Using a Humanoid Robot to Reduce Procedural Pain and Distress in Children With Cancer: A Pilot Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Actively Undergoing Cancer Treatment
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Accrual rates
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/NP
The Hospital for Sick Children
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.
Outcomes
Primary Outcomes
Accrual rates
Time Frame: 12 months
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.
Acceptability
Time Frame: 12 months
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.
Practical difficulties
Time Frame: 12 months
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Technical difficulties
Time Frame: 12 months
Technical difficulties (occurrence and description) will be captured using the Medi-Port Intervention Log, designed to record data.
Time
Time Frame: 12 months
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Outcome measure feasibility
Time Frame: 12 months
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.
Secondary Outcomes
- Pain intensity(12 months)
- Distress(12 months)