Weighted Blanket Use for Adults With Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational University of Natural Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Weighted Blanket
DeviceParticipants will receive a weighted blanket sized to approximately 10 percent of their body weight for nightly use during sleep. Blanket weight will be assigned by body weight: 10 lb (100-149.9 lbs), 15 lb (150-199.9 lbs), 20 lb (200-249.9 lbs), and 25 lb (250-299.9 lbs). The blanket provides evenly distributed deep pressure across the body through weighted filling materials sewn into the fabric. Participants will begin with a 7-day run-in adjustment period to become accustomed to sleeping with the blanket and to assess tolerability. Those who tolerate the blanket will continue nightly use during a 4-week intervention period. The weighted blanket is intended to provide gentle pressure stimulation during sleep and is being evaluated as a non-pharmacologic approach that may support relaxation, sleep quality, and overall comfort in adults living with chronic pain.
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Weighted Blanket Nightly Use for Chronic PainExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in self-reported pain intensity
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.
Time frame
Baseline to end of intervention (approximately 5 weeks)Secondary outcomes
1
Change in physical function
Change in physical function as measured by the PROMIS-29 Physical Function subdomain. This subdomain includes four self-reported items assessing the ability to perform daily activities. Each item is rated on a 5-point scale from 5 (without any difficulty) to 1 (unable to do), with higher scores indicating better physical function. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating better physical function. T-scores may be interpreted as within normal limits (\>45), mild (40-44), moderate (30-39), or severe (\<30) impairment. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in physical function following nightly use of a weighted blanket.
Time frame
Baseline to end of intervention (approximately 5 weeks)2
Change in anxiety
Change in anxiety as measured by the PROMIS-29 Anxiety subdomain. This subdomain includes four self-reported items assessing feelings of fear, difficulty focusing due to anxiety, feeling overwhelmed by worry, and general unease over the past 7 days. Each item is rated on a 5-point scale from 1 (never) to 5 (always), with higher scores indicating greater anxiety severity. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating greater anxiety. T-scores may be interpreted as within normal limits (\<55), mild (55-59), moderate (60-69), or severe (≥70) anxiety. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in anxiety following nightly use of a weighted blanket.
Time frame
Baseline to end of intervention (approximately 5 weeks)3
Change in depression
Change in depression as measured by the PROMIS-29 Depression subdomain. This subdomain includes four self-reported items assessing feelings of worthlessness, helplessness, depression, and hopelessness over the past 7 days. Each item is rated on a 5-point scale from 1 (never) to 5 (always), with higher scores indicating greater depressive symptoms. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating greater depression severity. T-scores may be interpreted as within normal limits (\<55), mild (55-59), moderate (60-69), or severe (≥70) depression. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in depressive symptoms following nightly use of a weighted blanket.
Time frame
Baseline to end of intervention (approximately 5 weeks)4
Change in fatigue
Change in fatigue as measured by the PROMIS-29 Fatigue subdomain. This subdomain includes four self-reported items assessing feelings of fatigue, difficulty initiating activities due to tiredness, feelings of being run-down, and average fatigue over the past 7 days. Each item is rated on a 5-point scale from 1 (not at all) to 5 (very much), with higher scores indicating greater fatigue severity. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating greater fatigue. T-scores may be interpreted as within normal limits (\<55), mild (55-59), moderate (60-69), or severe (≥70) fatigue. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in fatigue following nightly use of a weighted blanket.
Time frame
Baseline to end of intervention (approximately 5 weeks)Other outcomes
1
Participant adherence to weighted blanket use
Participants will complete brief weekly surveys reporting how consistently they used the weighted blanket during sleep. Responses will be used to assess adherence to the nightly intervention.
Time frame
Weekly during the 4-week intervention period2
Participant experience with weighted blanket use
Participants will complete open-ended survey questions describing their experiences using the weighted blanket, including perceived benefits, challenges, and overall acceptability of the intervention.
Time frame
End of study (approximately 5 weeks)Sponsors and contacts
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Source ClinicalTrials.gov