Completed

NCT Number: NCT02611739

Medi-Port Pilot Randomized Controlled Trial

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.

Completed

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Key information

Conditions

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

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medi-Port

Device

Treatment

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.
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.
Technical difficulties

Time frame: 12 months

Technical difficulties (occurrence and description) will be captured using the Medi-Port Intervention Log, designed to record data.
Practical difficulties

Time frame: 12 months

Practical difficulties 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.

Secondary outcomes

Pain intensity

Time frame: 12 months

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.
Distress

Time frame: 12 months

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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

University of Calgary

Registry information

Official study title

Using a Humanoid Robot to Reduce Procedural Pain and Distress in Children With Cancer: A Pilot Randomized Controlled Trial

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Nov 23, 2015
Registry last updated: Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.