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Influence of Virtual Reality on catheterization pain control in 6-12 years old patients

Protocol summary

Summary
This study aims to provide a drug-free, easy and effective way to control the pain caused by catheterization in children. Inclusion criteria: children aged 12-6 years candidate for getting catheter. Exclusion criteria: history of hospitalization and IV received analgesics before catheterization, refractive vision problems (astigmatism, lens and glasses ...), and the experience of virtual space, agitated, critically ill and toxic children with special status, and unconsciousness. Totally, 126 children will participate in both the intervention and control groups. After collecting the samples, the informed consent form will be obtained from the child's guardian. Two minutes before venipuncture, virtual space is used to familiarize children and this process continues until end. The time of venepuncture will be calculated from arrival of needle to IV fixation. 10 minutes after the process, we would ask participants to explain their pain experience during venepuncture using the Oucher and select a picture shows the amount of pain. In the control group, all of the steps will be implemented except the virtual space.

General information

Acronym
Virtual Reality - VR
IRCT registration information
IRCT registration number: IRCT201211204490N2
Registration date: 2012-12-17, 1391/09/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-12-17, 1391/09/27
Registrant information
Name
Mohadese Babaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
hadisbabaie@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of Virtual Reality on catheterization pain control in 6-12 years old patients
Public title
catheterization pain control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian children aged 12-6 years candidate for getting catheter. Exclusion criteria: history of hospitalization and IV received analgesics before catheterization; refractive vision problems (astigmatism, lens and glasses ...); the experience of virtual space; agitated, critically ill and toxic children with special status, and unconsciousness.
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: 124
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Qazvin University of Medical Sciences
Street address
Shahid Bahonar boulevard
City
Qazvin
Postal code
Approval date
2012-10-29, 1391/08/08
Ethics committee reference number
28/20/6507

Health conditions studied

1

Description of health condition studied
control the pain caused by catheterization
ICD-10 code
Z51.9
ICD-10 code description
Medical care, unspecified

Primary outcomes

1

Description
pain caused by catheterization
Timepoint
10 minutes after the catheterization
Method of measurement
Oucher scale (Faces Pain Scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: Two minutes before venipuncture, virtual space is used to familiarize children and this process continues until end.
Category
Prevention

2

Description
Control: no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Qods hospital in Qazvin
Full name of responsible person
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeid Asefzade
Street address
Shahid Bahonar boulevard
City
Qazvin
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, Qazvin 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
Nursing and Midwifery department, Qzvin University of Medical Sciences
Full name of responsible person
Mohadese Babaie
Position
Nursing student
Other areas of specialty/work
Street address
Shahid bahonar boulevard
City
Qazvin
Postal code
Phone
+98 28 1333 7006
Fax
Email
hadisbabaie@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing and Midwifery department, Qzvin University of Medical Sciences
Full name of responsible person
Mehdi Hosseini
Position
Nurse
Other areas of specialty/work
Street address
Shahid Bahonar boulevard
City
Qazvin
Postal code
Phone
+98 28 1333 7006
Fax
Email
mehos2007@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mehdi Hosseini
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
mehos2007@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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