Chronic PainNCT04447885
Weighted Blankets and Chronic Pain
A study testing weighted blanket in people with Chronic Pain and Chronic Pain Syndrome, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Chronic Pain Syndrome
- What is being tested?
- weighted blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2020to 25 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Fluent in English
- Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org)
- Willing to sleep with a weighted blanket and fitness watch for 1 week
- Able to safely lift up to 15lb
- Willing and able to use their personal smartphone for fitness tracker app and EMA app to submit ratings using personal data plan
Who cannot join
- Pregnancy
- Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder)
- Current or previous use of a weighted blanket
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested.
- Conditions
- Chronic Pain, Chronic Pain Syndrome
- Being tested
- weighted blanket
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weighted blanketDevice
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
| Study group | Role | What they receive |
|---|---|---|
| Experimental blanket | Experimental | This blanket is the weight being tested which cannot be disclosed without unblinding participants. Receives: Device: weighted blanket |
| Control blanket | Active comparator | This blanket is the control weight which cannot be disclosed without unblinding participants. Receives: Device: weighted blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain ratings from before to after brief blanket use
Pain ratings will be compared before and after use of weighted blanket on the following scale: Pain VAS: "No pain" to "Worst pain ever" (higher = worse).
Measured: 0 and 15 minutes
Change in pain ratings from before to after nightly blanket use
Pain ratings will be compared before and after 1 week of nightly use of weighted blanket on the following scale: Pain VAS: "No pain" to "Worst pain ever" (higher = worse).
Measured: at baseline (3 nights) and over 7 nights of use
Secondary outcomes (3)
Change in anxiety ratings from before to after brief blanket use
Anxiety ratings will be compared before and after use of weighted blanket on the following scale: Anxiety VAS: "Extremely anxious" to "Neutral" to "Extremely calm" (higher = better).
Measured: 0 and 15 minutes; also at baseline (3 nights) and over 7 nights of use
Change in ratings of sleep quality from before to after brief blanket use
Change in sleep quality from before to after use of weighted blanket will be compared on the following scale: perceived sleep quality VAS: "Extremely poor" to "Neutral" to "Extremely good" (higher = better).
Measured: baseline (3 nights) and over 7 nights of use
Change in sleep quality measured by fitness watch from before to during week of blanket use
Change in sleep quality from before to during use of weighted blanket will be compared by measurement of deep vs light sleep from a fitness watch.
Measured: baseline (3 nights) and over 7 nights of use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start4 Jun 2020
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Case, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447885
- Sponsor's protocol ID
- 200628
- Status last verified
- Apr 2021
- First submitted
- 18 Jun 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34425251
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weighted Blankets and Chronic Pain
- ClinicalTrials.gov ID
- NCT04447885
- Acronym / sponsor ID
- 200628
- Conditions
- Chronic Pain, Chronic Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental blanket | Experimental | Device: weighted blanketThis blanket is the weight being tested which cannot be disclosed without unblinding participants. |
| Control blanket | Active comparator | Device: weighted blanketThis blanket is the control weight which cannot be disclosed without unblinding participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Fluent in English
- Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org)
- Willing to sleep with a weighted blanket and fitness watch for 1 week
- Able to safely lift up to 15lb
Key exclusion criteria (4 listed)
- Pregnancy
- Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder)
- Current or previous use of a weighted blanket
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weighted blanketA weighted blanket is a blanket with extra weight sewn in for added pressure to the body. | Device | Control blanket, Experimental blanket |
Primary outcome
Change in pain ratings from before to after brief blanket use
Time frame: 0 and 15 minutes
Pain ratings will be compared before and after use of weighted blanket on the following scale: Pain VAS: "No pain" to "Worst pain ever" (higher = worse).
Change in pain ratings from before to after nightly blanket use
Time frame: at baseline (3 nights) and over 7 nights of use
Pain ratings will be compared before and after 1 week of nightly use of weighted blanket on the following scale: Pain VAS: "No pain" to "Worst pain ever" (higher = worse).
3 secondary outcomes
Change in anxiety ratings from before to after brief blanket use
Time frame: 0 and 15 minutes; also at baseline (3 nights) and over 7 nights of use
Change in ratings of sleep quality from before to after brief blanket use
Time frame: baseline (3 nights) and over 7 nights of use
Change in sleep quality measured by fitness watch from before to during week of blanket use
Time frame: baseline (3 nights) and over 7 nights of use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 34425251Baumgartner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weighted blanket in people with Chronic Pain and Chronic Pain Syndrome, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain ratings from before to after brief blanket use (time frame: 0 and 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04447885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.