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.
NCT ID: NCT05933252
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2023-06-19
2025-04-21
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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
Augmented reality (AR)
an app on an iPad every 15 minutes
Interventions
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Augmented reality (AR)
an app on an iPad every 15 minutes
Eligibility Criteria
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Inclusion Criteria
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
2. Inability or refusal from the parents to provide written informed consent.
7 Years
17 Years
ALL
No
Sponsors
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National Institute of Drug Abuse
FED
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Juan Cata, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2023-04990
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0097
Identifier Type: -
Identifier Source: org_study_id
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