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
NCT number | NCT02326623 |
Other study ID # | Pro00050791 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | July 30, 2018 |
Verified date | February 2017 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | July 30, 2018 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 11 Years |
Eligibility |
Inclusion Criteria: - attending pediatric emergency department - require IV placement - fully conscious and alert - have sufficient knowledge of the English language to understand and complete the pain assessments Exclusion Criteria: - hearing or visual impairments - neurocognitive delays - sensory impairment to pain (e.g., spina bifida) - at the discretion of the attending staff (e.g., child in critical condition) |
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 | pain (self report) Faces Pain Scale-Revised (FPS-R) | Faces Pain Scale-Revised (FPS-R) | at time of IV placement, Day 1 | |
Primary | distress Observed Scale of Behavioral Distress-Revised (OSBD-R) | Observed Scale of Behavioral Distress-Revised (OSBD-R) | at time of IV placement, Day 1 | |
Secondary | pain (observed) visual analogue scale | measured by the research students using a standard 100 mm visual analogue scale | at time of IV placement, Day 1 | |
Secondary | parent and provider satisfaction (Likert scale) | Likert scale | 2 minutes post IV placement, Day 1 | |
Secondary | ease of procedure performance (assessed by provider) | assessed by provider | at time of IV placement, Day 1 | |
Secondary | success of procedure (assessed by provider) | assessed by provider | at time of IV placement, Day 1 | |
Secondary | parent anxiety (State Trait Anxiety Inventory (STAI-S, Form Y) | State Trait Anxiety Inventory (STAI-S, Form Y) | at time of IV placment, Day 1 |
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 |