Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT07362615 per Pediatric Cancer Chemotherapy-Related Symptoms Anxiety è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
An AI-Assisted Art Therapy Co-Creation Intervention 60 Randomizzato Pediatrico Breve termine
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07362615 è uno studio interventistico per Pediatric Cancer Chemotherapy-Related Symptoms Anxiety, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 20 gennaio 2026, con l'obiettivo di raggiungere 60 partecipanti. Sotto la guida di l'Università Gazi, dovrebbe concludersi entro il 20 maggio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 23 gennaio 2026.
Sommario breve
This randomized controlled trial aims to evaluate the effects of an AI-assisted interactive art therapy co-creation intervention on symptom burden, state anxiety, and emotional regulation in pediatric patients receiving chemotherapy. The study will be conducted as a parallel-group randomized controlled trial at the Pediatric Hematology-Oncology units of Gazi University Health Application and Research Center between F...Mostra di più
Descrizione dettagliata
Childhood cancer and its treatment are associated with significant physical and psychological symptom burden, particularly during chemotherapy. Children frequently experience multiple concurrent symptoms such as nausea, pain, fatigue, and sleep disturbances, accompanied by heightened anxiety and emotional distress. These challenges highlight the need for brief, feasible, and developmentally appropriate psychosocial i...Mostra di più
Titolo ufficiale
An AI-Assisted Art Therapy Co-Creation Intervention for Symptom Burden, Anxiety, and Emotional Regulation in Pediatric Chemotherapy Patients: A Randomized Controlled Trial
Patologie
Pediatric Cancer Chemotherapy-Related Symptoms AnxietyPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:- 1. Chen, Y., Chen, X., Li, L., Li, Y., Yan, Q., & Hu, X. (2025). The efficacy of virtual reality-based interventions on pain, anxiety, depression, and quality of life among patients with cancer: a meta-analysis of randomized controlled trials. Cancer Nursing, 10.1097. 2. Çelik, R., Törüner, E. K., Altay, N., & Bayram, D. (2024). The Validity-Reliability Study of Turkish V...
Altri ID dello studio
- 2025-2254
Numero NCT
Data di inizio (effettiva)
2026-01-20
Ultimo aggiornamento pubblicato
2026-01-23
Data di completamento (stimata)
2027-05-20
Arruolamento (previsto)
60
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Parole chiave
pediatric oncology
chemotherapy
AI-assisted intervention
Digital art therapy
chemotherapy
AI-assisted intervention
Digital art therapy
Scopo principale
Terapia di supporto
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Nessun interventoControl Group Received standard care | N.D. |
SperimentaleIntervention Group Participating in an AI-powered art-based program | AI-based art-based program The intervention is an AI-assisted interactive art therapy co-creation program designed to support symptom management, emotional regulation, and anxiety reduction in pediatric patients undergoing chemotherapy. The program is delivered individually during the first 1-4 days of a new chemotherapy cycle and consists of four consecutive daily sessions, each lasting approximately 20-30 minutes.
The intervention integrate...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Emotional Regulation | Emotional regulation will be assessed using the Emotion Regulation Questionnaire for Children and Adolescents. This self-report scale evaluates the use of emotional regulation strategies across two subscales: cognitive reappraisal and expressive suppression. The scale consists of 10 items rated on a 5-point Likert scale. Higher subscale scores indicate more frequent use of the corresponding emotional regulation strategy. | Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period |
Symptom Burden | Symptom burden will be assessed using the Symptom Screening in Pediatrics Tool (SSPedi), a validated self-report instrument for children aged 8-18 years undergoing cancer treatment. The scale includes 15 common physical and psychological symptoms experienced during chemotherapy. Each item is rated on a 5-point Likert scale, with total scores ranging from 0 to 60. Higher scores indicate greater symptom burden and distress. | Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period |
State Anxiety | State anxiety will be measured using the State Anxiety Inventory for Children, a 20-item self-report scale designed to assess situational anxiety levels in children and adolescents aged 8-18 years. Items are rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores reflect higher levels of state anxiety. | Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Intervention Acceptability | Intervention acceptability and participant satisfaction will be assessed using a researcher-developed process evaluation form. Children will rate their perceived comfort, enjoyment, and satisfaction with the intervention on a numeric scale ranging from 0 to 5, with higher scores indicating greater acceptability. | Immediately after completion of the intervention |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Bambino, Adulto
Età minima
10 Years
Sessi idonei
Tutti
- Be between 10 and 18 years of age
- Have been receiving chemotherapy treatment for at least 6 months
- Be between days 1 and 4 of a new chemotherapy cycle
- Be able to communicate in Turkish
- Be clinically stable
- The participant and their parent/guardian must consent to participate in the study and provide written consent
• Severe neurocognitive impairment, severe physical instability, or being under sedation
- Experiencing a severe traumatic life event unrelated to the disease within the last 6 months
- Being in the terminal phase clinically
- Being under clinical observation due to a psychiatric diagnosis
- Having fatigue, pain, or medical complications that would prevent participation in the intervention
Parte responsabile dello studio
Hazal Ozdemir Koyu, Investigatore principale, Dr. Research Assistant, Gazi University
Nessun dato di contatto