This study was two-group two-stage clinical trial in which 50 women with breast cancer were selected based on the inclusion criteria through simple continuous sampling and randomly allocated into two groups of study and control.
The inclusion criteria were being aged from 30 to 55 years, being diagnosed for at least 1 month, being under medical treatments, and having passed at least one course of chemotherapy. The exclusion criteria were unwillingness to participate, missing more than 3 sessions and incidence of an acute physical or mental problem.
Ten group educational sessions of spiritual care were organized for the study group while the control group participated in 2 sessions about their experiences of the disease. Data were gathered through Pain Self-Management Checklist, in before and six month after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017083120912N6
Registration date:2017-11-20, 1396/08/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Mohsen Shahriari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2915
Email address
shahriari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-11-23, 1394/09/02
Expected recruitment end date
2016-08-23, 1395/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of spiritual care Program on pain self-management in breast cancer patients
Public title
spiritual care on pain self-management
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria were being aged from 30 to 55 years, being diagnosed for at least 1 month, being under medical treatments, having passed at least one course of chemotherapy and being able to understand and speak Farsi language.
The exclusion criteria were unwillingness to participate, missing more than 3 sessions and incidence of an acute physical or mental problem.
Age
From 30 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Isfahan University of Medical Sciences
Street address
isf ahan, hezarjrib Ave,Isfahan University of Medical Sciences,School of Nursing and Midwifery
City
isfahan
Postal code
Approval date
2013-10-27, 1392/08/05
Ethics committee reference number
292140
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50.9
ICD-10 code description
C50-C50
Primary outcomes
1
Description
pain self-management
Timepoint
pre intervention, 6 weeks after intervention
Method of measurement
Pain Self-Management Checklist
Secondary outcomes
1
Description
none
Timepoint
none
Method of measurement
none
Intervention groups
1
Description
10 group educational sessions of spiritual care
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Mohsen Shahriari
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Attar
Street address
Vice-Chancellery for Research, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Shahriari
Position
academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2950
Fax
Email
shahriari@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Shahriari
Position
Nusing Ph.D
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2950
Fax
Email
shahriari@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Shahriari
Position
academic member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 2950
Fax
Email
shahriari@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)