임상 레이더 AI
임상시험 NCT07362615은(는) Pediatric Cancer Chemotherapy-Related Symptoms Anxiety에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰

An AI-Assisted Art Therapy Co-Creation Intervention 60 무작위 배정 소아 단기

대상자모집전
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07362615은(는) Pediatric Cancer Chemotherapy-Related Symptoms Anxiety에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 1월 20일부터 참여 신청이 가능합니다. 60명의 참여자를 모집할 예정입니다. 가지 대학교이(가) 진행하는 이 연구는 2027년 5월 20일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 1월 23일에 갱신되었습니다.
간단한 개요
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...더 보기
상세한 설명
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...더 보기
공식 제목

An AI-Assisted Art Therapy Co-Creation Intervention for Symptom Burden, Anxiety, and Emotional Regulation in Pediatric Chemotherapy Patients: A Randomized Controlled Trial

질환명
Pediatric Cancer Chemotherapy-Related Symptoms Anxiety
출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.
  • 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...
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기타 연구 식별자
  • 2025-2254
NCT 번호
실제 연구 시작일
2026-01-20
최신 업데이트 게시
2026-01-23
예상 연구 완료일
2027-05-20
계획된 등록 인원
60
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
pediatric oncology
chemotherapy
AI-assisted intervention
Digital art therapy
주요 목적
지지요법
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
비개입Control Group
Received standard care
해당 없음
실험적Intervention 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...더 보기
주요결과변수
결과변수측정값 설명시간 범위
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
이차결과변수
결과변수측정값 설명시간 범위
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
참여 도우미
적격성 기준

연령대
어린이, 성인
최소 연령
10 Years
참여 가능한 성별
전체
  • 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
Gazi University logo가지 대학교
연구 책임자
Hazal Ozdemir Koyu, 책임연구자, Dr. Research Assistant, Gazi University
연락처 정보가 없습니다.