رادار التجارب AI
حالة التجربة السريرية NCT07362615 لـ Pediatric Cancer Chemotherapy-Related Symptoms Anxiety هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة

An AI-Assisted Art Therapy Co-Creation Intervention ٦٠ عشوائية طب الأطفال قصير الأمد

لم يبدأ القبول بعد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07362615 هي دراسة تدخُّلية لـPediatric Cancer Chemotherapy-Related Symptoms Anxiety وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١ شعبان ١٤٤٧ هـ لتجنيد ٦٠ مشاركًا. يقودها جامعة غازي، ومن المتوقع اكتمالها بحلول ١٤ ذو الحجة ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٤ شعبان ١٤٤٧ هـ.
الملخص
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...عرض المزيد
وصف مفصل
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...عرض المزيد
العنوان الرسمي

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

الحالات الطبية
Pediatric Cancer Chemotherapy-Related Symptoms Anxiety
المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:
  • 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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معرّفات دراسة أخرى
  • 2025-2254
NCT معرّف
تاريخ البدء (فعلي)
2026-01-20
آخر تحديث مُنشور
2026-01-23
تاريخ الاكتمال (المقدر)
2027-05-20
عدد المشاركين المخطط لهم
٦٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
pediatric oncology
chemotherapy
AI-assisted intervention
Digital art therapy
الغرض الأساسي
الرعاية الداعمة
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
بدون تدخلControl Group
Received standard care
غ/م
تجريبيةIntervention 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...عرض المزيد
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
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
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
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
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
طفل, بالغ
العمر الأدنى للدراسة
10 Years
الجنس المؤهل
الكل
  • 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 logoجامعة غازي
الجهة المسؤولة عن الدراسة
Hazal Ozdemir Koyu, المحقق الرئيسي, Dr. Research Assistant, Gazi University
لا توجد بيانات اتصال.