Research with human participants

Overview of medical research in the Netherlands

The effect of Virtual Reality as a source of information on anxiety, pain and patient sattisfaction in children that need to undergo an Intravenous catheterplacement.

Published:
Last updated:

In a randomised setting we want to investigate wheter we can reduce anxiety and pain in children that need an IV catheter by using a 360 Virtual Reality video in preparation of the actual needle placement.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Observational non invasive

ID

NL-OMON46620

Source

ToetsingOnline

Brief title

Infor-Prick

Condition

  • Other condition

Synonym

No specific condition besides need for intravenous infusion. Anxiety and pain are assessed

Health condition

Geen specifieke aandoening. Kinderen die een infuus gaan krijgen. Angst en pijnbeleving worden gemeten

Research involving

Human

Sponsors and support

Primary sponsor :
Chirurgie
Source(s) of monetary or material Support :
geen geldstroom. video beelden en apparatuur worden uitgeleend

Intervention

Keyword :
Anxiety reduction, Children, Patient preparation, Virtual Reality

Outcome measures

Primary outcome

Anxiety reduction on the Children's Fear Scale

Secondary outcome

Anxiety on ZBV-K and GDRS

Pain

patient sattisfaction

time needed for actual needle placement

Background summary

For children application of an IV catheter can lead to anxiety and pain.

Study objective

In a randomised setting we want to investigate wheter we can reduce anxiety and
pain in children that need an IV catheter by using a 360 Virtual Reality video
in preparation of the actual needle placement.

Study design

Randomised controlled trial single blinded. In hospital on daycare.

Study burden and risks

None besides the theoretical provocation of anxiety

Public
Selecteer

de Run 4600
Veldhoven 5504DB
NL
Scientific
Selecteer

de Run 4600
Veldhoven 5504DB
NL

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Children (2-11 years)

Inclusion criteria

Children aged 6 -16 years old that need an intravenous catheter placement

Exclusion criteria

Previous Iv catheter placement in past 6 months
Serious psychological disorder
Anxiety disorder
Mental disorder
Little knowledge of Dutch language, both for patient and parent
Need to use dormicum or nitrous oxide during the procedure
Visual disorder
Epilepsy

Design

Study type :
Observational non invasive
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Primary purpose :
Other

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
100
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Maxima Medisch Centrum (Veldhoven)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 27571
Source: NTR
Title: The effect of Virtual Reality as an information tool on anxiety, pain and patient satisfaction in children undergoing intravenous infusion.

In other registers

Register ID
CCMO NL64002.015.17
OMON NL-OMON27571