Therapeutic Play on Pain Tolerance and Emotion Regulation in Children Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Emotion Regulation Scale for Children and Adolescents
研究概览
简要总结
The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment.
详细描述
Type of Research: The research is a randomized controlled experimental study. Place and Time of the Research: The research will be carried out at the Pediatric Hematology Clinic of Adana City Training and Research Hospital between April 2024 and June 2026.
Population and Sample of the Research: The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. In this study, G-power prior power analysis was performed to determine the sample size. In the power analysis, it was determined that if the study was conducted with a total of 60 participants in two groups with 30 participants in each group for the t test in independent groups, 80% power could be achieved with a 95% confidence interval at a significance level of 0.05. It was decided to collect data from a total of 66 children by including a 10% backup sample in this number in case of data loss.
Therapeutic game: In the research, a preliminary application will be made first. A special play bag will be created for each child patient, which will not threaten his health and can be disinfected. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment. Therapeutic game 2 days a week for a maximum of 60 minutes. It will be carried out for 4 weeks.
Week 1: It will consist of meeting, building trust, giving information about the sessions, and planning the therapeutic game. After the initial meeting and trust building stages, activities will be held with emotion cards. Week 2: The researcher will carry out activities that will enable the child to express his emotions through puppet making. A puppet with the characteristics desired by the child will be made by the child and the researcher. The shape and appearance of the puppet will be determined by the child.
Week 3: At this stage, after the puppet is completed, the drama will be created and realized through the meaning given to the puppet and the emotions reflected. Emotions will be discussed on the puppet, and the child will be helped to understand, express and analyze his feelings.
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
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 10-18
- •Diagnosed with acute lymphoblastic leukemia
- •Those receiving chemotherapy treatment
- •Children who do not have a chronic disease other than the diagnosis of the disease in question
排除标准
- •Under 10 years of age or over 18 years of age
- •Diagnosed other than acute lymphoblastic leukemia
- •Not receiving chemotherapy treatment
- •Children with chronic diseases other than the diagnosis of the disease in question
结局指标
主要结局
Emotion Regulation Scale for Children and Adolescents
时间窗: 12 months
The scale was adapted to Turkish in 2021. The scale is a self-rating scale created to evaluate the differences in the use of two emotion regulation strategies. The scale consists of two subscales, reappraisal and suppression, and 10 items. Evaluation is made with a 5-point Likert type rating. Items 1, 3, 5, 7, 8, and 10 of the reevaluation subscale; Items 2, 4, 6, and 9 represent the suppression subscale. High scores obtained from the subscales indicate that the emotion regulation strategy represented by the subscale is frequently used.
Pain Tolerance Scale for Children with Cancer
时间窗: 12 months
The scale was created to develop a tool to measure psychological acceptance in children experiencing pain during cancer treatment. The test version of the scale was conducted on children between the ages of 7 and 18 who were receiving cancer treatment. The Turkish reliability and validity study of the scale was conducted and it was found suitable for use in Turkish children with cancer. The scale is a 7-point Likert type scale consisting of 20 items (0 = strongly disagree and 6 = strongly agree). Some items in the scale (1, 2, 3, 5, 6, 7, 8, 9, 11, 13, 14, 15, 16, 18, 20 items) are reverse coded. The minimum score to be obtained from the scale is 0 and the maximum score is 120. Increasing scale scores indicate an increase in the level of acceptance.
次要结局
未报告次要终点
研究者
ARZU SARIALİOĞLU
Principal Investigator
Ataturk University