治験レーダーAI | ||
|---|---|---|
治験 NCT06635434（対象：痛み、小児がん）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
An English/Spanish Mobile Augmented Reality Pain Assessment App for Hispanic/Latino Pediatric Cancer Patients
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06635434 は 痛み、小児がん に関する 医療機器の実現可能性 の研究で、初期第I相・早期第一期 介入研究 臨床試験 です。現在は 実施中／登録終了 で、2023年2月5日 から開始しています。16 名の参加者 の募集が計画されています。この治験は ALTality, Inc. によって主催され、2024年11月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年10月26日 です。
概要
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.
公式タイトル
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
疾患／病気
痛み小児がん刊行物
この臨床試験について発表された科学記事と研究論文：- 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.
- Gaither 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.
その他の研究識別子
NCT番号
開始日
2023-02-05
最終更新日
2024-10-26
終了予定日
2024-11-30
目標参加者数
16
試験の種類
介入研究
治験の相・段階
初期第I相・早期第一期
状況
実施中／登録終了
主目的
医療機器の実現可能性
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Augmented reality-enabled pain assessment deployed on a mobile 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 | AR Pain Assessment 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 |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 | immediately after the intervention/procedure/surgery |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 | immediately after the intervention/procedure/surgery |
Recorded responses about pain assessment from the app | Pain scale score in English or Spanish through the app | 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 | immediately after the intervention/procedure/surgery |
Inpatient opioid consumption | Calculated as morphine equivalent dose of all opioids given | immediately after the intervention/procedure/surgery |
Length of stay | Total time (minutes) spent in the PACU after surgery | immediately after the intervention/procedure/surgery |
Quality of life survey | PedsQL survey administered to child and/or adult caregiver stratified by age | 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 | 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? | immediately after the intervention/procedure/surgery |
適格基準
対象年齢
小児
試験の最低年齢
7 Years
対象性別
全て
- 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.
- 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.
ALTality, Inc.MDアンダーソンがんセンター連絡先情報がありません。
1 1カ国の場所
Texas
MD Anderson Cancer Center, Houston, Texas, 77054, United States