Effects of a Parent-Child Mandala Painting Intervention During Chemotherapy on Caregiver Burden, Psychological Well-being, and Child Fear and Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Children's Pain Level
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of a parent-child mandala painting intervention conducted during the chemotherapy process on caregiver burden, psychological well-being, and child fear and pain levels in pediatric oncology patients.
Childhood cancer and its treatment are highly stressful experiences for both children and their parents. Chemotherapy-related side effects such as pain, fear, and emotional distress may negatively affect children's psychological well-being and treatment adaptation. Parents, as primary caregivers, often experience increased emotional burden, anxiety, and stress during this process.
The intervention consists of a structured parent-child mandala painting activity delivered over a two-week period, with six sessions in total, each lasting 30 minutes. Participants are randomly assigned to either the intervention group, which receives the mandala painting activity in addition to routine care, or the control group, which receives routine nursing care alone.
Outcome measures include child fear and pain levels assessed using validated pediatric scales, as well as caregiver burden and psychological distress measured through standardized questionnaires. Assessments are conducted at baseline and after completion of the two-week intervention period.
This study seeks to contribute evidence on the use of creative, non-pharmacological interventions to support emotional well-being in children undergoing chemotherapy and their caregivers.
详细描述
This study is designed as a randomized controlled trial to examine the effects of a parent-child mandala painting intervention during the chemotherapy process on caregiver burden, psychological well-being, and child fear and pain levels.
The study population consists of children aged 5-12 years who are receiving chemotherapy treatment in a pediatric hematology-oncology unit and their primary caregivers. Following eligibility screening and informed consent, eligible parent-child dyads are randomly assigned to either the intervention group or the control group using an urn randomization method to ensure equal allocation.
Participants in the intervention group engage in a parent-child mandala painting activity in addition to routine nursing care. The intervention is delivered over a two-week period, consisting of six sessions, each lasting approximately 30 minutes. During each session, children and their parents are provided with mandala coloring sheets and colored markers and are encouraged to paint together in a quiet and supportive hospital environment. The activity aims to promote emotional expression, relaxation, and positive parent-child interaction during chemotherapy.
The control group receives routine nursing care without any additional structured intervention during the same two-week period. After completion of outcome assessments, participants in the control group are also offered the mandala painting activity in accordance with ethical principles.
Primary outcome measures include child fear and pain levels, assessed using the Child Fear Scale and the Wong-Baker Faces Pain Rating Scale. Secondary outcome measures include caregiver burden and psychological distress, measured using the Zarit Caregiver Burden Scale and the Depression Anxiety Stress Scale (DASS-21).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 5 and 12 years who are receiving chemotherapy.
- •One parent or primary caregiver willing to participate with the child.
- •Ability of the child to perform basic fine motor activities such as holding a pencil and coloring.
- •Absence of an acute psychiatric diagnosis in the child (e.g., severe anxiety disorder, psychotic disorders).
- •Willingness of both the child and the parent to participate in the study.
排除标准
- •Children diagnosed with stage III or stage IV cancer.
- •Presence of visual perception impairments in the child (e.g., color blindness, severe visual impairment).
- •Refusal of the child or parent to participate in the study.
研究组 & 干预措施
Control Group
Participants in this arm receive routine nursing care during the chemotherapy process without any additional structured intervention during the study period.
Mandala Painting Group
Participants in this arm receive a structured parent-child mandala painting intervention in addition to routine nursing care during the chemotherapy process. The intervention is delivered over two weeks, consisting of six sessions, each lasting approximately 30 minutes.
干预措施: Parent-Child Mandala Painting Intervention (Behavioral)
结局指标
主要结局
Children's Pain Level
时间窗: Baseline and at the end of the 2-week intervention period
Change in children's pain level measured using the Wong-Baker Faces Pain Rating Scale (WBFPRS), a validated pediatric pain assessment tool consisting of six facial expressions representing increasing pain intensity. The scale is scored from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores represent greater pain intensity.
Children's Fear Level
时间窗: Baseline and at the end of the 2-week intervention period
Change in children's fear level measured using the Children's Fear Scale (CFS), a single-item observational scale designed to assess fear in children. The scale ranges from 0 to 4, where 0 represents "no fear" and 4 represents "extreme fear." Higher scores indicate higher levels of fear.
次要结局
- Caregiver Burden(Baseline and at the end of the 2-week intervention period)
- Parental Psychological Distress(Baseline and at the end of the 2-week intervention period)
研究者
Rıdvan Akdogan
Assist. Prof. (PhD)
Yuzuncu Yil University