigned into 2 groups by block method (25 in control group and 25 in intervention group).
Settings and conduct
Participants will be selected from breast cancer patients referred to the hematology department of a hospital in Bushehr city and hematology clinic, who have medical records and meet the study criteria. The purpose of the study will be explained to them through interviews. Written consent forms will be obtained from individuals who are willing to participate. Then, the sexual function questionnaire will be completed by each woman diagnosed with breast cancer. If these patients have at least one area of sexual dysfunction and their sexual function score in each area is below 3.9, it will be considered a disorder, and they will be included in the study. After that, the marital satisfaction questionnaire will be completed by women with breast cancer.This study was not blinded.
Participants/Inclusion and exclusion criteria
Inclusion: Have breast cancer and at least have lobectomy, Women of childbearing age, Being married, Has done radiation therapy or chemotherapy at least 3 months ago, Have problems in at least one field of sexual function.
Exit criteria:Severity of illness, Pregnancy, use of psychiatric medications and sexual function enhancing drugs,Have disorders that disrupt sexual function
Intervention groups
In the intervention group, two training sessions and three counseling sessions based on self-efficacy theory will be held, and the control group will be given a booklet in the end.
Main outcome variables
Sexual function and marital satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231102059930N1
Registration date:2023-12-04, 1402/09/13
Registration timing:registered_while_recruiting
Last update:2023-12-04, 1402/09/13
Update count:0
Registration date
2023-12-04, 1402/09/13
Registrant information
Name
Azadeh Jamshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 272 5235
Email address
azadejam17@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual counseling and sexual education based on self-efficacy theory on sexual function and marital satisfaction of women with breast cancer
Public title
The effect of sexual counseling and sexual education on sexual function and marital satisfaction of women with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have breast cancer and at least have lobectomy.
Women of childbearing age.
Being married.
Have enough physical ability to attend meetings.
Has done radiation therapy or chemotherapy at least 3 months ago.
Have willingness to participate in the research.
Have problems in at least one field of sexual function.
Exclusion criteria:
Pregnant patients.
Patients using psychiatric medications.
Have a history of using drugs to improve sexual function.
Have disorders that disrupt sexual function(ovarian removal in women, mental problems, Alzheimer's and mental retardation and multiple sclerosis).
Have received sexual education and sexual counseling at least 6 months before the research.
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into intervention and control groups by block randomization method. 5 blocks of 10 numbers will be used for blocking.At first, blocks of ten numbers are named with the labels A (intervention group) and B (control group), which will have 252 different states.Then 5 blocks are randomly selected from among the blocks. By choosing each block of ten numbers based on the order of letters, patients are placed in one of two groups, that is, with each block, 5 chances are given to each group.
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 Bushehr University of Medical Sciences
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2023-07-05, 1402/04/14
Ethics committee reference number
IR.BPUMS.REC.1402.071
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
sexual function
Timepoint
Before the intervention begins, after the intervention, as well as one month after the intervention
Method of measurement
Women's Sexual Function Questionnaire 19 questions
Secondary outcomes
1
Description
Marital Satisfaction
Timepoint
Before the intervention begins, after the intervention, as well as one month after the intervention
Intervention group: Holding 2 training sessions and three counseling sessions based on self-efficacy theory for one month and weekly follow-up by phone to answer questions one month after the end of the intervention.
Category
N/A
2
Description
Control group: There is no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Hematology shohadaye khalij Hospital
Full name of responsible person
Azadeh Jamshidi, senior consultant in midwifery
Street address
shohadaye khalij Hospital, Bushehr, Bushehr Province
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۷۹۳۳۷۵۵
Phone
+98 77 3345 5381
Email
azadejam17@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Akram Farhadi
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr
City
بوشهر
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
azadejam17@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Bushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Tayebeh Gharibi
Position
Trainer of Bushehr midwifery school
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
tayebehgharibi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Tayebeh Gharibi
Position
Trainer of Bushehr midwifery school
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
school of nursing and midwifery,Bushehr university of medical sciences,Rishehr avenue, Sabzabad avenue, Bushehr