Anxiety, Pain
Conditions
Keywords
Vascular access
Brief summary
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
Interventions
BEHAVIORALBluetooth Haptic Device (BHD)
The BHD will deliver constant low-frequency vibration (CF).
BEHAVIORALBHD synced with mobile game
The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF).
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Between age 4-99 * Will undergo a vascular access procedure * English speaking participant and parent or LAR
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| External observation for pain and anxiety using OBSD-r scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified induction compliance checklist (mICC) | during vascular access procedure | 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. |
| External observation for pain and anxiety using HRAD scale | during vascular access procedure | HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation. |
| Faces Pain Scale-Revised for patients aged 4-11 | during vascular access procedure | 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. |
| Self formulated procedural satisfaction survey (Healthcare provider) | immediately after vascular access procedure | 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." |
| Children's Anxiety Meter-State (CAM-S) assessment | immediately before, immediately after vascular access procedure | 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. |
| Numerical Rating Pain Scale (NRPS) for patients aged 12-17 | during vascular access procedure | NRPS is a 11-point (0-10) Numeric Rating Pain Scale (NRPS), where 0 = no pain and 10 = worst possible pain. |
| Self formulated procedural satisfaction survey (Patient and Parent) | immediately after vascular access procedure | 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." |
Countries
United States
Contacts
STUDY_DIRECTORThomas Caruso, MD,PhD
Stanford University
Outcome results
None listed