Clinical trial NCT02611739: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2015-11-23
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Accrual rates
timeFrame: 12 months
measure: Acceptability
timeFrame: 12 months
measure: Outcome measure feasibility
timeFrame: 12 months
measure: Technical difficulties
timeFrame: 12 months
measure: Practical difficulties
timeFrame: 12 months
measure: Time
timeFrame: 12 months
Secondary outcomes:
measure: Pain intensity
timeFrame: 12 months
measure: Distress
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jennifer Stinson, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Paul Nathan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Tanya Beran, PhD, RPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Lindsay Jibb, RN, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jibb LA, Birnie KA, Nathan PC, Beran TN, Hum V, Victor JC, Stinson JN. Using the MEDiPORT humanoid robot to reduce procedural pain and distress in children with cancer: A pilot randomized controlled trial. Pediatr Blood Cancer. 2018 Sep;65(9):e27242. doi: 10.1002/pbc.27242. Epub 2018 Jun 12.