The impact of pain management education on acute pain severity in children (5-12y/o) with leukemia undergoing bone marrow aspiration in imam reza's hospital in Shiraz, Iran in 2012-2013
Designate the effect of pain management on acute pain in the pediatrics between 5-12 years old that have leukemia under bone arrow aspiration which go to imam reza's hospital in Shiraz, Iran.
Studding involves two groups (case and control). Population of studding: the pediatrics in the age between 5-12 that have leukemia under bone marrow aspiration. Sample's volume: 60 persons; at first, samples on the base of having the conditions for entering in study and select an easy method for sampling and after explaining the goal of study, take letting form; then the volunteers are divided in two groups in suddenly devotion method.The searcher in the time of studious will be present in that place. In this step each group will be under general case. Later, 30 and 60 minutes after doing the procedure the strength of pain by use of questionnaire for all volunteers will be determined the group of case and control. At the end, an informant booklet about disease and pediatric 's pain management will gave to their parents for studding during the first and the second aspiration. Then the date and the time of educational classes will be determined. Educational plan includes four section, 45 minutes theoretical and practical classes that contain speaking, practical and group's speaking which be done in groups with ten members for 4 weeks. Then the date and the time of second bone marrow aspirations will announced for the pediatrics and their parents.then the doctor will do the aspiration. 30 and 60 minutes after doing the procedure the number of pain severity with pain questionnaire for two groups, case and control, will be determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011512121N2
Registration date:2014-07-17, 1393/04/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-17, 1393/04/26
Registrant information
Name
Marziyeh Kargar Jahromi
Name of organization / entity
Fatemeh Holiness Nursing and Midwifery College
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
soodabeh.razmi@gmail.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-10-11, 1391/07/20
Expected recruitment end date
2013-08-06, 1392/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of pain management education on acute pain severity in children (5-12y/o) with leukemia undergoing bone marrow aspiration in imam reza's hospital in Shiraz, Iran in 2012-2013
Public title
The impact of pain management education on acute pain severity in children (5-12y/o) with leukemia undergoing bone marrow aspiration
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:the age of pediatric should be between 5 to 12 years old;pediatrics doesn't receive the pain management schedule;parents should fill letting form consciously and wants parents to seek the pediatrics idea in the procedure;the patient can do his/her exercise with diagnose of procedure doctor;6-pediatrics doesn't have any chronic disease.
Exclusion criteria: pediatrics or parents don't want to continue the project;unable to continue the exercise;absense in the educational class more than one time;the pediatrics needs to be in the hospital during the intervention.
Age
From 5 years old to 12 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
Ethics Committee Of Shiraz University Of Medical Science
Street address
Shiraz University of Medical Science,Zand Ave.,Shiraz,Iran
City
Shiraz
Postal code
14336-71348
Approval date
2012-12-13, 1391/09/23
Ethics committee reference number
CT-91-6340
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 2 month after intervention and in both stage before, 30 and 60 minute after doing procedure
Method of measurement
Oucher scale
Secondary outcomes
empty
Intervention groups
1
Description
in case group education is about desease,medical management of pain and non medical management of pain that contain distraction,relaxation.this contain educate to patient in 4 section in 1 month and a educational book give to them.in control group we don't anything of this and in the end of the investigation all of this contaain educate to control group
Category
Behavior
2
Description
in control group we don't anything of this(distraction,relaxation &educational book don't give to them and in the end of the investigation all of this contaain educate to control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Poly Clinic
Full name of responsible person
Marziyeh Kargar
Street address
Imam Reza Poly Clinic,Namazi Square, Shiraz,Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research,Shiraz University Of Medical Science
Full name of responsible person
Gholamreza Hatam
Street address
ShirazUniversity Of Medical Sciences,Zand st.,shiraz,Iran
City
Shiraz
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,Shiraz University Of Medical Science
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
Marziyeh Kargar
Position
Master of Nursing/Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Namazi Square,Shiraz,Iran
City
Shiraz
Postal code
13119-71936
Phone
+98 71 1647 4254
Fax
Email
kargarm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Marziyeh Kargar
Position
Master of Nursing/Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Namazi Square,Shiraz,Iran
City
Shiraz
Postal code
Phone
+98 71 1647 4254
Fax
Email
kargarm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Soodabeh Razmi
Position
Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery,Namazi Square,Shiraz,Iran
City
Shiraz
Postal code
71936-13119
Phone
+98 71 1647 4254
Fax
Email
soodabeh.razmi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)