IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT06635434 para Dolor, Cáncer pediátrico está activo, no reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un ensayo coincide con los criterios de filtro
Vista de tarjeta
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El ensayo clínico NCT06635434 está diseñado para estudiar la viabilidad del dispositivo de Dolor, Cáncer pediátrico. Es un estudio intervencionista de Fase I temprana. Su estado actual es: activo, no reclutando. El ensayo se inició el 5 de febrero de 2023, con el objetivo de reclutar a 16 participantes. Dirigido por ALTality, Inc., se espera que finalice el 30 de noviembre de 2024. Los datos se actualizaron por última vez en ClinicalTrials.gov el 26 de octubre de 2024.
Resumen
In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.
Título oficial
Feasibility of a Dual English/Spanish Mobile Augmented Reality Pain Assessment App to Reduce Postoperative Prescription Opioid Use in Hispanic/Latino Pediatric and Adolescent Cancer Patients
Condiciones médicas
DolorCáncer pediátricoPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este ensayo clínico:- Kamaladevi RK, Elakkumanan LB, Regmi S. Smart Anesthesia-Another Way of Communication During Emergence from Anesthesia Using a Smartphone. Anesth Analg. 2016 Aug;123(2):518. doi: 10.1213/ANE.0000000000001400. No abstract available.
- Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.
Otros ID del ensayo
Número del NCT
Inicio del ensayo (real)
2023-02-05
Última actualización
2024-10-26
Fecha de finalización (estimada)
2024-11-30
Inscripción (prevista)
16
Tipo de estudio
Intervencionista
FASE
Fase I temprana
Estado general
Activo, no reclutando
Objetivo principal
Viabilidad del dispositivo
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalAugmented reality-enabled pain assessment deployed on a mobile Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration | AR Pain Assessment Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Primary; Percent of enrolled patients who activated/used the app during the PACU stay | Feasibility measured as activation/usage of the app recorded by the device ID for each patient | immediately after the intervention/procedure/surgery |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Total time spent playing on the AR app during the PACU stay | Length of time (minutes) of app usage recorded by the device ID for each patient | immediately after the intervention/procedure/surgery |
Recorded responses about pain assessment from the app | Pain scale score in English or Spanish through the app | immediately after the intervention/procedure/surgery |
Recorded responses about nausea/vomit assessment from the app | Baxter animated retching scale score in English or Spanish through the app | immediately after the intervention/procedure/surgery |
Inpatient opioid consumption | Calculated as morphine equivalent dose of all opioids given | immediately after the intervention/procedure/surgery |
Length of stay | Total time (minutes) spent in the PACU after surgery | immediately after the intervention/procedure/surgery |
Quality of life survey | PedsQL survey administered to child and/or adult caregiver stratified by age | immediately after the intervention/procedure/surgery |
Rate of opioid prescription | The percentage of patients with opioid prescriptions at the time of discharge from the electronic health record | immediately after the intervention/procedure/surgery |
Patient/caregiver satisfaction survey | Asked to the patient/caregiver by the study team - 1) How satisfied were you with regards to your pain management in PACU?, 2) How satisfied were you with regards to your nausea management in PACU?, 3) How satisfied were you with the use of the AR app to help assess your pain and nausea? | immediately after the intervention/procedure/surgery |
Criterios de elegibilidad
Criterios de edad
Niño
Edad mínima
7 Years
Criterios de sexo
Todos
- ages 7-17 years old
- child able to provide assent, and a legal guardian able to provide informed consent
- current diagnosis of pediatric cancer
- undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization
- prescribed or expected to be prescribed opioids during inpatient perioperative period
- sufficient mental capacity to comprehend and interact with the game in English or Spanish.
- the inability to play with the SpellBound app from English or Spanish instructions
- daily opioid use within 30 days prior to surgery
- any concerns from the treatment team.
ALTality, Inc.Centro Oncológico MD AndersonNo hay datos de contacto.
1 Sitios del ensayo en 1 países
Texas
MD Anderson Cancer Center, Houston, Texas, 77054, United States