Distraction to Reduce Pain and Distress in the Pediatric Emergency Department

NCT02326623 | Completed

• 1 other identifier: Pro00050791
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children Requiring IV Placement

Outcome Measures

Primary Outcomes (2)

• pain (self report) Faces Pain Scale-Revised (FPS-R)

  Faces Pain Scale-Revised (FPS-R)

  at time of IV placement, Day 1

• 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 Outcomes (5)

• pain (observed) visual analogue scale

  at time of IV placement, Day 1

• parent and provider satisfaction (Likert scale)

  2 minutes post IV placement, Day 1

• ease of procedure performance (assessed by provider)

  at time of IV placement, Day 1

• success of procedure (assessed by provider)

  at time of IV placement, Day 1

• parent anxiety (State Trait Anxiety Inventory (STAI-S, Form Y)

  at time of IV placment, Day 1

Study Arms (2)

iPad distraction

EXPERIMENTAL

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.

Other: distraction

standard care

OTHER

The control group will receive standard care, which generally includes the use of topical anesthetic cream.

Other: topical anesthetic cream

Interventions

distraction OTHER

distraction using an iPad with a selection of child-appropriate games

iPad distraction

topical anesthetic cream OTHER

standard care is to use a topical anesthetic cream at the site of planning IV access

standard care

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2L9, Canada

Location

Related Publications (1)

• Ali S, Ma K, Dow N, Vandermeer B, Scott S, Beran T, Issawi A, Curtis S, Jou H, Graham TAD, Sigismund L, Hartling L. A randomized trial of iPad distraction to reduce children's pain and distress during intravenous cannulation in the paediatric emergency department. Paediatr Child Health. 2020 Aug 20;26(5):287-293. doi: 10.1093/pch/pxaa089. eCollection 2021 Aug.

  PMID: 34630780 DERIVED

MeSH Terms

Interventions

Osteogenesis, Distraction

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Samina Ali, MD

  University of Alberta/Stollery Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2014
• First Posted: December 29, 2014
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: July 30, 2018
• Last Updated: August 1, 2018

Record last verified: 2017-02

Locations

CA (1)