Weighted Blanket Use in Oncology Patients to Reduce Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form
研究概览
简要总结
This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. chemotherapy, targeted therapy etc.) to decrease adverse side effects such as anxiety and distress in cancer (oncology) patients. Feeling safe, comforted, and grounded in the world are some of the benefits noted by individuals who use weighted blankets. Deep touch pressure (DTP) has been found to reduce symptoms of stress and anxiety and is defined as a sensation one feels when being hugged, squeezed, or held. DTP affects the nervous system by creating a calming effect which may lower stress and increase feelings of well-being. The use of weighted blankets may help to manage anxiety and distress during chemotherapy or immunotherapy infusions.
详细描述
PRIMARY OBJECTIVE:
I. To assess the efficacy of weighted blankets on anxiety in patients receiving infusion therapy.
SECONDARY OBJECTIVE:
I. To assess the efficacy of weighted blankets on distress in patients receiving infusion therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of age and older
- •About to begin either targeted or cytotoxic chemotherapy
- •Able to comprehend and sign a consent form
- •Able to read and complete surveys
- •Alert and oriented
排除标准
- •Currently using a weighted blanket at home
- •Non-English speaking
- •Peripheral neuropathy
- •Fibromyalgia
- •Open pressure ulcer
- •Recent surgical flap
- •Claustrophobic
- •Weight 45 kg or less
研究组 & 干预措施
Arm II (regular blanket)
Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.
干预措施: Best Practice (Other)
Arm I (weighted blanket)
Patients use a weighted blanket for 30 minutes during the infusion appointment.
干预措施: Supportive Care (Other)
Arm I (weighted blanket)
Patients use a weighted blanket for 30 minutes during the infusion appointment.
干预措施: Survey Administration (Other)
Arm II (regular blanket)
Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.
干预措施: Survey Administration (Other)
结局指标
主要结局
Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form
时间窗: At baseline and 30 minutes after use of either a standard or weighted blanket
To test for the effect of the weighted blanket, will fit a mixed model with the post-level of anxiety as the dependent variable and baseline values and treatment (standard or weighted blanket) as predictors. A random effect for patient will be fit to account for the possible correlation of within-patient repeated outcome measures. The models will control for patient gender and age.
次要结局
- Qualitative change in levels of distress based on the baseline and 30 min post blanket use scores using NCCN Distress Thermometer(At baseline and 30 minutes after use of either a standard or weighted blanket)
- Levels of distress using NCCN Distress Thermometer(At baseline and 30 minutes after use of either a standard or weighted blanket)
- Qualitative change in levels of anxiety based on the baseline and 30 min post blanket use scores using State Trait Anxiety Inventory (STAI) for Adults, short form(At baseline and 30 minutes after use of either a standard or weighted blanket)
研究者
Allison De Villiers
Principal Investigator
Ohio State University Comprehensive Cancer Center