Examining Bluetooth Haptic Device Use for Pain and Distress Reduction in Vascular Access Procedures (VA+BHD)
Examining Bluetooth Haptic Device Use for Pain and Distress Reduction in Vascular Access Procedures (VA+BHD)
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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California
-
Palo Alto, California, Vereinigte Staaten, 94304
- Lucile Packard Childrens Hospital Stanford
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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). |
The BHD delivers a constant low-frequency vibration as well as tactile feedback from the game (GF). |
|
Sonstiges: 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). |
The BHD will deliver constant low-frequency vibration (CF). |
|
Kein Eingriff: Standard of Care
The participant will not receive the BHD device. Participant will receive standard of care treatment. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
External observation for pain and anxiety using OBSD-r scale
Zeitfenster: 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. |
during vascular access procedure
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
modified induction compliance checklist (mICC)
Zeitfenster: 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. |
during vascular access procedure
|
|
External observation for pain and anxiety using HRAD scale
Zeitfenster: 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. |
during vascular access procedure
|
|
Faces Pain Scale-Revised for patients aged 4-11
Zeitfenster: 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. |
during vascular access procedure
|
|
Numerical Rating Pain Scale (NRPS) for patients aged 12-17
Zeitfenster: 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. |
during vascular access procedure
|
|
Self formulated procedural satisfaction survey (Healthcare provider)
Zeitfenster: 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." |
immediately after vascular access procedure
|
|
Self formulated procedural satisfaction survey (Patient and Parent)
Zeitfenster: 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." |
immediately after vascular access procedure
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Thomas Caruso, MD,PhD, Stanford University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 73750
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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