Medi-Port Pilot Randomized Controlled Trial

The Hospital for Sick Children

Status: Completed

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

Treatments: Device: Medi-Port

Study type: Interventional

Funder types: Other

Identifiers

NCT02611739

1000049494

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 40 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Device: Medi-Port

Device: Medi-Port

Control Group

Active Comparator group

Description:

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.

Treatment:

Device: Medi-Port

Device: Medi-Port