Objective: present study will conduct with the aim of effect of social support based group Intervention on loneliness among women with mastectomies.
The most important of inclusion criteria: having experienced mastectomy procedures within 4-24 last month; having public health based on GHQ scale and the most important of exclusion criteria: having another type of cancer.
The study of population and sample size: This study will carry out on 80 Women with Mastectomies in Urmia city.
Intervention: The program of intervention will be in 6 group sessions in dimensions emotional, tools and informational support. Sessions will be held with a focus on communication and make friends, communication with family and friends, coping, stress management and answer questions. The control group received no intervention.
Main outcome: Social Support; Improve loneliness
Variables: loneliness
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031516564N3
Registration date:2015-07-16, 1394/04/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-16, 1394/04/25
Registrant information
Name
Molood Radfar
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1275 4961
Email address
radfar.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Social Support Based on Group Intervention on Loneliness among Women with Mastectomies
Public title
The Effect of Social Support on Loneliness
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having experienced a mastectomy procedures within 4-24 last month, having general health based on GHQ scale; awareness of the disease
ٍٍExclusion criteria: having another type of cancer, the experience of other stressful events within 6 last month; absence of more than two sessions
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Resalat boulevard, next to the emergency
City
Urmia
Postal code
Approval date
2014-07-15, 1393/04/24
Ethics committee reference number
Ir.umsu.rec.1393.108
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm: Breast, unspecified
Primary outcomes
1
Description
loneliness
Timepoint
Before the intervention - at the end of the intervention - two months after the end of intervention
Method of measurement
with UCLA questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: The program of intervention will be in 6 group sessions in dimensions emotional, tools and informational support. Sessions will be held with a focus on communication and make friends, communication with family and friends, coping, stress management and answer questions. The control group received no intervention.
Category
Lifestyle
2
Description
The control group received no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Medical Documentation Center
Street address
Ershad avenue
City
Urmia
2
Recruitment center
Name of recruitment center
Imam Reza hospital of Urmia
Full name of responsible person
Medical Documentation Center
Street address
Molavi avenue
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences, Vice Chancellor of Research
Full name of responsible person
Erag Mohebbie
Street address
Urmia University of Medical Sciences and Health Service, next emergency center, Resalat Blvd
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University of Medical Sciences, Vice Chancellor of Research
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
Urmia University of Medical Sciences
Full name of responsible person
Zeinab Taei
Position
Master of Nursing
Other areas of specialty/work
Street address
Urmia Faculty of Nursing and Midwifery
City
Urmia
Postal code
5714995143
Phone
+98 984432754961
Fax
Email
zbtaeih14000@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Moloud Radfar
Position
Phd of nursing
Other areas of specialty/work
Street address
Urmia Faculty of Nursing and Midwifery
City
Urmia
Postal code
5714783734
Phone
+98 984432754961
Fax
Email
mradfar1343@gmail.com Radfar.m@umsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
zeinab taei
Position
Master of Nursing
Other areas of specialty/work
Street address
Urmia Faculty of Nursing and Midwifery
City
Urmia
Postal code
5714783734
Phone
+98 984432234897
Fax
Email
zbtaeih14000@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)