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Neoplastic ConditionsNCT05933252

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.

A study testing Augmented reality (AR) in people with Neoplastic Conditions, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Neoplastic Conditions
What is being tested?
Augmented reality (AR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
19 Jun 2023to 21 Apr 2025
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

Read the 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).
Being tested
Augmented reality (AR)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented reality (AR)Other

    an app on an iPad every 15 minutes

Study groups in NCT05933252
Study groupRoleWhat they receive
Augmented reality (AR)ExperimentalAugmented 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
Receives: Other: Augmented reality (AR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Activation and use of the technology (YES versus NO)

    Measured: through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2023
  2. Study start19 Jun 2023
  3. Primary completion21 Apr 2025
  4. Study completion21 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05933252
Sponsor's protocol ID
2023-0097
Other IDs
NCI-2023-04990
Status last verified
Apr 2025
First submitted
19 Jun 2023
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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