NCT05324254 Weighted Blankets for Postsurgical Pain
| NCT ID | NCT05324254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Pain, Postsurgical |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2022-10-01 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy * Chronic high-dose opioid use * Current or previous use of a weighted blanket * Claustrophobia * Incarceration
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05324254 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain, Postsurgical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05324254 currently recruiting?
Yes, NCT05324254 is actively recruiting participants. Contact the research team at lcase@health.ucsd.edu for enrollment information.
Where is the NCT05324254 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT05324254 clinical trial?
NCT05324254 is sponsored by University of California, San Diego. The trial plans to enroll 168 participants.