Medi-Port Pilot Randomized Controlled Trial

Official Title

Using a Humanoid Robot to Reduce Procedural Pain and Distress in Children With Cancer: A Pilot Randomized Controlled Trial

Summary:

Pain is a frequent and significant problem related to cancer-directed treatment in children. Children with cancer often cite needle procedures as the most distressing experience caused by cancer and its treatment. Recently it has been shown that an interactive humanoid robot is capable of facilitating distraction and reducing distress during childhood immunizations. Our research objectives are to: (1) assess the feasibility of implementing the robot (Medi-Port) for effectiveness testing in a future RCT (measured as implementation outcomes) and (2) determine treatment effectiveness estimates (measured as preliminary effectiveness outcomes), compared to standard medical care.

Trial Description

Primary Outcome:

  • Accrual rates
  • Acceptability
  • Outcome measure feasibility
  • Technical difficulties
  • Practical difficulties
  • Time
Secondary Outcome:
  • Pain intensity
  • Distress
A sample of 40 children with cancer between the ages of 4-9 years (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited. The feasibility of the trial protocol to evaluate the impact of distraction via the humanoid robot on pain intensity and distress during SCP needle insertion compared to an active control in children with cancer will be explored. The effectiveness outcome includes the examination of the robot programmed to distract children during the procedure, reduce pain intensity and distress compared to an active control intervention (i.e. dancing robot).

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society