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.
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.
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:
- To evaluate the willingness to use the AR app,
- To evaluate the time spent using the AR app (recorded in the study device),
- To calculate the difference (delta) between pain and nausea intensity recorded from the app and those gathered by nursing personnel,
- To evaluate app recorded responses to pain intensity,
- To evaluate app recorded responses to nausea intensity,
- To assess the frequency of vomiting,
- To measure the length of stay in PACU (calculated from the EMR),
- To determine the rate (number) of assessments completed,
- To calculate PACU opioid use,
- To calculate opioid use during hospitalization,
- To assess the quality of life using the PedsQL Cancer Module survey responses (administered by the study team),
- To evaluate patient/caregiver satisfaction following the PACU stay
- To assess nursing experience with AR tool following patient discharge from PACU.
Exploratory Objectives:
- To assess the primary/secondary outcomes for the English and Spanish-speaking patients separately.
- To correlate pain-reported intensity to the analgesia nociception index (ANI).
- Conditions
- Neoplastic Conditions
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Augmented reality (AR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted6 Jul 2023
- Study start19 Jun 2023
- Primary completion21 Apr 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic ConditionsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Drug Abuse
- Responsible party
- Sponsor
- Investigators
- Juan Cata, MD, Principal investigator, M.D. Anderson Cancer Center
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