The Effect of Child-centered Empowerment on Lifestyle of Leukemia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Lifestyle Scores
研究概览
简要总结
This randomized clinical trial aimed to evaluate the effectiveness of a child-centered empowerment model in improving the lifestyle of children with leukemia. The study focused on whether structured empowerment interventions could significantly enhance daily habits and overall well-being in pediatric oncology patients. The main research questions were:
Does the child-centered empowerment model improve the lifestyle of children with leukemia? Can this complementary and non-invasive method be considered a viable approach for supporting pediatric care?
Participants (N = 46) aged 7-13 years were randomly assigned to either the intervention group, which received empowerment training in four dimensions (perceived threat, self-efficacy, educational participation, and evaluation), or the control group, which received routine care. Pre- and post-intervention assessments were conducted using a validated lifestyle questionnaire measuring nutrition, sleep, physical activity, physical health, and stress.
详细描述
Study Title:
The Effect of Child-Centered Empowerment on the Lifestyle of Children with Leukemia
Study Purpose:
The aim of this study was to investigate the efficacy of a child-centered empowerment model in improving the lifestyle of pediatric patients with leukemia. The intervention was designed to strengthen coping abilities, promote healthier daily habits, and enhance overall well-being, in line with holistic and family-centered nursing principles. The study was conducted as a double-blind randomized clinical trial.
Sample Size Determination:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Double-Blind (Investigator, Outcomes Assessor):
To minimize bias, a double-blind approach was employed. The researcher responsible for data collection was unaware of the group assignments, and the statistician analyzing the results was also blinded to the allocation. The data were processed under masked labels (x1 and x2) to preserve objectivity.
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7-13 years diagnosed with leukemia and admitted to the pediatric oncology clinic.
- •Children and parents willing to participate in the study and provide written informed consent (parents) and assent (children).
- •No reported history of specific mental disorders as declared by parents.
排除标准
- •Inconsistent participation in empowerment sessions (e.g., missing scheduled intervention sessions).
- •Withdrawal from the study by the child or family at any time. Any condition preventing the child from completing questionnaires or participating in group discussions.
研究组 & 干预措施
Child-Centered Empowerment
Behavioral: Child-Centered Empowerment Intervention
Participants in this group receive the child-centered empowerment program, a structured behavioral intervention designed to enhance coping skills, promote self-efficacy, and improve lifestyle in children with leukemia. The program is based on four dimensions of empowerment:
Perceived Threat: Increasing awareness of illness, its complications, and the treatment process through group discussions.
Self-Efficacy: Practicing problem-solving and self-management techniques to strengthen self-belief, self-control, and confidence in handling illness-related challenges.
Educational Participation: Children receive educational cards at the end of each session and are encouraged to share the learned content with family members to reinforce responsibility and engagement.
Evaluation: Continuous follow-up and assessment of learning after each session to ensure understanding and active participation.
干预措施: Child-Centered Empowerment Intervention (Behavioral)
Routine Care
Participants in this group continue with their usual oncology care and do not receive any additional empowerment training. Routine medical and nursing care is delivered according to standard clinical practice without structured behavioral interventions
结局指标
主要结局
Lifestyle Scores
时间窗: Lifestyle scores are measured at two time points - baseline (before the intervention) and one month after completion of the empowerment program
The primary outcome measure evaluates changes in the lifestyle of children with leukemia. Lifestyle is assessed using a validated lifestyle questionnaire covering five domains: nutrition, sleep, physical activity, physical health, and stress. The tool includes 38 items rated on a 4-point Likert scale ("often" to "never"), with higher scores indicating a more favorable lifestyle.
次要结局
未报告次要终点
研究者
Pouran Varvani Farahani
PhD in Pediatric Nursing, Department of Nursing, Faculty of Health Science, Cyprus International University,
Near East University, Turkey