The Impact of Weighted Blanket Administration for Acute Pain in Trauma Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
The purpose of this study is to determine whether the use of a weighted blanket improves pain and anxiety among adult trauma inpatients. Participants will be randomly assigned to receive either a weighted blanket or the standard hospital blanket routinely provided during hospitalization. Pain scores documented as part of routine clinical care and participant-reported anxiety ratings will be compared between groups. This study will evaluate whether weighted blankets may serve as a non-pharmacologic adjunct to pain and anxiety management for adult trauma inpatients.
详细描述
This study is a prospective, single-center, randomized controlled trial evaluating weighted blanket use as a non-pharmacologic intervention for adult trauma inpatients admitted to Dell Seton Medical Center.
Eligible participants who provide written informed consent will be randomized in a 1:1 ratio to receive either a commercially available weighted blanket or the standard hospital blanket routinely provided during hospitalization. Participants in both groups will otherwise receive routine clinical care. Assigned blankets will be provided according to randomized group assignment, and participants may use or discontinue use of their assigned blanket at their discretion.
Study data will be collected through review of the electronic medical record and participant-reported assessments. Pain outcomes will be evaluated using Numeric Pain Rating Scale (NPRS) scores documented as part of routine clinical care. Anxiety will be assessed using a daily Visual Analog Scale (VAS) during the first seven study days following enrollment or until hospital discharge, whichever occurs first. Additional study measures include opioid utilization, vital signs, length of hospital stay, and participant-reported blanket use and satisfaction.
Approximately 50 participants are expected to be enrolled. Study data will be analyzed to compare outcomes between the study groups and evaluate weighted blanket use as a non-pharmacologic adjunct to pain and anxiety management in adult trauma inpatients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 89 years
- •Patients admitted to the trauma service at Dell Seton Medical Center
- •Glasgow Coma Scale (GCS) score of 15 at the time of enrollment
- •Able to provide informed consent and participate in study assessments
- •Medically stable for participation, as documented in the electronic medical record and/or confirmed by the treating clinical team
排除标准
- •Age younger than 18 years
- •Age older than 89 years
- •Pregnant patients
- •Intubated or mechanically ventilated patients
- •Patients with burn injuries
- •Prisoners or incarcerated individuals
研究组 & 干预措施
Weighted Blanket
Participants randomized to this arm will receive a commercially available weighted blanket during hospitalization. Participants will otherwise receive routine trauma care. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time. The weighted blanket is considered investigational for this study purpose and is being evaluated for its effect on pain and anxiety in trauma inpatients.
干预措施: Weighted Blanket (Device)
Standard Hospital Blanket
Participants randomized to this arm will receive the standard hospital blanket routinely provided during hospitalization. Participants will otherwise receive routine trauma care. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time. Blankets are laundered and reused according to routine hospital practice.
干预措施: Standard Hospital Blanket (Device)
结局指标
主要结局
Pain Intensity
时间窗: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
Pain intensity will be assessed using routinely documented Numeric Pain Rating Scale (NPRS) scores collected from the electronic medical record as part of standard clinical care, typically every 6 to 8 hours. The NPRS ranges from 0 to 10, with higher scores indicating greater pain intensity. For each participant, all available NPRS scores within each 24-hour study period following enrollment/randomization will be averaged to calculate one average daily pain score.
次要结局
- Anxiety(Everyday for up to the first 7 study days following enrollment/randomization, or until hospital discharge, participant withdrawal, or loss of capacity to continue participation, whichever occurs first.)
- Opioid Utilization(Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first)
- Length of Hospital Stay(From hospital admission through hospital discharge; assessed once at discharge.)
- Average Daily Systolic Blood Pressure(Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first)
- Average Daily Diastolic Blood Pressure(Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first)
- Average Daily Heart Rate(Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first)
- Average Daily Temperature(Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first)
- Average Daily Respiratory Rate(Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first)
- Blanket Use Frequency(Once, on the day of hospital discharge or within 24 hours prior to discharge.)
- Typical Duration of Blanket Use(Once, on the day of hospital discharge or within 24 hours prior to discharge.)
- Reasons for Not Using the Blanket(Once, on the day of hospital discharge or within 24 hours prior to discharge.)
- Overall Blanket Satisfaction(Once, on the day of hospital discharge or within 24 hours prior to discharge.)
- Preference for Future Blanket Availability(Once, on the day of hospital discharge or within 24 hours prior to discharge.)
研究者
Carlos Brown
Professor, Department of Surgery and Perioperative Care
University of Texas at Austin