The Effect of Music Therapy on Nausea, Vomiting and Anxiety Levels in Children Diagnosed With Oncological Cancer Receiving Cisplatin: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Pediatric Rhodes Nausea and Vomiting Scale Adapted for Children:
研究概览
简要总结
This study will be conducted with a randomized controlled study model to examine the effect of music therapy on nausea, vomiting and anxiety levels in children diagnosed with oncological cancer receiving cisplatin.
The research is planned to be carried out at Dokuz Eylül University Nevvar-Salih İşgören Children's Hospital Pediatric Hematology-Oncology Clinic between December 2023 and December 2024. There is no application for music therapy in the operation of this hospital and clinic.
详细描述
This study was planned to be conducted with children aged 7-18 years old who were hospitalized in the Pediatric Oncology Clinic of Dokuz Eylül University Hospital Nevvar-Salih İşgören Children's Hospital. The sample calculation required for the study was based on a significance level of 0.05, a power of 80% and an effect size of 0.15 (medium effect size) in the GPOWER 3.1 statistical analysis program. It was determined that 33 children should be included in each group for t test analysis in dependent groups. In order to fulfill the parametric test assumptions in the study and considering the 10% loss, it was planned to include 40 children in the experimental group and 40 children in the parent and control group, who voluntarily agreed to participate in the research, for a total of 80 children.
Children with cancer who are between the ages of 7-18, receive cisplatin treatment, are diagnosed with oncological cancer, do not have mental retardation as a clinical diagnosis, receive chemotherapy during their stay in the clinic, have no hearing problems, know how to read and write in Turkish, and volunteer to participate in the study will be included in the study. . Children with cancer who are in the terminal stage and do not want to participate in the study will not be included in the study.
Data Collection Process Children who will receive the intervention and their parents will be informed about the research. Children and their parents will be informed about the music therapy to be applied to their children and their verbal and written consent will be obtained. After consent is obtained, it will be determined which group the child belongs to by randomization method. The standard approach will be applied to all children.
Standard approach; Granisetron IV 40mcg/kg/24, Aprepitant PO 125 mg/24 hour and Dexamethasone 6 mg/m2 IV/PO are administered to children receiving cisplatin treatment.
The child in the control group will not undergo any additional intervention, and the standard antiemetic treatment procedure will be applied 15 minutes before the cisplatin infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those between the ages of 7-18,
- •Receiving Cisplatin Treatment, Diagnosed with Oncological Cancer,
- •Without Mental Retardation as a Clinical Diagnosis,
- •Those who received chemotherapy during their stay in the clinic,
- •No Hearing Problems,
- •Able to Read and Write Turkish,
- •Children with Cancer who Volunteer to Participate in the Research
排除标准
- •Children with cancer who are in the terminal period and do not want to participate in the study will not be included in the study.
结局指标
主要结局
Pediatric Rhodes Nausea and Vomiting Scale Adapted for Children:
时间窗: one year
ARINVc was first developed for adult oncology patients by Rhodes and later adapted to children by Lo and Hayman. The validity and reliability study of the scale was conducted by Akçay and his colleagues in the Turkish population in 2018. The scale consists of five statements for each of 6 items measuring the child's frequency, duration and distress of nausea, frequency of vomiting and distress in the last 12 hours and is scored between 0 and 4. ARINVc consists of 6 items. The first three items in the scale question the frequency, amount, and distress caused by vomiting during the last 12 hours, and the remaining three items question the frequency, duration, and distress caused by nausea.
Nausea Vomiting Thermometer for Children with Cancer
时间窗: one year
It is a visual scale that measures nausea and vomiting developed by Kudubeş and Bektaş in 2022. The scale is thermometer-shaped and has five degrees. It is visualized as a smiling face (1), unresponsive face (2), sad face (3), sad face (4) and crying face (5). Additionally, as the scale score increases, the facial expression on the scale changes. It is scored as never (1), rarely (2), sometimes (3), often (4) and always (5). The lowest score from the scale is 1 and the highest score is 5. An increase in the scale score indicates that the child's degree of nausea and vomiting increases. The intraclass correlation coefficient of the scale is 0.99.
Child and Parent Information Form
时间窗: one year
The form, created by the researchers using the literature, consists of 22 questions indicating the child's age, gender, diagnosis, treatment method, medication use other than chemotherapy, medications used, parent's age, parent's education, income and employment status, and characteristics of the child's care and treatment.
State-Trait Anxiety Scale for Children
时间窗: one year
The scale was developed by Spielberger in 1973. Its Turkish validity and reliability was conducted by Özusta in 1995 (Özusta, 1995). In the State Anxiety Scale of ÇDSCI, children are asked to evaluate how they feel 'at that moment' and to mark one of three relevant options. The scale, consisting of 20 items, aims to evaluate emotions related to state anxiety such as tension, irritability, and uneasiness. If the child reports the presence of these feelings as a lot, the highest score is 3, and if the child reports that they do not exist, the lowest score is 1.
次要结局
未报告次要终点
研究者
Fulya Kos
lecturer
Bilecik Seyh Edebali Universitesi