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.

M.D. Anderson Cancer Center

Status: Completed

Conditions: Neoplastic Conditions

Treatments: Other: Augmented reality (AR)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05933252

NCI-2023-04990 (Other Identifier)

2023-0097

Details and patient eligibility

About

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

Full 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).

Enrollment: 14 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Augmented reality (AR)

Experimental group

Description:

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

Treatment:

Other: Augmented reality (AR)