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O estudo clínico NCT07362615 para Pediatric Cancer Chemotherapy-Related Symptoms Anxiety está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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An AI-Assisted Art Therapy Co-Creation Intervention 60 Randomizado Pediátrico Curto prazo
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07362615 é um estudo intervencionista para Pediatric Cancer Chemotherapy-Related Symptoms Anxiety. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 20 de janeiro de 2026, com o objetivo de incluir 60 participantes. Coordenado por a Universidade de Gazi e deve ser concluído em 20 de maio de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 23 de janeiro de 2026.
Resumo
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...Mostrar mais
Descrição detalhada
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...Mostrar mais
Título oficial
An AI-Assisted Art Therapy Co-Creation Intervention for Symptom Burden, Anxiety, and Emotional Regulation in Pediatric Chemotherapy Patients: A Randomized Controlled Trial
Condições médicas
Pediatric Cancer Chemotherapy-Related Symptoms AnxietyPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:- 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...
Outros IDs do estudo
- 2025-2254
Número NCT
Data de início (real)
2026-01-20
Última atualização postada
2026-01-23
Data de conclusão (estimada)
2027-05-20
Inscrição (estimada)
60
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
pediatric oncology
chemotherapy
AI-assisted intervention
Digital art therapy
chemotherapy
AI-assisted intervention
Digital art therapy
Propósito principal
Cuidados de suporte
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
Nenhuma intervençãoControl Group Received standard care | N/A |
ExperimentalIntervention 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...Mostrar mais |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto
Idade mínima
10 Years
Sexos elegíveis
Todos
- 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
Responsável pelo estudo
Hazal Ozdemir Koyu, Investigador principal, Dr. Research Assistant, Gazi University
Sem dados de contato.