Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting in Pediatric Oncology Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Nausea and vomiting
研究概览
简要总结
The goal of this randomized controlled study is to assess the effect of guided imagery on chemotherapy-related nausea and vomiting in pediatric oncology patients.
Participants will receive either guided imagery+routine care or routine care. The researchers will compare nausea and vomiting and vital signs between groups.
详细描述
Despite significant advances in anti-emetic treatment, chemotherapy induced nausea and vomiting (CINV) is considered a major side-effect that significantly reduces the quality of life of children diagnosed with cancer. Guided imagery is one of the methods of distraction that allows the individual to go to an environment or scene that will make the individual comfortable, peaceful, happy, and focused. In this study, the participants will be randomized in a single blind manner (participant) to either intervention or control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant will be randomly assigned to groups. An independent statistician will analyze the data.
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
- 否
入选标准
- •7 to 18 years old,
- •who will receive intravenous chemotherapy,
- •no cognitive or neurological disease that would prevent communication,
- •receiving a chemotherapy protocol with a high or moderate emetogenic effect according to the MASCC/ESMO Antiemetic Guideline Classification,
- •no verbal, visual and auditory communication disabilities (ability to speak Turkish, no mental deficiency),
- •children whose parents and themselves volunteered to participate in the study
排除标准
- •Children receiving radiotherapy,
- •taking ginger powder or vitamins to reduce nausea,
- •children who did not want to participate in the study
研究组 & 干预措施
Guided imagery group
Participants will receive guided imagery intervention.
干预措施: guided imagery (Other)
Control
Participants will receive routine care.
结局指标
主要结局
Nausea and vomiting
时间窗: 30 minutes before the procedure, halfway through the chemotherapy infusion, immediately after the procedure, and for the first 24 hours after the end of chemotherapy
Nausea and Vomiting Thermometer Scale in Children with Cancer is a 5-likert type scale. An increase in the score indicates an increase in the degree of nausea and vomiting experienced by children with cancer.
次要结局
- Heart rate(30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure,)
- Systolic and diastolic blood pressure(30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure)
- Respiratory rate(30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure)
- Body temperature(30 minutes before the procedure, halfway through the chemotherapy infusion, and immediately after the procedure)
- Oxygen saturation(change from baseline 60 minutes of chemotherapy infusion)
研究者
Ayşe Ay
RN, PhD, Assistant Professor
Baskent University