Pain, Postsurgical
Conditions
Keywords
mastectomy, anxiety, blankets
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.
Interventions
DEVICEWeighted blanket
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Partial masking: Although blanket heaviness will be perceived, blanket weights tested in the study will not be disclosed to participants. Wait-list control group will know they are not receiving active intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety ratings from before to during blanket use before surgery | arrival to surgical center and final rating prior to surgery | Anxiety ratings will be compared before and during use of weighted blanket on the following scale: "Extremely anxious" to "Neutral" to "Extremely calm" |
| Change in postsurgical pain from before to after overnight blanket use | baseline (before surgery) and 1 and 3 months after surgery | Brief Pain Inventory score will be compared before and after overnight use of assigned blanket |
| Change in medication use from before to after overnight blanket use | baseline (before surgery) and 1 and 3 months after surgery | Medications taken in past 24 hours will be self-reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in postsurgical pain from before to after overnight blanket use | baseline, 1 week, 1 month, and 3 months | 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" |
| Change in medication use from before to after overnight blanket use | baseline, 1 week, 1 month, and 3 months | Medications taken in past 24 hours will be self-reported |
Countries
United States
Contacts
CONTACTLaura K Case, PhD
Outcome results
None listed