Children Requiring IV Placement Clinical Trial
Official title:
A Randomized Controlled Trial of Virtual Reality-based Distraction for Venipuncture-related Distress in Children
Verified date | October 2021 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Needle procedures, such as intravenous (IV) insertions, are among the most commonly performed procedures for children needing medical care. IV insertions are often a painful and stressful experience for both children and their parents/ caregivers. Pediatric pain and distress that is not adequately treated may lead to a frightened and uncooperative child, repeated IV attempts and overall frustration with care for the family and clinical team. Distraction therapy is a common psychological strategy which involves engaging children in a cognitive task or activity in order to divert attention away from painful stimuli. Given children's growing enthusiasm for novel technology, the investigators propose that an immersive virtual reality (VR) experience may provide an effective means of distraction for children undergoing IV insertions.
Status | Completed |
Enrollment | 84 |
Est. completion date | February 12, 2022 |
Est. primary completion date | February 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | We will include children presenting to the Stollery Children's Hospital ED, based on the eligibility criteria outlined below: Inclusion Criteria: 1. child aged 6-17 years 2. requires IV placement 3. will receive topical anesthetic cream for IV placement Exclusion Criteria: 1. medically unstable (CTAS 1, requires immediate IV insertion) 2. unconscious or not fully alert 3. visual, auditory or cognitive or mental health issues precluding safe interaction with the VR intervention 4. conditions that could be exacerbated by the VR environment (as reported by the family), such as: (i) current symptomatic nausea / vomiting / dizziness / migraine; (ii) history of psychosis / hallucinations / epilepsy 5. presence of an infection / injury which could contaminate the VR intervention equipment (as determined by the healthcare team) including but not limited to: (i) open wounds / infections of the head and neck area; (ii) suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA) colonization 6. screens positive for 'influenza-like illness' (ILI) as per the current SCH ED screening criteria 7. child or parental language barrier precluding the ability to understand and complete study assessments, in the absence of a native language translator 8. previous enrollment in this study |
Country | Name | City | State |
---|---|---|---|
Canada | Stollery Children's Hospital | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Child's total distress score during the IV procedure | Two RAs will independently observe a videotape of each child and use the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess children's response behaviors to pain. (0 = no distress, 23.5 = maximum distress) | During the IV placement procedure | |
Secondary | Child's pain score during the IV procedure | Self reported by child using an 11-point verbal Numerical Rating Scale (vNRS) ranging from 0, which indicates no pain, to 10, which indicates the worst possible pain | Immediately after IV placement | |
Secondary | Child's Fear | Self reported by child using the Children's Fear Scale (CFS). This is a five face scale ranging from 0= not scared at all to 4= most scared possible. | Immediately after IV placement | |
Secondary | Parental anxiety | Parent will fill out 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. The score ranges from 20 to 80, with 80 indicating maximum anxiety. | Immediately after IV placement | |
Secondary | Parent/ Caregiver Satisfaction | Self-reported using a 5-point likert scale, ranging from 1 "Not at all satisfied" to 5 "Very satisfied". | Immediately following the IV procedure | |
Secondary | Nurse Satisfaction | Self-reported using a 5-point likert scale, ranging from 1 "Not at all satisfied" to 5 "Very satisfied". | Immediately following the IV procedure | |
Secondary | Child Satisfaction | For children, we will use a a 5-point likert scale ranging from 1 "Not at all happy" to 5 "Very happy". | Immediately following the IV procedure | |
Secondary | Frequency of adverse events related to the study intervention | Determined by assessing the frequency of adverse events post intervention. Nausea will be self-rated by children immediately following the intervention, using the Baxter Retching Faces (BARF) scale. This is a six face scale ranging from 0= no nausea at all to 10= most nausea it is possible to feel. | During the IV procedure | |
Secondary | Child's distress during the IV procedure | In addition to assessing child distress via the Observational Scale of Behavioral Distress - Revised (primary outcome), we will also ask children to self-report their distress on an 11-point numerical rating scale ranging from 0 "no distress" to 10 "the most distress you can imagine having". While easy to use and previously employed, this scale has not been validated or compared to the validated Observational Scale of Behavioral Distress - Revised. | Immediately after IV placement |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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