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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Hospital for Sick Children
Toronto, Ontario, Canada
Accrual rates
Accrual rates will be captured by recording data related to the number of eligible children per recruitment day, reasons for ineligibility, and reasons for non-participation.
Time frame: 12 months
Acceptability
Acceptability will be measured using the Medi-Port Satisfaction Questionnaire completed by children, parent, and nurses that will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.
Time frame: 12 months
Outcome measure feasibility
Outcome measure feasibility will be measured as the percentage of completed outcome measures at baseline and study completion (100% when all questionnaires are completed) and will be recorded on Medi-Port Activity Log.
Time frame: 12 months
Technical difficulties
Technical difficulties (occurrence and description) will be captured using the Medi-Port Intervention Log, designed to record data.
Time frame: 12 months
Practical difficulties
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Time frame: 12 months
Time
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Time frame: 12 months
Pain intensity
Pain intensity (both retrospectively for previous SCP access and after the study procedures) will be measured. Children will self-report their pain and parents, nurses, and the researcher will use proxy-reporting in rating children's pain. Children will use the Faces Pain Scale-Revised (FPS-R) which has been validated in children 4 years and older. Parents, nurses, and the researcher will use an 11-point numerical rating scale (NRS), with verbal anchors of "no pain at all" at 0 and "the most pain you can imagine this child having" at 10.
Time frame: 12 months
Distress
Distress (both retrospectively for previous SCP access and after the study procedures will be measured). Children will retrospectively report fear using the Children's Fear Scale (CFS), which is a visual scale with established psychometrics in children 5-10 years. Parents will retrospectively report pain using an 11-point NRS. Distress during the study SCP access will be measured using the observer-rated Behavioral Approach-Avoidance Scale (BAADS). The same 2 trained research team members will code video-recordings from all SCP needle insertions using the BAADS. Child distress behaviours will be scored at specific steps during the procedure: 1) nurse movement towards the child 2) pre-procedure skin sterilization 3) SCP position assessment by nurse 4) needle insertion 5) sterile dressing application.
Time frame: 12 months
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