Robot-Based Distraction to Reduce Pain and Distress in the Pediatric Emergency Department

NCT02997631 | Completed

• 1 other identifier: Pro00068199
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children Requiring IV Placement

Keywords

Pain Management; Distraction Therapy; Robot Based Distraction; MEDi

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Parental anxiety

  Immediately before and after IV placement

• Degree of child's engagement with robot

  Approximately 2-5 minutes after IV placement

Study Arms (2)

MEDi Distraction

EXPERIMENTAL

The intervention will be the use of the MEDi robot. The robot will be at the child's eye level, and will be programmed to introduce itself, interact with the child, and make encouraging comments about how brave he/she was. The duration of its actions will coincide with the length of the procedure (approximately 5-8 minutes).

Device: MEDi Robot

Standard Care

NO INTERVENTION

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., the MEDi robot) 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.

Interventions

MEDi Robot DEVICE

Distraction therapy using an interactive humanoid robot

MEDi Distraction

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Hearing or visual impairments
• Neurocognitive delays
• Sensory impairment to pain (e.g., spina bifida)
• Previous enrollment in the same study

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Stollery Children's Hospital Emergency Department

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

• Ali S, Manaloor R, Ma K, Sivakumar M, Beran T, Scott SD, Vandermeer B, Beirnes N, Graham TAD, Curtis S, Jou H, Hartling L. A randomized trial of robot-based distraction to reduce children's distress and pain during intravenous insertion in the emergency department. CJEM. 2021 Jan;23(1):85-93. doi: 10.1007/s43678-020-00023-5. Epub 2020 Dec 10.

  PMID: 33683608 DERIVED

• Ali S, Sivakumar M, Beran T, Scott SD, Vandermeer B, Curtis S, Jou H, Hartling L. Study protocol for a randomised controlled trial of humanoid robot-based distraction for venipuncture pain in children. BMJ Open. 2018 Dec 14;8(12):e023366. doi: 10.1136/bmjopen-2018-023366.

  PMID: 30552264 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: December 13, 2016
• First Posted: December 20, 2016
• Study Start: April 20, 2017
• Primary Completion: May 13, 2018
• Study Completion: May 13, 2018
• Last Updated: September 19, 2024

Record last verified: 2018-05

Locations

CA (1)