Children Requiring IV Placement Clinical Trial
Official title:
Distraction to Reduce Pain and Distress: A Randomized Controlled Trial of Children Undergoing Intravenous Placement in the Pediatric Emergency Department
Many medical procedures aimed at helping children can cause them pain and distress. If children have certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a very stressful place for children and their parents. There are also many procedures that children may have in the emergency department that can cause pain and distress. These include procedures such as needle pokes, stitches, or setting a broken bone. Two common methods of managing a child's pain in the emergency department are drugs and distraction. Drugs are not always practical and may come with unwanted side effects. Distraction is often used by parents or health professionals to help children deal with pain and stress. Distraction can lower the child's pain and distress by moving their attention from the painful experience, for example a needle poke, to a more positive feeling such as watching a movie, playing a game, or listening to music. This study will test if iPads are useful to help lower pain and distress for children (ages 6 to 11 years) who are visiting an emergency department and need an intravenous line put in. The results from this study could be important for many children receiving medical care, as distraction is safe and the use of iPads is enjoyable for many children.
Setting and Study Period: The study will be conducted in the ED of the Stollery Children's
Hospital. Patient recruitment is projected to begin in October 2014 and continue to March
2015.
Study Design and Population: The study will be a RCT; the primary outcomes will be the
child's self-reported pain and observed behavioural distress. The population is children,
ages 6 to 11 years, attending a pediatric ED and requiring IV placement.
Recruitment: Research assistants (RAs) will identify patients attending the ED between the
ages of 6 and 11 years. A RA will be on-site from approximately 14:00 to 22:00 daily to
identify children who require IV placement; this time corresponds with peak visits requiring
IV placements based on data collected in the ED at the Stollery Children's Hospital in team
members' previous studies. For those who require IV placement, the RA will further assess
child eligibility based on the inclusion / exclusion criteria outlined below. If the child is
eligible, the RA will explain the study and invite the parent and child to participate. After
obtaining written, informed consent from the parent and assent from the child, the RA will
open a prepared randomization envelope and assign the child to one of the two intervention
arms. The RA will ask one parent or caregiver for each child to participate and complete all
relevant questionnaires.
Baseline Assessment: After informed consent/assent is obtained, the RA will gather
information from the parent on baseline demographic variables (e.g., gender, age), presenting
signs and symptoms (e.g., chief complaint), and previous history with ED visits and IV
placement.
Randomization, Allocation, and Blinding of Study Treatment: Randomization method: A
statistician will prepare the randomization sequence using appropriate software and prepare
the envelopes. Allocation will be concealed from the RAs, ED staff, child and parent until
consent/assent has been obtained. The statistician will maintain the randomization code which
will not be broken until data analysis is complete. Allocation: After receiving informed
consent/assent, the RA will open the next envelope in a series of consecutively labeled,
sealed, opaque envelopes. These will be kept in a secured location in the ED research office.
Blinding: Due to the nature of the intervention, it will not be possible to blind the
children, parents, or research and ED staff. The children and their parents will be informed
that the study is to evaluate different forms of distraction but will not know the study
hypothesis for iPads nor what each group is receiving. The data analyst will be blind to
treatment assignment through the use of randomization codes that will not be disclosed until
analysis is complete.
Study Intervention and Comparison: The intervention will be the use of an iPad that will
include a selection of child-appropriate games. We will select popular, age-appropriate items
to include on the iPad, chosen based on the most current online consumer ratings. Children
and parents will be able to select their choice of distraction and can change their selection
as desired during the course of the procedure. These choices will be recorded for study
purposes. The control group will receive standard care, which generally includes the use of
topical anesthetic cream. This comparison is based on the pragmatic preferences of physicians
at the Stollery Children's Hospital as well as precedent in the literature. Overall, it is
felt that any new intervention (e.g., iPad) should be compared to what is currently in
practice (i.e., standard care), as no single distraction therapy is consistently and
routinely employed in EDs at this time.
Study Outcomes: The primary outcomes are patient pain and distress. Self-reported pain will
be measured using the Faces Pain Scale-Revised (FPS-R). This measurement will be made
immediately following the initial attempt at IV placement. The FPS-R is the currently
recommended pain scale for our participant group with strong evidence of validity and
reliability for our age range. Distress will be measured using the Observed Scale of
Behavioral Distress-Revised (OSBD-R); a tool designed to assess a child's behavioural
response to painful medical procedures. The scale scores are reliable and valid for our
target population. Two research students will be trained in the use of the tool and will
independently observe a videotape of each child and record the frequency of
operationally-defined distress-related behaviours during continuous 15-second intervals
before, during, and after the procedure. This protocol for use of the OSBD-R is standard; it
has been used in other trials evaluating distraction, including a trial by one of the PIs
(LH) evaluating music. The secondary outcomes are (a) observed pain which will be measured by
the research students using a standard 100 mm visual analogue scale; (b) parent and provider
satisfaction (measured using Likert scales); (c) ease of performing the procedure assessed by
the provider; time to complete the procedure; (d) success of the procedure; and (e) parent
state anxiety measured with a validated instrument, the State Trait Anxiety Inventory
(STAI-S, Form Y).
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Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04291404 -
Virtual Reality-based Distraction to Reduce Distress in the Pediatric Emergency Department
|
N/A | |
Completed |
NCT02997631 -
Robot-Based Distraction to Reduce Pain and Distress in the Pediatric Emergency Department
|
N/A |