Using a Humanoid Robot to Reduce Procedural Pain and Distress in Children With Cancer: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Accrual rates
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •visual, auditory or cognitive impairments precluding interaction with Medi-Port
- •end-of-life patients
- •patients who are nil per os pre-sedation.
研究组 & 干预措施
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.
干预措施: Medi-Port (Device)
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.
干预措施: Medi-Port (Device)
结局指标
主要结局
Accrual rates
时间窗: 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
时间窗: 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
时间窗: 12 months
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Technical difficulties
时间窗: 12 months
Technical difficulties (occurrence and description) will be captured using the Medi-Port Intervention Log, designed to record data.
Time
时间窗: 12 months
Practical difficulties will be captured using the Medi-Port Intervention Log, designed to record data.
Outcome measure feasibility
时间窗: 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.
次要结局
- Pain intensity(12 months)
- Distress(12 months)
研究者
Jennifer Stinson
Clinician Scientist, Clinical Nurse Specialist/NP
The Hospital for Sick Children