Pain Clinical Trial
Official title:
Socially Assistive Robots to Reduce Children's Pain During Peripheral IV Placement
Verified date | January 2024 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Peripheral intravenous catheters (IVs) are utilized in the majority of hospitalized children. The placement of IVs requires significant staff time, contributes to health care costs, and causes pain and distress in the patients receiving them. Techniques currently used at Children's Hospital Los Angeles (CHLA) to reduce children's anxiety and increase success of IV placement center depends on members of the Child Life Department distracting patients during insertion. Recent literature has suggested that humanoid robots can be a powerful form of distraction and lead to decreased pain during painful procedures in children. Work done by the University of Southern California (USC) Interaction Lab has shown that socially assistive robots can use techniques more complex than pure distraction to lead to a human-robot interaction that is perceived as more positive by the human. The investigators propose a project pairing children receiving an IV with either a (1) Child Life staff member only (2) pure distraction robot + Child Life or (3) an robot teaching coping skills + Child Life with a goal of reduced pain. Pain will be measured by participant self-report, family member perceived pain, parasympathetic activation, and pain behaviors as measured by video.
Status | Completed |
Enrollment | 34 |
Est. completion date | July 20, 2019 |
Est. primary completion date | July 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility | Inclusion Criteria: - Speaks English or Spanish - Age limits - would be getting IV and child life regardless of participation in study Exclusion Criteria: - severe developmental delay (parent assessment) - afraid of robots |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles | University of Southern California |
United States,
Beran TN, Ramirez-Serrano A, Vanderkooi OG, Kuhn S. Reducing children's pain and distress towards flu vaccinations: a novel and effective application of humanoid robotics. Vaccine. 2013 Jun 7;31(25):2772-7. doi: 10.1016/j.vaccine.2013.03.056. Epub 2013 Apr 24. — View Citation
Okita SY. Self-other's perspective taking: the use of therapeutic robot companions as social agents for reducing pain and anxiety in pediatric patients. Cyberpsychol Behav Soc Netw. 2013 Jun;16(6):436-41. doi: 10.1089/cyber.2012.0513. Epub 2013 Mar 18. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Pain Scale Score from baseline to post-intervention | Using Wong-baker faces pain scale | through study completion, an average of 1 hour | |
Secondary | IV placement attempts | record raw number of attempts to compare average between arms | through study completion, an average of 1 hour | |
Secondary | Patient/Child satisfaction with robot interaction | by survey | Day 1 | |
Secondary | CAMPIS score | on video review | Day 1 | |
Secondary | mYPAS score | on video review | Day 1 | |
Secondary | Change in Anxiety Scale Score from baseline to post-intervention | using fear faces scale | through study completion, an average of 1 hour | |
Secondary | heart rate | using pulse oximeter | through study completion, an average of 1 hour |
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