The present research is on the effect of doll injection display on the intensity of anxiety and pain due to intramuscular injection in pre-school children. The present study is a clinical experimental and double blind. The research sample consists of 50 children suffering pharyngitis that aged 4-6 years old and need intramuscular injection of penicillin 6.3.3. The participants were randomly divided into two groups (experimental group and one control group). The instruments used in the research include: demographic Information questionnaire, the Scale of facial self-report of anxiety and pain questionnaire Usher. Before intramuscular injection on the samples in the experimental group, intramuscular injection was done on a doll by a nurse. Anxiety of patients before and after the intervention and pain was measured after intervention. The analysis of the data was carried out through SPSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070623103N1
Registration date:2015-07-26, 1394/05/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-26, 1394/05/04
Registrant information
Name
Mostafa Zivari
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 2395
Email address
zivari.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2015-03-10, 1393/12/19
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of doll injection display on the intensity of anxiety and pain due to intramuscular injection in pre-schoo children
Public title
The effect of doll injection on pain and anxiety of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children 4 to 6 years old; parental consent to participate in research; accompanied by a parent; children with pharyngitis disease following injections of the drug as directed by physician groups have penicillin; no intramuscular injection in the last week; lack of acute and chronic pain due to other factors in the body; lack of physical disability; lack of chronic disease; not taking medications that reduce anxiety; taking medications that reduce pain; is able to communicate
Exclusion criterion: patient not cooperate with the therapist.
Age
From 4 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Almahdi St.
City
Gonabad
Postal code
9691793718
Approval date
2015-03-10, 1393/12/19
Ethics committee reference number
IR.GMU.REC.1394.19
Health conditions studied
1
Description of health condition studied
Pharyngitis
ICD-10 code
J02,9
ICD-10 code description
Pharyngitis, Acute or NOS
Primary outcomes
1
Description
Pain
Timepoint
After intervention
Method of measurement
Oucher questionnaire
2
Description
Anxiety
Timepoint
Before and after the intervention.
Method of measurement
Self-report questionnaire Piyeri
Secondary outcomes
1
Description
Age
Timepoint
Before intervention
Method of measurement
Questionnaire
2
Description
Gender
Timepoint
Before intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group; in this group before Intramuscular injection of penicillin 6.3.3 on the child, once intramuscular injection (similar to the actual injection) is done on the doll and the child will see this action, then intramuscular injection is done on the child.
Category
Other
2
Description
Control group; in this group intramuscular injection of penicillin 6.3.3 routinely is done on the child.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Health Network Khalil Abad
Full name of responsible person
Mr. Khazaee
Street address
Imam Khomeini St.
City
Khalil Abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghadimi
Street address
Gonabad University of Medical Sciences, Almahdi St.
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Afsharnya
Position
PhD Environmental Health / Management Education
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Almahdi St.
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 5080
Fax
+98 51 5722 3814
Email
WWW.GMU.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Irani Hassan
Position
Master's Degree in Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Almahdi St.
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 5080
Fax
+98 51 5722 3814
Email
www.gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mostafa Zivari
Position
MSc Nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Almahdi St.
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 5080
Fax
+98 51 5772 7315
Email
zivari.m@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)