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.

NCT05933252 | Completed

• 2 other identifiers: 2023-0097NCI-2023-04990
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neoplastic Conditions

Outcome Measures

Primary Outcomes (1)

• Activation and use of the technology (YES versus NO)

  through study completion; an average of 1 year

Study Arms (1)

Augmented reality (AR)

EXPERIMENTAL

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)

Interventions

Augmented reality (AR) OTHER

an app on an iPad every 15 minutes

Augmented reality (AR)

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institute of Drug Abuse: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

Study Officials

• Juan Cata, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 6, 2023
• Study Start: June 19, 2023
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)