Investigation of the effect of intravenous catheterization and infusion orientation used by illustration on anxiety of hospitalized school-aged children in pediatric Emergency Department
The aim of this study is to determine the effects of intravenous catheterization and infusion orientation used by illustration on anxiety of hospitalized school-aged children in pediatric Emergency Department of Shohadaye Khalije Fars Hospital. This experimental research is a clinical trial in which 112 children ages 6-12 years are randomly brought into either intervention or control groups.
orientation is implemented through illustration by means of a booklet in which the procedure has been demonstrated fluently. After being visited by the doctor, the child accompanied by either parent will be entered the treatment room. Followed by 3 minutes waiting in the room, the child will be oriented by the procedure through the graphical booklet along with verbal explanation, if he belongs to the intervention group. But if he is in control group, the orientation will be limited to just verbal explanation (intervention phase) and then the procedure will be continued, both by the same nurse. Presence or absence of the 8 operational distress behavior mentioned in Observational Scale of Behavioral Distress (OSBD) will be recorded by the trained observer during the procedure at each phase and scored based on distress intensity. This study is divided into 4 phases in which the orientation will be executed between phases 1 and 2.
Phase 1: attending in waiting room for 3 minutes;
Phase 2: positioning injection site and skin cleaning;
Phase 3: intravenous catheterization and infusion procedure excecution;
Phase 4: from the end of phase 3 to 3 minutes after that.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041712830N22
Registration date:2017-05-29, 1396/03/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-29, 1396/03/08
Registrant information
Name
Faezeh Jahanpour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
f.jahanpour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Bushehr University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of intravenous catheterization and infusion orientation used by illustration on anxiety of hospitalized school-aged children in pediatric Emergency Department
Public title
The effect of intravenous catheterization and infusion orientation used by illustration on anxiety of children.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
• 6-12 years old;
• Informed Parental consent;
• Child assentation to participate in the research;
• first day of admit and first hospitalization;
• Child being accompany by either parent;
Exclusion criteria:
• Taking analgesic and anxiolytic drugs (at least 6 hours before procedure);
• Taking another nonpharmacological pain management method during procedure;
• Failure in first catheterization;
• Children with physical problems (verbal, mental, sight, hearing)
• Unconsciousness;
• Known psychological illnesses suffering;
• Needing for emergency vascular access.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
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 Bushehr University of Medical Sciences
Street address
No. 12, Bahmani, Yasini Avenue,Bushehr University of Medical Sciences Campus, Bushehr, Iran
City
Bushehr
Postal code
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.BPUMS.REC.1395.1
Health conditions studied
1
Description of health condition studied
Generalized anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Child anxiety
Timepoint
At each phase
Method of measurement
Observational Scale of Behavioral Distress
Secondary outcomes
empty
Intervention groups
1
Description
Control group: intravenous catheterization and infusion orientation by means of verbal explanation
Category
Behavior
2
Description
intravenous catheterization and infusion orientation by means of graphical booklet
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Khalije Fars Hospital
Full name of responsible person
Street address
City
Boushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,bushehr University of Medical Sciences
Full name of responsible person
Afshin Ostavar
Street address
NO 12, Campus of Medical Sciences,Bahamni, Yasini Avenue, Bushehr
City
Bushehr
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,bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Faeze Jahanpoor
Position
PhD in Nursing / Associate Professor
Other areas of specialty/work
Street address
NO 7, School of Nursing and Midwifery,Bahmani, Yasini st, Bushehr
City
Bushehr
Postal code
Phone
+98 33 3345 0178
Fax
Email
f.jahanpour@bpums.ac.ir; f_jahanpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Faeze Jahanpoor
Position
PhD in Nursing
Other areas of specialty/work
Street address
NO 7, School of Nursing and Midwifery,Bahmani, Yasini st, Bushehr
City
Bushehr
Postal code
Phone
+98 77 3345 0178
Fax
Email
f.jahanpour@bpums.ac.ir; f_jahanpour@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)