An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients

ALTality

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Pediatric Cancer; Pain

Treatments: Device: AR Pain assessment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06635434

1R43DA057744-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Augmented reality-enabled pain assessment deployed on a mobile

Experimental group

Description:

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

Treatment:

Device: AR Pain assessment