Protocol summary

Summary
Cancer patients experience of physical and psychological symptoms and distress that pain is one of the most important. Pain causing harmful negative effects on mood, functional status and quality of life. .One important component of cancer treatment is palliative care Palliative care is a set of measures aimed at improving the quality of life for patients and their families, to solve the problems of refractory and life-threatening diseases by preventing or eliminating the pain, with early detection, assessment and treatment of pain and full mental problems - is a psychological and physiological. One of the most common barriers to pain management, inadequate pain assessment and inadequate knowledge about pain management, one of the approaches to palliative care for cancer patients is education. The present study is a clinical trial to evaluate the effect of teaching of pain palliative care on the pain management in cancer patients. In this study, 98 cancer patients admitted to hospitals of Arak University of Medical Sciences are screened by the Brief Pain Inventory screened and selected on the type available and randomly will be divided into control and intervention groups. Teaching of palliative care will be for 20 minutes daily for 6 days. Brief Pain Inventory and pain experience scale in the first phase, then the third-Six weeks after the end of teaching sessions will be filled out in order to assess the impact of interventions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403122226N14
Registration date: 2014-04-19, 1393/01/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Mansooreh Aliasgharpour
Name of organization / entity
Nursing & midwifery faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
aliasgha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-05-05, 1393/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of teaching of pain palliative care on the pain management in cancer patients
Public title
Effect of teaching of pain palliative care on the pain management in cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: ranging in age from 18 to 65 years old; confirmed diagnosis of cancer; having 4 or higher pain using the Brief Pain Inventory; able to speak and understand the speech of others. Exclusion criteria: if the patient previously or concurrently enrolled in a teaching program in pain management or physical or psychological or psychiatric problems are severe; patients with invasive treatments for pain, such as subcutaneous or intravenous infusion of opioids they received; the patient's unwillingness to continue the study; failure to attend meetings and patient's death.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 nursing&midwifery Tehran University of Medical Sciences
Street address
nursing&midwifery facultyTehran University of Medical Sciences- squar toohid -tehran-iran
City
tehran
Postal code
1419733171
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93-01-28-25022

Health conditions studied

1

Description of health condition studied
Neopelasm
ICD-10 code
C00-D48
ICD-10 code description
Neopelasm

Primary outcomes

1

Description
Reducing pain and increasing patient knowledge after teaching
Timepoint
Before intervention, the end of the 3th week and 6th week
Method of measurement
Pain Experience Scale, Brief Pain Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Brief Pain Inventory and pain experience scale in the first phase, then the third-Six weeks.
Category
Treatment - Other

2

Description
Intervention group: Teaching of palliative care will be for 20 minutes daily for 6 days. Brief Pain Inventory and pain experience scale in the first phase, then the third-Six weeks after the end of teaching sessions will be filled out in order to assess the impact of interventions
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
fahimeh davodabady
Street address
motahari 1 st, ghaem magham st
City
arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Tehran University of Medical Sciences , Ghods street, Keshavarse bulvar, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
MSc student of nursing
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Tehran University of Medical Sciences- Toohid Square- Tehran- Iran
City
Tehran
Postal code
Phone
Fax
Email
fahimedavodabady@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgarpoor
Position
MSc
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Tehran University of Medical Sciences- Toohid Square- Tehran- Iran
City
Tehran
Postal code
Phone
Fax
Email
aliasgha@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgarpour
Position
Faculty member
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Tehran University of Medical Sciences- Toohid Square- Tehran- Iran
City
Tehran
Postal code
Phone
+98 21 6105 4327
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...