Medi-Port Pilot Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Actively Undergoing Cancer Treatment, 4-9 Years of Age, At Least 1 Month From Diagnosis, Able to Speak and Understand English, Presenting to Clinic for at Least a 2nd Subcutaneous Port Needle Insertion

Intervention / Treatment
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* Device: Medi-Port
* Device: Medi-Port


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4-9 years able to speak and understand English, actively undergoing cancer treatment presenting to clinic for at least a 2nd subcutaneous port needle insertion being at least 1 month from diagnosis. Exclusion Criteria: visual, auditory or cognitive impairments precluding interaction with Medi-Port end-of-life patients patients who are nil per os pre-sedation.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Children in the experimental treatment condition will sit in front of the nurse and beside (or on the lap) of a parent. Medi-Port (humanoid robot) will be positioned beside the child (at eye-level) and will execute a pre-programmed series of behaviours to distract the child before, during, and after the SCP needle insertion. The nurse will insert the needle according to hospital procedures, using minimal distraction (e.g., What's on TV?). The estimated time for port procedures and completion of the needle insertion will range from 10-30 minutes. The total estimated time which includes the completion of surveys and questionnaires on the pain intensity of the SCP needle insertion procedure and acceptability of Medi-port will be approximately 1 hour. There will be no follow-up visits. | Device: Medi-Port<br>* Treatment<br>|
| Active Comparator: Control Group<br>Following consent and randomization, children in the (control) usual care condition will sit in front of the nurse and beside (or on the lap) of a parent. Medi-Port (humanoid robot) will be positioned beside the child (at eye-level) and will execute a standard set of dancing movements only. The nurse will insert the needle according to hospital procedures, using minimal distraction (e.g., What's on TV?). The estimated time for port procedures and completion of the needle insertion will range from 10-30 minutes. The total estimated time which includes the completion of surveys and questionnaires on the pain intensity of the SCP needle insertion procedure and acceptability of Medi-port will be approximately 1 hour. There will be no follow-up visits. | Device: Medi-Port<br>* Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 months | 
| Technical difficulties | Technical difficulties (occurrence and description) will be captured using the Medi-Port Intervention Log, designed to record data. | 12 months | 
| Practical difficulties | Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data. | 12 months | 
| Time | Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months |