Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- External observation for pain and anxiety using OBSD-r scale
研究概览
简要总结
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
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
入排标准
- 年龄范围
- 4 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between age 4-99
- •Will undergo a vascular access procedure
- •English speaking participant and parent or LAR
排除标准
- •Legal guardian not present to obtain consent
- •Child is unable to self-report pain or anxiety
- •Child with a significant neurological condition, or major developmental disability
- •Child with active infection of the hand or arm
- •Major surgery within the last 48 hours
研究组 & 干预措施
BHD only
The participant will wear the BHD 5 cm above the needle insertion site for the duration of the procedure. The BHD will deliver constant low-frequency vibration (CF).
干预措施: Bluetooth Haptic Device (BHD) (Behavioral)
BHD synced with mobile game
At the beginning of the vascular access procedure, the BHD will be applied 5 cm above the needle insertion site and maintained in place throughout the procedure. It delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).
干预措施: BHD synced with mobile game (Behavioral)
Standard of Care
The participant will not receive the BHD device. Participant will receive standard of care treatment.
结局指标
主要结局
External observation for pain and anxiety using OBSD-r scale
时间窗: during vascular access procedure
OBSD-r contains 8-item scale assessing participant's affective state; Information Seeking, Crying, Screaming, Restraint, Verbal Resistance, Emotional Support, Verbal Pain and Flail.
次要结局
- modified induction compliance checklist (mICC)(during vascular access procedure)
- Self formulated procedural satisfaction survey (Patient and Parent)(immediately after vascular access procedure)
- Numerical Rating Pain Scale (NRPS) for patients aged 12-17(during vascular access procedure)
- External observation for pain and anxiety using HRAD scale(during vascular access procedure)
- Self formulated procedural satisfaction survey (Healthcare provider)(immediately after vascular access procedure)
- Faces Pain Scale-Revised for patients aged 4-11(during vascular access procedure)
- Faces Pain Scale-Revised for patients aged 4-11(during vascular access procedure)
- Numerical Rating Pain Scale (NRPS) for patients aged 12-17(during vascular access procedure)
- modified induction compliance checklist (mICC)(during vascular access procedure)
- External observation for pain and anxiety using HRAD scale(during vascular access procedure)
- Children's Anxiety Meter-State (CAM-S) assessment(immediately before, immediately after vascular access procedure)
- Self formulated procedural satisfaction survey (Patient and Parent)(immediately after vascular access procedure)
- Self formulated procedural satisfaction survey (Healthcare provider)(immediately after vascular access procedure)
研究者
Thomas Caruso
Clinical Professor
Stanford University