IA Trial Radar | ||
|---|---|---|
L'essai clinique NCT06635434 pour Douleur, Cancer pédiatrique est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT06635434 est conçu pour étudier la faisabilité du dispositif de Douleur, Cancer pédiatrique. Il s'agit d'un essai interventionnel en Phase I précoce. Son statut actuel est : actif, pas en recrutement. L'essai a débuté le 5 février 2023 et vise à recruter 16 participants. Dirigé par ALTality, Inc., l'essai devrait être terminé d'ici le 30 novembre 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 26 octobre 2024.
Résumé succinct
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.
Titre officiel
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
Conditions
DouleurCancer pédiatriquePublications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:- 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.
Autres identifiants de l'essai
Numéro NCT
Date de début (réel)
2023-02-05
Dernière mise à jour publiée
2024-10-26
Date de fin (estimée)
2024-11-30
Inscription (estimée)
16
Type d'essai
Interventionnel
PHASE
Phase I précoce
Statut
Actif, pas en recrutement
Objectif principal
Faisabilité du dispositif
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalAugmented 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 |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
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 |
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
7 Years
Sexes éligibles
Tous
- 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.Centre médical MD AndersonAucune donnée de contact disponible
1 Centres de l'essai dans 1 pays
Texas
MD Anderson Cancer Center, Houston, Texas, 77054, United States