Art-Based Emotion Regulation Program
ConditionChildren With Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorGazi University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Art-Based Emotion Regulation Program
Other interventionThe 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, participants receive a guided progressive muscle relaxation exercise delivered via video, with the initial session conducted together with the researcher. Participants are then instructed to practice the relaxation exercise at least twice per week throughout the intervention period. Emotion-color mapping activities are conducted during weeks 1 to 3, allowing adolescents to visually express emotions and treatment-related symptoms using colors and drawings. Changes in emotional states and symptom intensit
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: rt-Based Emotion Regulation ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
State Anxiety Inventory for Children (SAIC)
The State Anxiety Inventory for Children (SAIC) was developed by Spielberger (1973) to assess situational anxiety levels in children and adolescents. The Turkish validity and reliability study was conducted by Özusta (1995). The scale consists of 40 items, including 20 items measuring state anxiety and 20 items measuring trait anxiety. In this study, only the State Anxiety subscale is used to evaluate the child's current feelings of anxiety. Total scores range from 20 to 60, with higher scores indicating higher anxiety levels. The original scale demonstrated Cronbach's alpha values between 0.78 and 0.81, while the Turkish version reported a Cronbach's alpha of 0.82 for the state anxiety subscale. The scale has been widely used among children and adolescents aged 9-18 years in Turkey.
Time frame
Baseline (pre-intervention) and immediately post-intervention (at the end of the 4-week intervention period).2
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) was originally developed by Gullone and Taffe (2012) and adapted into Turkish by Tetik and Önder (2021). The scale is a self-report measure designed to assess differences in emotion regulation strategies among children aged 10-18 years. It consists of 10 items and includes two subscales: Cognitive Reappraisal (6 items) and Expressive Suppression (4 items). Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate more frequent use of the corresponding emotion regulation strategy. The Turkish version demonstrated good internal consistency, with Cronbach's alpha values of 0.83 for the reappraisal subscale and 0.75 for the suppression subscale.
Time frame
Baseline (pre-intervention) and immediately post-intervention (at the end of the 4-week intervention period).3
Symptom Screening in Pediatrics Tool (SSPedi)
The Symptom Screening in Pediatrics Tool (SSPedi) is a validated instrument developed to assess symptom burden in children aged 8-18 years undergoing cancer treatment. The original validity and reliability study for the electronic version was conducted by O'Sullivan et al. (2018), reporting a Cronbach's alpha coefficient of 0.88. The tool evaluates 15 common symptoms experienced by children over the past two days, with each symptom rated using a 5-point Likert scale. Total scores range from 0 to 60, with higher scores indicating greater symptom burden and distress. The Turkish validity and reliability study was conducted by Çelik et al. (2021).
Time frame
Baseline (pre-intervention) and immediately post-intervention (at the end of the 4-week intervention period).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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