PainEarly Phase 1NCT06635434
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
A Early Phase 1 study testing AR Pain assessment in people with Pain and Pediatric Cancer, run by ALTality, Inc. at 1 site in United States.
Trial summary
In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking… Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Pain, Pediatric Cancer
- What is being tested?
- AR Pain assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2023to 30 Nov 2024
- Phase
- Early Phase 1
- 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
- child able to provide assent, and a legal guardian able to provide informed consent
- current diagnosis of pediatric cancer
- undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization
- prescribed or expected to be prescribed opioids during inpatient perioperative period
- sufficient mental capacity to comprehend and interact with the game in English or Spanish.
Who cannot join
- the inability to play with the SpellBound app from English or Spanish instructions
- daily opioid use within 30 days prior to surgery
- any concerns from the treatment team.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Dual English/Spanish Mobile Augmented Reality Pain Assessment App to Reduce Postoperative Prescription Opioid Use in Hispanic/Latino Pediatric and Adolescent Cancer Patients
In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.
- Conditions
- Pain, Pediatric Cancer
- Being tested
- AR Pain assessment
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR Pain assessmentDevice
Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration
| Study group | Role | What they receive |
|---|---|---|
| Augmented reality-enabled pain assessment deployed on a mobile | Experimental | Age-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration Receives: Device: AR Pain assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary; Percent of enrolled patients who activated/used the app during the PACU stay
Feasibility measured as activation/usage of the app recorded by the device ID for each patient
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (8)
Total time spent playing on the AR app during the PACU stay
Length of time (minutes) of app usage recorded by the device ID for each patient
Measured: immediately after the intervention/procedure/surgery
Recorded responses about pain assessment from the app
Pain scale score in English or Spanish through the app
Measured: immediately after the intervention/procedure/surgery
Recorded responses about nausea/vomit assessment from the app
Baxter animated retching scale score in English or Spanish through the app
Measured: immediately after the intervention/procedure/surgery
Inpatient opioid consumption
Calculated as morphine equivalent dose of all opioids given
Measured: immediately after the intervention/procedure/surgery
Length of stay
Total time (minutes) spent in the PACU after surgery
Measured: immediately after the intervention/procedure/surgery
Quality of life survey
PedsQL survey administered to child and/or adult caregiver stratified by age
Measured: immediately after the intervention/procedure/surgery
Rate of opioid prescription
The percentage of patients with opioid prescriptions at the time of discharge from the electronic health record
Measured: immediately after the intervention/procedure/surgery
Patient/caregiver satisfaction survey
Asked to the patient/caregiver by the study team - 1) How satisfied were you with regards to your pain management in PACU?, 2) How satisfied were you with regards to your nausea management in PACU?, 3) How satisfied were you with the use of the AR app to help assess your pain and nausea?
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start5 Feb 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALTality, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Christina York, Principal investigator, ALTality, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635434
- Sponsor's protocol ID
- 1R43DA057744-01
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pediatric cancer diagnoses are rare and by definition could identify individual patients and violate patient privacy.
Publications
Kamaladevi RK, Elakkumanan LB, Regmi S. Smart Anesthesia-Another Way of Communication During Emergence from Anesthesia Using a Smartphone. Anesth Analg. 2016 Aug;123(2):518. doi: 10.1213/ANE.0000000000001400. No abstract available.
PubMed 27258079Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.
PubMed 27802492
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Dual English/Spanish Mobile Augmented Reality Pain Assessment App to Reduce Postoperative Prescription Opioid Use in Hispanic/Latino Pediatric and Adolescent Cancer Patients
- ClinicalTrials.gov ID
- NCT06635434
- Acronym / sponsor ID
- 1R43DA057744-01
- Conditions
- Pain, Pediatric Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- ALTality, Inc.Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 10 Oct 2024 (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.
In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Augmented reality-enabled pain assessment deployed on a mobile | Experimental | Device: AR Pain assessmentAge-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration |
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
- child able to provide assent, and a legal guardian able to provide informed consent
- current diagnosis of pediatric cancer
- undergoing surgery for cancer treatment requiring postoperative inpatient hospitalization
- prescribed or expected to be prescribed opioids during inpatient perioperative period
Key exclusion criteria (3 listed)
- the inability to play with the SpellBound app from English or Spanish instructions
- daily opioid use within 30 days prior to surgery
- any concerns from the treatment team.
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 |
|---|---|---|
| AR Pain assessmentAge-stratified (age 7-11 and age 12-17 years old) augmented reality app to evaluate for pain and opioid-related adverse events with equivalent English and Spanish text, audio, and narration | Device | Augmented reality-enabled pain assessment deployed on a mobile |
Primary outcome
Primary; Percent of enrolled patients who activated/used the app during the PACU stay
Time frame: immediately after the intervention/procedure/surgery
Feasibility measured as activation/usage of the app recorded by the device ID for each patient
8 secondary outcomes
Total time spent playing on the AR app during the PACU stay
Time frame: immediately after the intervention/procedure/surgery
Recorded responses about pain assessment from the app
Time frame: immediately after the intervention/procedure/surgery
Recorded responses about nausea/vomit assessment from the app
Time frame: immediately after the intervention/procedure/surgery
Inpatient opioid consumption
Time frame: immediately after the intervention/procedure/surgery
Length of stay
Time frame: immediately after the intervention/procedure/surgery
Quality of life survey
Time frame: immediately after the intervention/procedure/surgery
Rate of opioid prescription
Time frame: immediately after the intervention/procedure/surgery
Patient/caregiver satisfaction survey
Time frame: immediately after the intervention/procedure/surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 27258079Kamaladevi RK, Elakkumanan LB, Regmi S. Smart Anesthesia-Another Way of Communication During Emergence from Anesthesia Using a Smartphone. Anesth Analg. 2016 Aug;123(2):518. doi: 10.1213/ANE.0000000000001400. No abstract available.
- Background: PubMed 27802492Gaither JR, Leventhal JM, Ryan SA, Camenga DR. National Trends in Hospitalizations for Opioid Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr. 2016 Dec 1;170(12):1195-1201. doi: 10.1001/jamapediatrics.2016.2154.
- Individual participant dataSharing planned: No. Pediatric cancer diagnoses are rare and by definition could identify individual patients and violate patient privacy.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Christina York principal investigator
ALTality, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing AR Pain assessment in people with Pain and Pediatric Cancer, run by ALTality, Inc. 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 3 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Primary; Percent of enrolled patients who activated/used the app during the PACU stay (time frame: immediately after the intervention/procedure/surgery). 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 NCT06635434, which also lists 2 linked publications.
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 26 Oct 2024.