NCT05933252

A Pilot Clinical Trial to Determine the Feasibility of Administering an Electronic Tool to Assess Postoperative pAin, Nausea, and Vomiting in English or Spanish-Speaking Pediatric Patients With Neoplastic Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The feasibility of using an electronic tool to measure pain, nausea, and vomiting after surgery in English or Spanish-speaking pediatric cancer patients.

Detailed description

Primary Objective: To determine the feasibility of administering an AR-based electronic tool to assess postoperative pain, nausea, and vomiting in English or Spanish-speaking pediatric patients with neoplastic conditions. Secondary Objectives: 1. To evaluate the willingness to use the AR app, 2. To evaluate the time spent using the AR app (recorded in the study device), 3. To calculate the difference (delta) between pain and nausea intensity recorded from the app and those gathered by nursing personnel, 4. To evaluate app recorded responses to pain intensity, 5. To evaluate app recorded responses to nausea intensity, 6. To assess the frequency of vomiting, 7. To measure the length of stay in PACU (calculated from the EMR), 8. To determine the rate (number) of assessments completed, 9. To calculate PACU opioid use, 10. To calculate opioid use during hospitalization, 11. To assess the quality of life using the PedsQL Cancer Module survey responses (administered by the study team), 12. To evaluate patient/caregiver satisfaction following the PACU stay 13. To assess nursing experience with AR tool following patient discharge from PACU. Exploratory Objectives: 1. To assess the primary/secondary outcomes for the English and Spanish-speaking patients separately. 2. To correlate pain-reported intensity to the analgesia nociception index (ANI).

Conditions

• Neoplastic Conditions

Interventions

Type	Name	Description
OTHER	Augmented reality (AR)	an app on an iPad every 15 minutes

Timeline

• Start date: 2023-06-19
• Primary completion: 2025-04-21
• Completion: 2025-04-21
• First posted: 2023-07-06
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States