Bubble Blowing As an Effective Method for Distraction During Pediatric IV Insertion: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Pain after IV insertion
研究概览
简要总结
Insertion of an IV cannula is a standard but potentially painful procedure. Distraction techniques are among the strategies used to alleviate this discomfort. The investigators are conducting a randomized controlled trial to assess whether bubble blowing is more effective than video distraction during IV insertions in young children in the medical imaging suite.
详细描述
Purpose:
To assess the effectiveness of two distraction techniques used to reduce the perceived pain of pediatric IV insertions, comparing bubble blowing versus watching videos.
Hypotheses:
- Blowing bubbles will reduce perceived pain during IV insertions more than video watching in two- to five-year-olds.
- Bubble-blowing will reduce child anxiety with IV insertion more than video watching.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Cannot blind participants due to the nature of the intervention
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between the ages of two to five years (i.e. ≥ two years to < six years) requiring an IV in the medical imaging department.
排除标准
- •Children with existing vascular access (do not have an IV placed)
- •Families who chose not to have topical anesthetic placed on their child's hands (will have a different amount of pain with the procedure than children who have had topical anesthetic)
- •Children receiving anxiolytic premedication (will have reduced anxiety associated with the procedure)
- •Children planned to undergo mask induction of anesthesia before IV placement (will not be awake to experience distraction method during IV insertion procedure)
- •Children who had inadequate time for the local anesthetic cream/gel to take effect (pain will be experienced differently, and the effect of the local anesthetic will be more variable)
研究组 & 干预措施
Bubbles
Patient will receive bubble distraction method prior to and during the placement of their IV cannula
干预措施: Bubble blowing (active) (Behavioral)
Video
Patient will receive video distraction on an tablet computer prior to and during the placement of their IV cannula
干预措施: Video distraction (passive) (Behavioral)
结局指标
主要结局
Pain after IV insertion
时间窗: once the IV insertion procedure is complete
Observed pain score after IV insertion at timepoint 3 (once the IV insertion procedure is complete) as measured by FLACC scale
Pain before IV insertion
时间窗: at removal of topical anesthetic
Observed pain score before IV insertion at timepoint 1 (removal of topical anesthetic), assessed using Face, Legs, Activity, Cry, Consolability (FLACC) scale (observer pain rating assessed on 5 dimensions with total scores ranging from 0 indicating no pain to 10 indicating highest pain).
Pain during IV insertion
时间窗: at the moment of skin penetration
Observed pain score during IV insertion at timepoint 2 (the moment of skin penetration) as measured by FLACC scale
次要结局
- Anxiety after consent(up to 5 minutes in waiting room immediately after consent)
- Anxiety before IV insertion(between entering procedure room (or clinician approaching) until first IV insertion attempt)
研究者
James Chen
Principal Investigator
University of British Columbia