Effect of a designed pain management program education on pain and quality of life of cancer patient with moderate to severe pain in chemotherapy and radiotherapy units in Nemazee hospital _ Shiraz 1389
The objective of this randomized control study was to investigate the effect of an educational pain management program on pain intensity and quality of life among Iranian cancer patients. In this study 60 patients (control group=30, experimental group=30) who diagnosed with cancer, treatment with chemo and radiotherapy, experiencing pain (4 & >4) related to cancer with doctor diagnosed. and Patients with pain related to treatment, participant in other educational pain management program were excluded this study.
The data were collected by means of the Brief Pain Inventory and EORCT QLQ - C30 questionnaire. Patients in the experimental group received education that consists of 6 session educational pain management during 6 week. Patients in the control group received routine clinical care.the patients pain intensity assess in both groups at the first interview, 2, 4 and 8 weeks after intervention and quality of life assess before, 4 and 8 weeks after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110012812N3
Registration date:2011-12-30, 1390/10/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-30, 1390/10/09
Registrant information
Name
Farkhondeh Sharif
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1212 2401
Email address
fsharif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciense
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a designed pain management program education on pain and quality of life of cancer patient with moderate to severe pain in chemotherapy and radiotherapy units in Nemazee hospital _ Shiraz 1389
Public title
Impact of educational pain management program on pain intensity and quality of life in cancer patients
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria were patients:1) diagnosed with cancer,2) treatment with chemo and radiotherapy 3) experiencing pain (4 & >4) related to cancer with doctor diagnosed 4) over the age of 18 years old 5)able to read and write persian. Patients with pain related to treatment with doctor diagnosed , participant in other educational pain management program and with a history of cognitive, psychatric disorder were excluded this study.
Age
From 18 years old to 70 years old
Gender
Both
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciense
Street address
next to the red crescent street of zand
City
shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
791
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
pain intensity
Timepoint
befor intervetion, 2, 4 , 8 weeks after intervetion
Method of measurement
breif pain inventory
2
Description
quality of life
Timepoint
befor intervetion, 4 , 8 weeks after intervetion
Method of measurement
EORCT QLQ - C30 qestionnaire
Secondary outcomes
1
Description
pain satisfaction
Timepoint
befor intervetion, 2, 4 , 8 weeks after intervetion
Method of measurement
breif pain inverntory
2
Description
interfrence with daily function
Timepoint
befor intervetion, 2, 4 , 8 weeks after intervetion
Method of measurement
breif pain inventory
Intervention groups
1
Description
control group: patients in this group received routine clinical care.they complete The BPI questionnaire at the first interview, 2, 4 and 8 weeks after intervention and EORCT QLQ - C30 questionnaire complete before, 4 and 8 weeks after intervention.the control group recived relaxation CD and booklet consist of pain cancer management after intervention.
Category
Behavior
2
Description
experimental group:patients in this group compelet BPI and EORCT questionnaires. then recived education that consists of 6 session educational pain management in 20-30 minute during 6 week to addition of relaxation CD and booklet consist of pain cancer management. 2,4 and 8 weeks after interventin, their compelet questionnaires.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Unit in Nemazee Hospital _ Shiraz
Full name of responsible person
Hamideh Ansari Master of Sciense in Nursing
Street address
Shiraz ـ Nemazee Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciense
Full name of responsible person
Dr.Farkhondeh Sharif
Street address
Fatemeh Excellency Faculty of Nursing and Midwifery
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciense
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
Shiraz University of Medical Sciense
Full name of responsible person
Dr. Farkhondeh Sharif
Position
PhD of Psychiatry Nursing
Other areas of specialty/work
Street address
next to the red crescent street of zand
City
Shiraz
Postal code
Phone
+98 71 1626 6931
Fax
Email
fsharif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciense
Full name of responsible person
Dr. Farkhondeh Sharif
Position
PhD of Psychiatry Nursing
Other areas of specialty/work
Street address
next to the red crescent. street of zand
City
Shiraz
Postal code
Phone
+98 71 1626 6931
Fax
Email
fsharif@sums.ac.ir
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)