Abstruct:
The present study will be designed and conducted to determine the effect of video game play on pain of venipuncture in 3-6 year-old children.This randomized controlled trial study will be conducted on 80 hospitalized children with pain of venipuncture procedures. Playing a video computer game for children during the venipuncture procedures was the intervention for the interventional group. Also the intensity of pain was measured by behavioral pain scale for children (FLCC scale) during the procedure. This scale will be completed for patients without any intervention in the control group during venipuncture procedures. it seems that video game play intervention has a significant positive effect on the pain of venipuncture procedures in children. Further studies are recommended for the development of this technique in health care centers.
Key Words: Distraction, Pain, venipuncture procedure, Children.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016032625029N3
Registration date:2016-05-05, 1395/02/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-05, 1395/02/16
Registrant information
Name
Sima Kaheni
Name of organization / entity
Faculty of nursing and medvifry, Mazandaran University of Medical Sciences, Sari, Iran
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
s.kaheni@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Mazandaran University of Medical Sciences
Expected recruitment start date
2016-03-29, 1395/01/10
Expected recruitment end date
2016-04-29, 1395/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Distraction Technique on Pain of Venipuncture in 3-6 Year-old Children
Public title
The Effect of Distraction Technique on Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: were the age of child 3-6; alertness to place; time and person; having the ability to communicate; not having verbal and auditory disorders; the presence of a parent with the child.
excluded criteria:event of a life-threatening emergency
Age
From 2 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Mazandaran University of Medical Sciences
Street address
Moalem Square
City
Sari
Postal code
4816715793
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.MAZUMS.REC.94-1806
Health conditions studied
1
Description of health condition studied
Pain of Venipuncture
ICD-10 code
Z40,Z41,Z4
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
Pain
Timepoint
Before and during the intervention
Method of measurement
Flacc Scale
Secondary outcomes
empty
Intervention groups
1
Description
For the interventional group, 3 minutes before the venipuncture procedures, distraction started by displaying a game on a portable monitor and continued until the end of venipuncture procedures
Category
Other
2
Description
in the control group, venipuncture procedures was done without any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Hospital
Full name of responsible person
ُSima Kaheni
Street address
Imam square
City
ُSari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moalem square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Sima Kaheni
Position
Master degree/Facultymember
Other areas of specialty/work
Street address
School of Nursing and Midwifery Nusseibeh
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
S.kaheni@mazums.ac.irkaheni20122yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masou Bagheri nesami
Position
Phd/Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery Nusseibeh
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
mbagheri@mazums.ac.iranna3043@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sima Kaheni
Position
Master degree/Faculty member
Other areas of specialty/work
Street address
Nusibeh Nursing and Midwifey faculty
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
S.kaheni@mazums.ac.irkaheni2012@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)