Effects of Weighted Blankets on Anxiety for Pediatric Oncology Patients During Outpatient Chemotherapy Infusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Children's Anxiety Meter-State (CAM-S) assessment
研究概览
简要总结
The use of weighted blankets has been studied in the adult population but there is a lack of evidence to determine their benefit among a pediatric population, specifically oncology pediatric patients. Pediatric oncology patients routinely experience anxiety during therapy and as cure rates increase, attention has progressively turned to treating psychosocial aspects of care.
详细描述
A randomized 2x2 cross-over design will be utilized for this study. The study team will randomize participants to one of two sequences: 1) weighted blanket first then usual care or 2) usual care first then weighted blanket. The cross-over design allows the researchers to compare both within and between group differences. The advantages of the cross-over design allow minimize potential confounding bias as patients will serve as their own controls as well as potential for adequate power with smaller patient enrollment. As this study is conducted during chemotherapy treatments, the 30-day period in between patient treatments will be considered the washout period. This timeframe between chemotherapy infusions was chosen to try to capture patients in a similar state of baseline anxiety. This helps to provide adjustments to variability but should not limit accrual based on the number of patients that get chemotherapy within a 30-day period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed pediatric oncology patients between the ages of 4 and 17 receiving outpatient chemotherapy infusions in one of the two designated out patient locations (Anschutz Campus and Colorado Springs Hospital)
- •Patients who have a "liquid tumor" (leukemia or lymphoma), "solid tumor", or a neuro-oncologic diagnosis
- •Patients who can complete the CAM-S and CAM-T as proven by seriation screening.
- •Patients who are great than 13.5kg in weight, due to weighted blanket size options
- •Patients whose second and third outpatient chemotherapy occur within 30 days of each other.
- •English and Spanish speaking
排除标准
- •Patients who are younger than 4 years of age, or older than 17 years of age
- •Relapsed patients
- •Patients who are undergoing bone marrow transplant or had a previous bone marrow transplant
- •Patients receiving chemotherapy infusions at North Campus and South Campus locations
- •Patients in the inpatient setting
- •Patients who utilize a weighted blanket at home currently or previously
- •Patients who fail seriation screening during enrollment
- •Patients who start initial chemotherapy infusions in the outpatient setting
结局指标
主要结局
Children's Anxiety Meter-State (CAM-S) assessment
时间窗: 12 months
The CAM-S is completed by showing the child a picture of a mercury thermometer and asking the child to "Pretend that all of your worried or nervous feelings are in the very bottom down here (point to scale). If you are a little bit worried or nervous, the feelings might come up just a little bit (move finger up). If you are very, very worried, or nervous, the feelings might come up just a little bit (move finger up to the top). Put a line showing how much worry or nervousness you feel right now." This scale is from measured from 1-10. Higher values indicate higher anxiety. The CAM-S will be administered during the following times: prior to infusion start, thirty minutes into the treatment or end of the treatment if \<30 minutes and end of the treatment (see Figure 1).
次要结局
- Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)(12 months)