Medi-Port Pilot Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

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.

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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).

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Medi-Port

Intervention Type DEVICE

Treatment

Control Group

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.

Group Type ACTIVE_COMPARATOR

Medi-Port

Intervention Type DEVICE

Control

Interventions

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Medi-Port

Treatment

Intervention Type DEVICE

Medi-Port

Control

Intervention Type DEVICE

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.