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.

Not Applicable

Completed

• Conditions: Neoplastic Conditions
• Interventions: Other: Augmented reality (AR)

• Registration Number: NCT05933252
• Lead Sponsor: M.D. Anderson Cancer Center

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.

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 Timeline

• Study Start: 2023-06-19
• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-06
• Status Verified: 2025-04
• Primary Completion: 2025-04-21
• Study Completion: 2025-04-21
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Augmented reality (AR)	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States