Children Requiring IV Placement Clinical Trial
Official title:
A Randomized Controlled Trial of Humanoid Robot-Based Distraction for Venipuncture Pain: The MEDi Study
NCT number | NCT02997631 |
Other study ID # | Pro00068199 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 20, 2017 |
Est. completion date | May 13, 2018 |
Verified date | May 2018 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intravenous (IV) insertion is one of the most common procedures for children seeking medical
treatment in the Emergency Department (ED). This procedure is often painful and distressing
for children and families. This can result in an uncooperative child, a need for multiple
cannulation attempts, needle phobia, and dissatisfaction with care for family and healthcare
workers. Non-pharmacological treatments are emerging as a newly favoured adjunct to
pharmacotherapy, such as distraction therapy.
Distraction therapy involves engaging children in cognitive tasks in order to divert
attention from painful stimuli and reduce pain and distress. Currently, distraction therapy
is not utilized as a standard of care in the ED. Given children's enthusiasm for
technological devices, we propose that the use of a technologically enhanced device may be a
more effective distractor and may have a greater impact on pain reduction outcomes of patient
importance. The primary objective of this study is to compare the reduction of pain and
distress with the use of distraction (via the MEDi robot) versus current standard care in
children aged 6 to 11 years who are undergoing IV placement.
Status | Completed |
Enrollment | 86 |
Est. completion date | May 13, 2018 |
Est. primary completion date | May 13, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 11 Years |
Eligibility |
Inclusion Criteria: - 6 to 11 years of age - Needs an IV placement - Fully conscious and alert - Has sufficient knowledge of the English language to understand and complete the pain assessments - Accompanied by a legal guardian. Exclusion Criteria: - Hearing or visual impairments - Neurocognitive delays - Sensory impairment to pain (e.g., spina bifida) - Previous enrollment in the same study - Other exclusion at the discretion of the clinical staff |
Country | Name | City | State |
---|---|---|---|
Canada | Stollery Children's Hospital Emergency Department | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain of IV insertion | Pain scores will be self-reported by the child on the Faces Pain Scale-Revised (FPS-R) | <5 minutes before IV placement, and immediately after IV placement | |
Primary | Distress associated with IV insertion | Two RAs will independently observe a videotape of each child and use the Observational Scale of Behavioral Distress (OSBD) to assess children's response behaviors to pain. | During continuous 15-second intervals before, during, and after the IV placement procedure. Approximately 5 minutes before and after the procedure will be captured. | |
Secondary | Parental anxiety | Measured with the State Trait Anxiety Inventory - State Scale Revised Version (STAI-S, Form Y), a validated and commonly used version of STAI, which has improved psychometric properties | Immediately before and after IV placement | |
Secondary | Degree of child's engagement with robot | To determine a child's degree of engagement with the robotic technology, children, parents, and nurses will complete the 18-item version of the Intrinsic Motivation Inventory | Approximately 2-5 minutes after IV placement |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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