Weighted Blanket Use for Adults With Chronic Pain

Official title

A Single-Arm Pilot Study Investigating Weighted Blanket Use for Chronic Pain

Overview

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.

Detailed description

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.

At the conclusion of the study, participants will complete follow-up questionnaires consistent with baseline measures, including the PEG scale and PROMIS-29 profile. These assessments will be used to evaluate changes in pain, sleep, physical function, and quality-of-life domains over the study period. Participants will also complete open-ended survey questions to describe their experiences using the weighted blanket, including any perceived benefits, challenges, or changes in symptoms.

This pilot study is designed to provide preliminary data regarding the acceptability, adherence, and potential effects of weighted blanket use among adults with chronic pain. The findings will help inform the design of future research examining non-medication approaches for chronic pain management and may guide the development of larger controlled studies in this area.

Interventions

• Device Weighted Blanket
  Participants 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

Primary outcome measures

• Change in self-reported pain intensity [Time frame: Baseline to end of intervention (approximately 5 weeks)]

Secondary outcome measures (9)

• Change in physical function [Time frame: Baseline to end of intervention (approximately 5 weeks)]
• Change in anxiety [Time frame: Baseline to end of intervention (approximately 5 weeks)]
• Change in depression [Time frame: Baseline to end of intervention (approximately 5 weeks)]
• Change in fatigue [Time frame: Baseline to end of intervention (approximately 5 weeks)]
• Change in sleep disturbance [Time frame: Baseline to end of intervention (approximately 5 weeks)]
• Change in ability to participate in social roles and activities [Time frame: Baseline to end of intervention (approximately 5 weeks)]
• Change in pain interference [Time frame: Baseline to end of intervention (approximately 5 weeks)]
• Change in cognitive function [Time frame: Baseline to end of intervention (approximately 5 weeks)]
• Change in pain intensity [Time frame: Baseline to end of intervention (approximately 5 weeks)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• National University of Natural Medicine — Portland

Publications

• Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005- PMID 20685078
• Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009 Jun;24(6):733-8. doi: 10.1007/s11606-009-0981-1. Epub 2009 May 6. PMID 19418100
• Benbir Senel G, Karadeniz D. Interim Analysis of a Prospective Polysomnographic Study of Weighted Blankets in Patients with Psychophysiological Insomnia. Psychiatry Clin Psychopharmacol. 2024 Dec 17;34(4):365-370. doi: 10.5152/pcp.2024.23795. PMID 39772300
• Suri P, Heagerty PJ, Timmons A, Jensen MP. Description and initial validation of a novel measure of pain intensity: the Numeric Rating Scale of Underlying Pain without concurrent Analgesic use. Pain. 2024 Jul 1;165(7):1482-1492. doi: 10.1097/j.pain.0000000000003150. Epub 2024 Jan 2. PMID 38189184
• Baumgartner JN, Quintana D, Leija L, Schuster NM, Bruno KA, Castellanos JP, Case LK. Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. J Pain. 2022 Jan;23(1):156-174. doi: 10.1016/j.jpain.2021.07.009. Epub 2021 Aug 20. PMID 34425251
• Baumgartner JN, Haupt MR, Case LK. Chronic pain patients low in social connectedness report higher pain and need deeper pressure for pain relief. Emotion. 2023 Dec;23(8):2156-2168. doi: 10.1037/emo0001228. Epub 2023 Mar 30. PMID 36996174
• Yu J, Yang Z, Sun S, Sun K, Chen W, Zhang L, Xu J, Xu Q, Liu Z, Ke J, Zhang L, Zhu Y. The effect of weighted blankets on sleep and related disorders: a brief review. Front Psychiatry. 2024 Apr 15;15:1333015. doi: 10.3389/fpsyt.2024.1333015. eCollection 2024. PMID 38686123
• Ekholm B, Spulber S, Adler M. A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders. J Clin Sleep Med. 2020 Sep 15;16(9):1567-1577. doi: 10.5664/jcsm.8636. PMID 32536366

Identifiers

NCT: NCT07498491 · CS123025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗