Effect of consultation with the approach of motivational interview versus no consultation on sexual satisfaction and body image in women with breast cancer after mastectomy: a randomized clinical trial
Objectives: To assess the effect of consultation with the approach of motivational interview versus no consultation on sexual satisfaction and body image in women with breast cancer after mastectomy.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with breast cancer after mastectomy who will refer to Imam Khomeini Clinic during the study period will be enrolled into the trial.
Inclusion criteria: age of 25 to 60 years; stage of I or II of the disease; completion of chemotherapy; having husband; literate; residence of Hamadan; sexual satisfaction score of 30 to 70.
Exclusion criteria: Lumpectomy; substance abuse; having chronic diseases.
Intervention group: Routine care plus consultation with the approach of motivational interview 45 min once a week for 5 weeks.
Control group: Just routine care.
Primary outcome: (a) assessing sexual satisfaction before and one and three months after intervention using Hudson questionnaire; (b) assessing body image before and one and three months after intervention using Lam questionnaire.
Secondary outcome: Nothing.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of 4 group.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608179014N109
Registration date:2016-08-19, 1395/05/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-19, 1395/05/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of consultation with the approach of motivational interview versus no consultation on sexual satisfaction and body image in women with breast cancer after mastectomy: a randomized clinical trial
Public title
Effect of consultation with the approach of motivational interview versus no consultation on sexual satisfaction and body image in women with breast cancer after mastectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 25 to 60 years; stage of I or II of the disease; completion of chemotherapy; having husband; literate; residence of Hamadan; sexual satisfaction score of 30 to 70.
Exclusion criteria: Lumpectomy; substance abuse; having chronic diseases.
Age
From 25 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization of 4 group.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.UMSHA.REC.1395.219
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
assessing sexual satisfaction
Timepoint
before and one and three months after intervention
Method of measurement
using Hudson questionnaire
2
Description
assessing body image
Timepoint
before and one and three months after intervention
Method of measurement
using Lam questionnaire
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Routine care plus consultation with the approach of motivational interview 45 min once a week for 5 weeks.
Category
Other
2
Description
Just routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Clinic
Full name of responsible person
Fatemeh Zanganeh
Street address
Imam Khomeini Clinic, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
School of Nursing and Midwifery
Full name of responsible person
Fatemeh Zanganeh
Position
Midwifery Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3388 0572
Fax
Email
fatemeh.zangeneh1377@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr Matininia
Position
Fertility Health Specialist
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 4184
Fax
Email
nmatinni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)