Pain, PostsurgicalNCT05324254
Weighted Blankets for Postsurgical Pain
A study testing Weighted blanket in people with Pain, Postsurgical, run by University of California, San Diego at 1 site in United States.
Trial summary
The strongest psychological predictor of persistent pain after surgery is anxiety before surgery. The weight of blanket a person uses overnight may alter both anxiety and pain levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postsurgical
- 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
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2022to May 2027
- Phase
- Interventional
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
- Fluent in English
- Undergoing breast surgery
- Willing to sleep with a weighted blanket for up to 3 months
- BMI of at least 18.5 and able to safely lift up to 15lb
- Willing and able to use their personal smartphone for the ecological momentary assessment app to submit ratings using personal data plan
Who cannot join
- Pregnancy
- Chronic high-dose opioid use
- Current or previous use of a weighted blanket
- Claustrophobia
- Incarceration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Actri, Ucsd
La Jolla, California, 92093
Laura Case
About this study
Official title: Effect of Weighted Blankets on Perioperative Anxiety and Postsurgical Pain
The strongest psychological predictor of persistent pain after surgery is anxiety before surgery. The weight of blanket a person uses overnight may alter both anxiety and pain levels. The proposed study will determine whether a heavier or lighter blanket alters presurgical anxiety or postsurgical pain in individuals undergoing a breast surgery. We will also study whether any blanket-induced changes in postsurgical pain are related to reductions in anxiety before surgery induced by the blanket. Finally, we will examine clinical and psychological factors that might explain differences in how surgical patients respond to blanket weight. This research will improve our understanding of whether blanket weight can alter anxiety before a surgery or pain after a surgery.
- Conditions
- Pain, Postsurgical
- Being tested
- Weighted blanket
- Keywords
- mastectomy, anxiety, blankets
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
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 |
|---|---|---|
| Heavier blanket | Experimental | A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants. Receives: Device: Weighted blanket |
| Lighter blanket | Experimental | A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants. Receives: Device: Weighted blanket |
| Waitlist control | No intervention | No blanket will be provided until the end of the study; participants will sleep with their normal bedding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety ratings from before to during blanket use before surgery
Anxiety ratings will be compared before and during use of weighted blanket on the following scale: "Extremely anxious" to "Neutral" to "Extremely calm"
Measured: arrival to surgical center and final rating prior to surgery
Change in postsurgical pain from before to after overnight blanket use
Brief Pain Inventory score will be compared before and after overnight use of assigned blanket
Measured: baseline (before surgery) and 1 and 3 months after surgery
Change in medication use from before to after overnight blanket use
Medications taken in past 24 hours will be self-reported
Measured: baseline (before surgery) and 1 and 3 months after surgery
Secondary outcomes (2)
Change in postsurgical pain from before to after overnight blanket use
Pain ratings will be compared before and after overnight use of assigned blanket: Pain Intensity visual analog scale "No pain" to "Most intense pain imaginable" and Pain unpleasantness visual analog scale: "No unpleasantness" to "Most unpleasant pain imaginable"
Measured: baseline, 1 week, 1 month, and 3 months
Change in medication use from before to after overnight blanket use
Medications taken in past 24 hours will be self-reported
Measured: baseline, 1 week, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Oct 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostsurgicalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
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
- NCT05324254
- Sponsor's protocol ID
- 210487
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No