4-9 Years of Age Clinical Trial
Official title:
Using a Humanoid Robot to Reduce Procedural Pain and Distress in Children With Cancer: A Pilot Randomized Controlled Trial
| Verified date | December 2017 |
| Source | The Hospital for Sick Children |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 2016 |
| Est. primary completion date | September 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 4 Years to 9 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hospital for Sick Children | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| The Hospital for Sick Children | University of Calgary |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Technical difficulties | Technical difficulties (occurrence and description) will be captured using the Medi-Port Intervention Log, designed to record data. | 12 months | |
| Primary | Practical difficulties | Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data. | 12 months | |
| Primary | Time | Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data. | 12 months | |
| Secondary | 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 | |
| Secondary | 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 |