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.

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

Study Overview

• Status: Completed
• Conditions: Neoplastic Conditions
• Intervention / Treatment: Other: Augmented reality (AR)

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).

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Ages 7-17 years old,
2. Able to provide assent, and a legal guardian able to provide informed consent
3. Current diagnosis of pediatric cancer or benign neoplasm,
4. Surgery with an estimated duration longer than 2 hours,
5. An expected prescription of opioids during the inpatient perioperative period
6. Demonstrate capacity to comprehend and interact with the game in English or Spanish.

Exclusion criteria:

1. Any concerns from the principal investigator or primary team about the use of the app,
2. Inability or refusal from the parents to provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmented reality (AR); Augmented reality (AR) Participants will view the real world through a device's camera and application ("app") but adds virtual or digital characters and items to the image	Other: Augmented reality (AR); an app on an iPad every 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activation and use of the technology (YES versus NO)	through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institute of Drug Abuse
• Investigators: Principal Investigator: Juan Cata, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): April 21, 2025
• Study Completion (Actual): April 21, 2025

Study Registration Dates

• First Submitted: June 19, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Digestive; Disease; Vomiting
• Other Study ID Numbers: 2023-0097; NCI-2023-04990 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No