Clinical trial NCT06635434: An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pain
Pediatric Cancer
Lead sponsor: ALTality, Inc.
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2024-10-10
Enrollment: 16
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary; Percent of enrolled patients who activated/used the app during the PACU stay
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Total time spent playing on the AR app during the PACU stay
timeFrame: immediately after the intervention/procedure/surgery
measure: Recorded responses about pain assessment from the app
timeFrame: immediately after the intervention/procedure/surgery
measure: Recorded responses about nausea/vomit assessment from the app
timeFrame: immediately after the intervention/procedure/surgery
measure: Inpatient opioid consumption
timeFrame: immediately after the intervention/procedure/surgery
measure: Length of stay
timeFrame: immediately after the intervention/procedure/surgery
measure: Quality of life survey
timeFrame: immediately after the intervention/procedure/surgery
measure: Rate of opioid prescription
timeFrame: immediately after the intervention/procedure/surgery
measure: Patient/caregiver satisfaction survey
timeFrame: immediately after the intervention/procedure/surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: ALTality, Inc.
name: Christina York
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.