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
Are there results?: None posted in the registry

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:

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 groups in NCT05933252
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.

19 Jun 202321 Apr 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neoplastic Conditions trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT05933252
Acronym / sponsor ID: 2023-0097
Conditions: Neoplastic Conditions
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Institute of Drug Abuse
Study start: 19 Jun 2023 (actual)
Primary completion: 21 Apr 2025 (actual)
Study completion: 21 Apr 2025 (actual)
First posted: 6 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

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).

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Augmented reality (AR)	Experimental	Other: 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

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Augmented reality (AR)an app on an iPad every 15 minutes	Other	Augmented reality (AR)

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
M D Anderson Cancer CenterLink provided by the sponsor.

Related trials for Neoplastic Conditions

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juan Cata, MD principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Activation and use of the technology (YES versus NO) (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05933252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.