Comparison of two methods of deep breathing and computer games on pain caused by intravenous injections in school age children with leukemia
Design
A randomized, double blinded clinical trial with three equal parallel groups. The sample size will be 90.
Settings and conduct
This double blind study Will be performed on 90 6-12 year old patients with leukemic at Dr.Sheikh Hospital in Mashhad. Blinding is done for participants, principal researcher, clinical care giver and statistician. Patients are divided into three equal groups: control, deep breathing and computer game groups.The pain in all three groups of children will be measured before and after injection and the results will be evaluated by the researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of leukemia by oncologist at least 6 months ago; Children aged 6-12 years old; Not having acute pain; Being alert to time and place; Not using pain medications from 24 hours before injection. Non-inclusion criteria: Failure of first attempt by the nurse to inject children; Cardiovascular and respiratory disorders; Mentally retarded child; Possible child death.
Intervention groups
Intervention group 1: Deep breathing technique was performed by the child 1 minute before injection till 1 minute after the procedure. The pain of children was assessed by the researcher every 30 seconds using Wang-Baker pain scale.
Intervention group 2: the children in the computer group played Angry Birds game then children started to play the game three minutes before the injection till to three minute after the injection.The pain of children was assessed by the researcher every 30 seconds by Wang-Baker scale.
Control group: the pain of children was assessed 3 minutes before the injection till 3 minutes after it by the researcher using Wong _ Baker Scale every 30 minutes.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171015036790N2
Registration date:2019-01-29, 1397/11/09
Registration timing:retrospective
Last update:2019-01-29, 1397/11/09
Update count:0
Registration date
2019-01-29, 1397/11/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51342616072
Email address
marsamiri@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
personal
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of deep breathing and computer games on pain caused by intravenous injections in school age children with leukemia
Public title
Effect of deep breathing and computer games on pain caused by intravenous injection in children with leukemia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of leukemia by oncologist at least 6 months ago
Children aged 6-12 years old
Not having acute pain during the vessel puncturing
Being alert to time, place and person
Need to have an intravenous line
Do not use pain medications from 24 hours before the vessel is inserted
At least one parent should be with child
There is no problem for handheld computer games
Lack of mental retardation
Exclusion criteria:
Children in whom first attempt has been failed by the nurse
Cardiovascular and respiratory disorders
not cooperating child
Mentally retarded child
Possible child death
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into one of the deep breathing intervention groups (A), computer-controlled intervention (B) and control (C) by lottery.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind , so that the participants, principal researcher, clinical care giver and data analyzer are not aware of the allocation of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Medical Sciences of Tehran
Street address
Islamic Azad University Medical Sciences of Tehran، Khaghani Avenue, Shariati St.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2017-11-07, 1396/08/16
Ethics committee reference number
IR.IAU.TMU.REC.1396.183
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukaemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia [ALL]
Primary outcomes
1
Description
pain
Timepoint
In the intervention group with deep breathing, the child's pain will be measured from 1 minute before the incision until 1 minute after the incision every 30 seconds. In the intervention group with computer games, the child's pain will be measured from 3 minutes before the incision until 3 minutes after the incision every 30 seconds. In the control group, the child's pain will be measured from 3 minutes before the incision until 3 minutes after the incision every 30 seconds.
Method of measurement
Vang-Baker pain measurement scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: 30 children are randomly allocated to this group. Then Hey_Hu technique is taught to the patients before injection.In this method,at first the child takes a deep breath ,exhales while exhales whispering hey. Then he/she inhales deeply again and exhales whispering hu. This is practiced by the child in the order to implement it accurately and is performed 1 minute before till 1 minute after the procedure. The pain of children will be assessed by wong_Baker Pain Measurement Scale every 30 seconds by the researcher.
Category
Prevention
2
Description
Second intervention group: In this group, 30 children are randomly allocated. The children in the hand _held computer group play Angry Birds game. Then children start to play the game 3 minutes before the injection till 3 minutes after the procedure. The pain of children will be assessed by Wong_Baker pain Measurement Scale every 30 second by the researcher.
Category
Prevention
3
Description
Control group: In this group ,30 children are randomly allocated. Then the nurse does the injection through routine procedure. The pain of children will be assessed 3 minutes before the injection till 3 minutes after the injection by Wong_Baker Pain Measurement Scale every 30 second by the researcher.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Mersa Sadat Miri
Street address
Dr. Sheikh Children's Hospital،Taheri Street،Tohid square
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Fax
Email
Sheikh.Hos@mums.ac.ir
Web page address
http://sheikh.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Bijan Ranjbar
Street address
Seventh Floor،Third Block، Central building of Islamic Azad University, Daneshgah square, Shohaday Hesarak blvd
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
Email
info@rvp.iau.ir
Web page address
http://www.rvp.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mersa sadat Miri Jagharq
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Street address
No 130, Behvarz 4, Janbazan Blvd
City
Neyshabour
Province
Razavi Khorasan
Postal code
9193863397
Phone
+98 51 4261 6072
Fax
Email
marsamiri@iautmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Medical Branch, Islamic Azad University
Full name of responsible person
Fatemeh Alaei Karahroodi
Position
P.H.D
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Tehran Medical Branch, Islamic Azad University, Khaghani St , Shariati St
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Fax
Email
falaeekarahroudy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mersa Sadat Miri Jagharq
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Street address
No 130, Behvarz 4, Janbazan Blvd
City
Neyshabour
Province
Razavi Khorasan
Postal code
9193863397
Phone
+98 51 4261 6072
Fax
Email
marsamiri@iautmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
This form contains questions about the degree of childbirth, the duration of the disease, the frequency of admission, the type of cancer, the organs used, the vein used, for example, metacarpal, cephalic, acyclic, intravenous injection, angioquist size, maternal education.
When the data will become available and for how long
Start the access period 6 months after printing the results