This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,100
The BHD will deliver constant low-frequency vibration (CF).
The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).
Lucile Packard Childrens Hospital Stanford
Palo Alto, California, United States
External observation for pain and anxiety using OBSD-r scale
OBSD-r contains 8-item scale assessing participant's affective state; Information Seeking, Crying, Screaming, Restraint, Verbal Resistance, Emotional Support, Verbal Pain and Flail.
Time frame: during vascular access procedure
Faces Pain Scale-Revised for patients aged 4-11
Detailed qualitative review of cognitive interview probes with question-by-question analysis of transcribed cognitive interviews to assess for basic comprehension and appropriate use of the FPS-R. This scale is measured from 0-10, where 0 = no pain and 10 = very much pain.
Time frame: during vascular access procedure
Numerical Rating Pain Scale (NRPS) for patients aged 12-17
NRPS is a 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain.
Time frame: during vascular access procedure
modified induction compliance checklist (mICC)
The mICC score will be recorded by the trained research observers during the vascular access procedure. Perfect compliance (score of 0) was compared to those that lacked cooperation. mICC will be rated at the time of intervention and only requires one RA.
Time frame: during vascular access procedure
External observation for pain and anxiety using HRAD scale
HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.
Time frame: during vascular access procedure
Children's Anxiety Meter-State (CAM-S) assessment
The CAM-S is completed by showing the child a picture of a mercury thermometer. This scale is measured from 1-10. Higher values indicate higher anxiety.
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Time frame: immediately before, immediately after vascular access procedure
Self formulated procedural satisfaction survey (Patient and Parent)
The survey contains 10 items and utilizes a 5-point Likert agreement scale with a score of 1 meaning "completely disagree" and 5 meaning "completely agree."
Time frame: immediately after vascular access procedure
Self formulated procedural satisfaction survey (Healthcare provider)
The survey contains 5 items and utilizes a 5-point Likert agreement scale with a score of 1 meaning "completely disagree" and 5 meaning "completely agree."
Time frame: immediately after vascular access procedure