Art-Based Emotion Regulation Program

Официальное название

The Effect of an Art-Based Emotion Regulation Program on Anxiety, Emotion Regulation Skills, and Symptom Burden in Adolescents Undergoing Cancer Treatment: A Randomized Controlled Trial

Обзор

Adolescents receiving cancer treatment often experience increased anxiety, difficulties in emotion regulation, and a high symptom burden due to treatment-related physical effects and psychosocial stressors. Supportive, non-pharmacological interventions that promote emotional regulation are therefore needed. The purpose of this randomized controlled trial is to evaluate the effect of an art-based emotion regulation program on anxiety levels, emotion regulation skills, and symptom burden in adolescents undergoing cancer treatment. This single-blind, parallel-group randomized controlled study will include 60 adolescents aged 10-18 years receiving cancer treatment at Gazi University Health Application and Research Center and Etlik City Hospital Pediatric Hematology-Oncology units between January 30, 2026 and March 20, 2027. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive a 4-week art-based emotion regulation program, while the control group will receive routine care. Outcomes will be assessed using validated self-report measures at baseline and at the end of the intervention period.

Подробное описание

Adolescents undergoing cancer treatment frequently experience a combination of physical symptoms and psychosocial stressors that negatively affect their emotional well-being, anxiety levels, and ability to regulate emotions. Difficulties in emotion regulation may intensify perceived symptom burden and interfere with treatment adherence and overall quality of life. Art-based interventions offer developmentally appropriate, expressive, and non-invasive strategies to support emotional regulation in this population.

This study is designed as a single-blind, parallel-group randomized controlled trial to examine the effectiveness of an art-based emotion regulation program in adolescents receiving cancer treatment. The study will be conducted between January 30, 2026 and March30, 2027 at the Pediatric Hematology-Oncology units of Gazi University Health Application and Research Center and Etlik City Hospital.

A total of 60 adolescents aged 10-18 years who have been receiving cancer treatment for at least six months will be enrolled and randomly assigned to either the intervention group (n=30) or the control group (n=30). Stratified block randomization based on age and gender will be performed by an independent statistician using an online randomization tool. Outcome assessors will be blinded to group allocation.

The intervention group will participate in a 4-week art-based emotion regulation program consisting of progressive muscle relaxation exercises, emotion-color mapping activities, and gratitude mandala practices. During the first week, adolescents will receive a progressive muscle relaxation video and complete the first session together with the researcher. They will then be asked to practice the exercise at least twice weekly throughout the program. Emotion-color mapping activities will be conducted during weeks 1-3 to help adolescents visually express and monitor changes in emotional states and symptom intensity. In the second week, a gratitude mandala activity will be added to enhance awareness of positive emotions. Weekly follow-up discussions will be conducted to support engagement and reflection. In the fourth week, relaxation exercises will continue, emotion-color maps will be reviewed for change, and post-test assessments will be completed.

The control group will receive routine hospital care without any additional intervention. Both groups will complete the same assessment tools at baseline and at the end of the fourth week.

Primary and secondary outcomes will be measured using the State Anxiety Inventory for Children, the Emotion Regulation Questionnaire for Children and Adolescents, and the Pediatric Symptom Screening Tool (SSPedi). The findings of this study are expected to provide evidence for the effectiveness of art-based emotion regulation interventions as a supportive, feasible, and non-pharmacological approach in adolescent oncology care.

Вмешательства

• Другое Art-Based Emotion Regulation Program
  The Art-Based Emotion Regulation Program is a structured, non-pharmacological intervention designed to support emotional regulation and reduce anxiety and symptom burden in adolescents undergoing cancer treatment. The program is delivered over a 4-week period and combines relaxation techniques with expressive art-based activities. The intervention includes progressive muscle relaxation exercises, emotion-color mapping activities, and gratitude mandala practices. During the first week, participa

Первичные конечные точки

• State Anxiety Inventory for Children (SAIC) [Срок оценки: Baseline (pre-intervention) and immediately post-intervention (at the end of the 4-week intervention period).]
• Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) [Срок оценки: Baseline (pre-intervention) and immediately post-intervention (at the end of the 4-week intervention period).]
• Symptom Screening in Pediatrics Tool (SSPedi) [Срок оценки: Baseline (pre-intervention) and immediately post-intervention (at the end of the 4-week intervention period).]

Критерии участия

• Inclusion Criteria for the Study:

• Receiving cancer treatment for at least 6 months,
• Aged between 10 and 18 years,
• The participant and their parent/guardian consent to participate in the study and provide written informed consent.

Критерии исключения

• Those who have experienced a significant life event (death, relocation, etc.) unrelated to their illness in the last six months,
• Those who have not received chemotherapy treatment,
• Those in the terminal stage,
• Those with a severe psychological diagnosis and taking medication

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 1. Kisecik Sengul, Z., & Kilicarslan, E. (2025). Investigation into the impact of technology-based motivation program applied to children following cancer diagnosis and their families: a randomized controlled study. BMC psychology, 13(1), 857. 2. Lewandowska, A., Lewandowski, T., Bartosiewicz, A., Papp, K., Zrubcová, D., Šupínová, M., Stryjkowska-Góra, A., Laskowska, B., Joniec, G., & Apay, S. E.

Идентификаторы

NCT: NCT07367035 · 2026-64

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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