Comparison effect of two methods of distraction with playing dough and bubbles making on Pain Intensity during venipuncture in 3-6 age children in pediatric emergency department and parental satisfaction
The aim of this study is comparing the effect of playing dough and bubbles making on pain intensity during venipuncture in children and parental satisfaction. Inclusion Criteria: informed consent for participation in the study; children who have been admitted for the first time; presence of a parent; lack of any visible growth retardation and inability; lack of chronic diseases; lack of severe pain before intervention; aged between 3-6 years; lack of narcotic addiction; lack of taking narcotic analgesics drugs, sedatives and analgesics drugs in 24 hours before venipuncture; lack of history of previous hospitalization and venipuncture. Exclusion Criteria: discard from continuance of the study for any reason; severe pain during the intervention. This study is a randomized clinical trial with three- groups of 90 children 3-6 years old referring to pediatric emergency department of Ghaem and Dr Sheikh and Imam Reza hospitals of Mashhad. Sampling was conducted via convenience sampling method and participants randomly divided into three groups (play dough group, bubble blowing group and control). Then the children who were in play dough group were encouraged by the help of researcher to play dough and make figures five minutes before venipuncture to the end of venipuncture process, and also the bubble blowing group children were persuaded to bubble blowing just 5 minutes before venipuncture to the end of it. The Control group received the warden common procedure. Each of the three mentioned groups were asked to announce the level of their pain using Wong-Baker (FACES) Pain Rating Scale 10 minutes after the venipuncture procedure. In addition, the parental satisfactions, were measured by the researcher-made questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030621349N1
Registration date:2015-06-03, 1394/03/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-03, 1394/03/13
Registrant information
Name
zahra sajjadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3722 9666
Email address
sajjadiz921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-03-30, 1394/01/10
Expected recruitment end date
2015-05-31, 1394/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of two methods of distraction with playing dough and bubbles making on Pain Intensity during venipuncture in 3-6 age children in pediatric emergency department and parental satisfaction
Public title
Effect of distraction on Pain during venipuncture
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: informed consent for participation in the study; children who have been admitted for the first time; presence of a parent; lack of any visible growth retardation and inability; lack of chronic diseases; lack of severe pain before intervention; aged between 3-6 years; lack of narcotic addiction; lack of taken of narcotic analgesics drugs, sedatives and analgesics drugs in 24 hours before venipuncture; lack of history of previous hospitalization and venipuncture. Exclusion Criteria: discard from continuance of the study for any reason; severe pain during the intervention.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Mashhad University of Medical Sciences
Street address
Mashhad Faculty of Nursing and Midwifery,Ebn-e Sina St, Doktora Crossing, Daneshgah Ave.
City
Mashhad
Postal code
Approval date
2015-02-23, 1393/12/04
Ethics committee reference number
research/930949/1/372
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 Intensity during venipuncture
Timepoint
10 minutes after the venipuncture
Method of measurement
by using the Wong-Baker (FACES) Pain Rating Scale
Secondary outcomes
1
Description
Parental satisfaction
Timepoint
After the venipuncture
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
The children who were in play dough group were encouraged by the help of researcher to play dough and make figures five minutes before venipuncture to the end of venipuncture process.
Category
Behavior
2
Description
The bubble blowing group children were persuaded to bubble blowing just 5 minutes before venipuncture to the end of it. .
Category
Behavior
3
Description
The Control group received the warden common procedure (talking a nurse with the child to calm her during venipuncture).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Emergency Department , Dr Shaikh Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Shahrokh Maghsoudi
Street address
Mashhad Faculty of Nursing and Midwifery,Ebn-e Sina St, Doktora Crossing.
City
Mashhad
2
Recruitment center
Name of recruitment center
Pediatric Emergency Department,Ghaem Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Shahrokh Maghsoudi
Street address
Mashhad Faculty of Nursing and Midwifery,Ebn-e Sina St, Doktora Crossing.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Building Qureshi,Ebn-e Sina St, Mashhad
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Sajjadi
Position
Master of Science student in pediatric Nursing
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery,Ebn-e Sina St, Doktora Crossing.
City
Mashhad
Postal code
Phone
+98 58 3722 9666
Fax
Email
SajjadiZ921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Shahrokh Maghsoudi
Position
Master of Science in Nursing,Faculty member of School of Nursing and Midwifery, Mashhad
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery,Ebn-e Sina St, Doktora Crossing.
City
Mashhad
Postal code
Phone
+98 58 3722 9666
Fax
Email
MaghsoudiSh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Sajjadi
Position
Master of Science student in pediatric Nursing
Other areas of specialty/work
Street address
Mashhad Faculty of Nursing and Midwifery,Ebn-e Sina St, Doktora Crossing.
City
Mashhad
Postal code
Phone
+98 58 3722 9666
Fax
Email
sajjadiz921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)