To hear about similar clinical trials, please enter your email below
Trial Title:
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
NCT ID:
NCT06635434
Condition:
Pain
Pediatric Cancer
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Device Feasibility
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
AR Pain assessment
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
Arm group label:
Augmented reality-enabled pain assessment deployed on a mobile
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.
Criteria for 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.
Gender:
All
Minimum age:
7 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77054
Country:
United States
Start date:
February 5, 2023
Completion date:
November 30, 2024
Lead sponsor:
Agency:
ALTality, Inc.
Agency class:
Industry
Collaborator:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
ALTality, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06635434
