A Single-Arm Pilot Study Investigating Weighted Blanket Use for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in self-reported pain intensity
研究概览
简要总结
Chronic pain is a common condition that can affect sleep, daily functioning, and overall quality of life. Many individuals living with chronic pain seek non-medication approaches to help manage their symptoms. Weighted blankets are commonly used to promote relaxation and comfort during sleep, but there is limited research examining their potential role in supporting people with chronic pain.
This pilot study will explore the experiences of adults with chronic pain who use a weighted blanket during sleep. The study aims to better understand whether nightly use of a weighted blanket may be associated with changes in pain, sleep, and daily functioning. Findings from this study will help inform future research on non-medication approaches to managing chronic pain.
Approximately 44 adults with chronic pain will participate in the study. Participation will last about five weeks. After completing a virtual enrollment visit and baseline questionnaires, participants will receive a weighted blanket sized to approximately 10 percent of their body weight.
Participants will first complete a 7-day adjustment period using the blanket while sleeping. If they tolerate the blanket and use it nightly during this period, they will continue into a 4-week study phase in which they will use the weighted blanket each night.
During the study, participants will complete brief online surveys about their experiences and adherence to using the blanket. Pain and quality-of-life questionnaires will be completed at multiple time points, including at the start and end of the study. Participants will also provide feedback about their experience using the weighted blanket.
Results from this pilot study will help researchers better understand how weighted blankets may be used by adults with chronic pain and may help guide the design of future studies evaluating non-pharmacologic approaches to pain management.
详细描述
Chronic pain is a widespread condition that can significantly affect physical functioning, sleep, emotional well-being, and overall quality of life. Many individuals living with chronic pain seek non-pharmacologic strategies to support symptom management, particularly approaches that may improve sleep and relaxation. Weighted blankets are commercially available products designed to apply gentle, evenly distributed pressure across the body. Although these blankets are widely used to promote comfort and relaxation during sleep, limited research has examined their use among adults with chronic pain.
This study is a single-arm pilot trial designed to explore the feasibility and participant experiences associated with nightly use of a weighted blanket among adults with chronic pain. The study will examine whether regular use of a weighted blanket during sleep is associated with changes in self-reported pain, sleep, and quality of life over a short intervention period. In addition to quantitative survey measures, participant feedback will provide insight into acceptability, adherence, and perceived benefits or challenges related to using a weighted blanket for pain management.
Adults with chronic pain will be recruited to participate in the study. Following eligibility screening and informed consent, participants will complete baseline questionnaires during a virtual enrollment visit. These assessments will include the PEG scale to measure pain intensity and interference, and the PROMIS-29 profile to assess domains of physical function, sleep disturbance, fatigue, anxiety, depression, and pain interference, along with demographic and health-related information.
Participants will receive a weighted blanket sized to approximately 10 percent of their body weight and will be instructed to use the blanket nightly while sleeping. Blanket weight will be assigned based on participant body weight using the following categories: participants weighing 100-149.9 pounds will receive a 10-pound blanket; participants weighing 150-199.9 pounds will receive a 15-pound blanket; participants weighing 200-249.9 pounds will receive a 20-pound blanket; and participants weighing 250-299.9 pounds will receive a 25-pound blanket. Participants will begin with a 7-day adjustment period to become accustomed to the blanket, followed by a 4-week intervention period during which the weighted blanket will be used nightly during sleep.
The active study phase will last four weeks. During this time, participants will be asked to use the weighted blanket nightly while sleeping. Participants will complete brief weekly surveys to report their adherence to using the blanket and share information about their experiences during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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: Male and non-pregnant female adult participants must 18 years of age or older
- •Duration of pain: at least 3 months
- •Average Pain Intensity over the past week: ≥3/10 NRS
- •Safely able to lift a weighted blanket that is 10% of the participant's self-reported body weight (10-25 lbs.) without assistance.
- •Willing to sleep with a weighted blanket (10-25 lbs.) for a total of 35 (7 days for Run-In/Adjustment + 28 days of trial).
- •Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study.
- •Willing to undergo study procedures, including completion of online questionnaires and surveys, and attend virtual study visits.
- •Informed Consent: Participants must be able to provide informed consent and comply with the study procedure.
- •Able to speak, read, and understand English.
- •Able to access WIFI to attend virtual visits and complete study surveys.
排除标准
- •Age: Participants younger than 18 years old.
- •Currently using a weighted blanket (will have opportunity for washout period)
- •Inability to lift a 10-25 lbs. (10% of body weight) weighted blanket without assistance.
- •Inability or unwillingness to sleep with the weighted blanket nightly
- •Breathing/Respiratory Issue: Obstructive sleep apnea (OSA), Chronic obstructive Pulmonary Disease (COPD- includes emphysema and chronic bronchitis), Tuberculosis (TB), severe asthma
- •Cancer: Lung cancer
- •Cardiovascular Disease: Congestive heart failure (CHF), severe cardiomyopathy
- •Circulatory Issues: Severe peripheral artery disease (PAD), severe or uncontrolled Type 2 Diabetes
- •Recent surgery: Participants who recently had surgery and/or have an open wound.
- •Pregnancy or Lactation: Individuals who are pregnant, lactating, or planning a pregnancy within the next 35 days.
- •Co-sleeping: Individuals who co-sleep with their infant or young child.
- •Allergies: Known allergy or hypersensitivity to any component of the study products (including cotton material, natural and plant-based dyes).
- •Claustrophobia
- •Participation in Other Pain Trials: Currently participating in another pain research study.
- •Any condition that, in the opinion of the Investigator, does not justify the individuals' participation in the study that may impact their safety or confound trial results. This includes an increase in the participants' pain intensity during the baseline week or the active part of the trial.
研究组 & 干预措施
Weighted Blanket Nightly Use for Chronic Pain
Participants will receive a weighted blanket sized to approximately 10 percent of their body weight and will be instructed to use the blanket nightly during sleep. The study includes a 7-day run-in adjustment period followed by a 4-week intervention period. The run-in period allows participants to become accustomed to the blanket and assess tolerability. Participants who tolerate the blanket will continue using it nightly for the 4-week study phase. Participants will complete questionnaires at baseline, after the run-in period, and at the end of the study, along with brief weekly surveys to report adherence and experiences using the weighted blanket.
干预措施: Weighted Blanket (Device)
结局指标
主要结局
Change in self-reported pain intensity
时间窗: Baseline to end of intervention (approximately 5 weeks)
Change in participant-reported pain intensity and interference as measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a validated 3-item measure assessing average pain intensity, pain interference with enjoyment of life, and pain interference with general activity over the past week, each rated on a 0-10 numeric scale. A composite score is calculated as the mean of the three items, with higher scores indicating greater pain and interference. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes following nightly use of a weighted blanket.
次要结局
- Change in physical function(Baseline to end of intervention (approximately 5 weeks))
- Change in anxiety(Baseline to end of intervention (approximately 5 weeks))
- Change in depression(Baseline to end of intervention (approximately 5 weeks))
- Change in fatigue(Baseline to end of intervention (approximately 5 weeks))
- Change in sleep disturbance(Baseline to end of intervention (approximately 5 weeks))
- Change in ability to participate in social roles and activities(Baseline to end of intervention (approximately 5 weeks))
- Change in pain interference(Baseline to end of intervention (approximately 5 weeks))
- Change in cognitive function(Baseline to end of intervention (approximately 5 weeks))
- Change in pain intensity(Baseline to end of intervention (approximately 5 weeks))
研究者
Carina Staab
Principal Investigator
National University of Natural Medicine