Aim of this study was conducted to evaluate the effect of group counseling on the body image and sexual satisfaction in women affected by breast cancer. Inclusion criteria: Iranian؛ living in Mashhad؛ The ability to read and write؛ Aged 18 to 50 years؛ lives with his wife؛ Mastectomy؛ At least 6 months from mastectomy؛ chemotherapy؛ radiotherapy and hormone therapy in the past. Exclusion criteria: university education in medicine and psychology؛ Medication for sexual dysfunction؛ disorders of sexual function before the disease؛ psychiatric drugs؛ mental illnesses the disease؛ psychological counseling during the last 6 months. This study clinical trial design with pretest and post-test in the 60 women (18-50 years) with breast cancer who admitted to Omid Hospital Cancer Clinic. Samples are available sampling and randomly assigned to two group intervention (n = 30) and a control group (n = 30).The data collection tool was (BIBCQ) Body Image After Breast Cancer Questionnaire and (ISS) Sexual Satisfaction Instrument completed by participants in the pretest and then in the follow-up post test (after 1 months).The intervention group received counseling of sexual satisfaction and body image, in 4 session (60-90) minute. While the control group routine guidance includes wound care and complications of chemotherapy have received. Data were analysed in SPSS-16 using the paired t-test and the independent t-test.
General information
Acronym
Counseling of Breast Cancer
IRCT registration information
IRCT registration number:IRCT2016100130073N1
Registration date:2017-02-12, 1395/11/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-12, 1395/11/24
Registrant information
Name
Fatemeh Vakili
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
vakilif931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-20, 1395/05/30
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling on body image and sexual satisfaction in women with breast cancer.
Public title
The effect of counseling on body image and sexual satisfaction in women with breast cancer.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian؛ living in Mashhad؛ The ability to read and write؛ Aged 18 to 50 years؛ lives with his wife؛ Mastectomy؛ At least 6 months from mastectomy؛ chemotherapy؛ radiotherapy and hormone therapy in the past.
Exclusion criteria: university education in medicine and psychology؛ Medication for sexual dysfunction؛ disorders of sexual function before the disease؛ psychiatric drugs؛ mental illnesses before the disease؛ psychological counseling during the last 6 months.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Biomedical Research, Mashhad University of Medical Sciences- IR.MUMS.REC
Street address
Building Qureshi, Daneshgah Avenue، mashhad، Khorasan Razavi، Iran
City
Mashhad
Postal code
9138813944
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.MUMS.REC.1395.154
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
Primary outcomes
1
Description
Sexual Satisfaction
Timepoint
Before Intervention, 1 month after intervention
Method of measurement
Standard Questionnaire
2
Description
Body Image
Timepoint
Before Intervention, 1 month after intervention
Method of measurement
Standard Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group، 4 sessions of group counseling (60-90) minutes, twice a week, the number of people in each group 10,counseling in relation to body image and sexual satisfaction after breast cancer have received.
Category
Lifestyle
2
Description
The control group routine guidance includes wound care and complications of chemotherapy have received.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Fatemeh Vakili
Street address
Mashhad University of Medical Sciences
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Research Mashhad University
Street address
Building Qureshi، Daneshgah Avenue، Mashhad، Khorasan Razavi، Iran، Islamic Republic Of
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Talat Khadivzadeh
Position
Reproductive Health PHD
Other areas of specialty/work
Street address
Building Qureshi، Daneshgah Avenue، Mashhad، Khorasan Razavi، Iran، Islamic Republic Of