A clinical trial is a search for hard data. But when CSL launched a trial with young participants ages 2-11, the team wanted this clinical study to have a softer side.
After hearing feedback from caregivers, the study team added a special feature – in the form of an interactive teddy bear – to the trial researching the effectiveness of a medicine for hereditary angioedema, a rare disease that causes dangerous swelling episodes. As trial participants, the children would receive a series of injections and would need blood draws to measure the impact of the medicine. Both involve needles, which can be distressing for patients at any age.
“Clinical Companions,” created by Empath Labs, are designed to be uniquely comforting for children as they progress through the trial. More than just a stuffed toy, the teddy bears have their own app that simulates the medical procedures the child will experience. Empath Labs says the bears offer support while also helping kids better understand medical procedures and feel more prepared for what to expect.
Having an interactive teddy bear companion invites children to use the power of play. For instance, if the child will get an injection, they can “practice” by giving the bear an injection, said LeeAnn Harverstick, Senior Global Trial Leader with CSL. The bear also comes with a passport where kids can collect stickers that mark their progress through the trial.
According to Deirdre BeVard, Senior Vice President, R&D Strategic Operations at CSL, “Providing a smart teddy bear to young participants in our clinical research trial was win-win for everyone. I’m proud that CSL is driving innovation in scientific discovery while also focusing on the humanity of people participating in research. We can’t make progress without them.”
One of Empath Labs’ founders, Aaron J. Horowitz, had human growth hormone deficiency as a child and needed daily injections. It gave him firsthand knowledge of how it feels to be a kid in stressful medical situations and inspired him to found a company dedicated to helping children feel more in control when they’re receiving medical care. Empath Labs’ also has created Comfort Companions for children being treated for cancer, type 1 diabetes and sickle cell disease.
“We’ve found that caring for one of our interactive companions helps children better understand their medical care and emotionally engage with their treatment,” Horowitz said.
Anecdotal reports from kids and caregivers have been positive. A trial site coordinator noted that the bear was helpful when a 5-year-old in Australia was getting a blood draw. Younger children are most enthusiastic about the bear, but some older kids – including twin boys who are 11 – also appreciated their Clinical Companions interactive bear.
“They’re actually sharing the bear,” Harverstick said.
The trial, which recently wrapped up, included 21 children from the U.S., Canada, Germany, Israel and Australia.
Do you want to help your child cope better during medical procedures? Horowitz also recommends that families:
- Create a detailed coping plan with their child to manage medical situations that are causing worry.
- Encourage simulated medical play, such as pretending to take a blood sample from a teddy bear, so the child becomes more comfortable with the different steps of the procedure.
- Find simple ways to let kids feel a sense of control during a care routine. It could be letting them watch a certain video or listen to a particular song before getting an injection or other procedure. Letting them choose can make all the difference.
