The Effect of Music Intervention on Anxiety, Fear, and Pain in Pediatric Patients Receiving Intrathecal Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- anxiety
研究概览
简要总结
Intrathecal chemotherapy is often used to prevent the spread of cancer to the central nervous system in pediatric patients and is one of the most invasive procedures. It is believed that the way it is administered and the complications experienced after treatment negatively affect the comfort of the pediatric patient, leading them to refuse the treatment.
详细描述
Receiving sedation is one of the pharmacological procedures for intrathecal chemotherapy which creates a particularly difficult situation for the child. However, since pharmacological methods increase the cost and cause toxicity in children, in recent years, the symptoms that occur in cancer treatment have been tried to be controlled with non-pharmacological methods. Music intervention facilitates a sense of control in patients and provides mental distraction, emotional smoothness, and relaxation, which have been found to have pain relief effects.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be between 6-12 years old,
- •Being treated in the Hematology and Oncology Clinic,
- •About to receive intrathecal chemotherapy treatment,
- •The child not having pain before intrathecal chemotherapy treatment
排除标准
- •Refusing to participate in the study,
- •Being under 6 years of age and over 10 years of age,
- •The child having pain prior to intrathecal chemotherapy treatment,
- •Having any physical or mental disability,
- •Not being able to speak Turkish.
结局指标
主要结局
anxiety
时间窗: 30 minutes before intrathecal chemotherapy treatment and just after music intervention
Child Anxiety Meter-State (CAM-S):The scale can be scored between 1 and 10. An increase in the score means an increase in anxiety.
fear
时间窗: 30 minutes before intrathecal chemotherapy treatment and just after music intervention
Children's Fear Scale (CFS): The scale can be scored between 0 and 4. An increase in the score means an increase in fear
pain scale
时间窗: 60 minutes after intrathecal chemotherapy treatment
Face, Legs, Activity, Cry, Consolability pain scale (FLACC): total score between 0 and 10 is obtained by assigning 0, 1, or 2 points for each category. As the severity of pain increases, the total score increases, and as the severity of pain decreases,
次要结局
未报告次要终点
研究者
Hatice Uzşen
Research assistant
Ondokuz Mayıs University