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This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHD synced with mobile game | Experimental | 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). |
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| BHD only | Other | 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). |
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| Standard of Care | No Intervention | The participant will not receive the BHD device. Participant will receive standard of care treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bluetooth Haptic Device (BHD) | Behavioral | The BHD will deliver constant low-frequency vibration (CF). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | during vascular access procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during vascular access procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Caruso, MD,PhD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Childrens Hospital Stanford | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| BHD synced with mobile game | Behavioral | The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF). |
|
| 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. | 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. | 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. | 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. | 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." | 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." | immediately after vascular access procedure |