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NCT Number: NCT05324254

Weighted Blankets for 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.

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Key information

Conditions

Pain, Postsurgical Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Actri, Ucsd

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Laura Case

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Weighted blanket

Device

A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.

Primary outcomes

  1. Change in anxiety ratings from before to during blanket use before surgery

    Time frame: 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"

  2. Change in postsurgical pain from before to after overnight blanket use

    Time frame: 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

  3. Change in medication use from before to after overnight blanket use

    Time frame: baseline (before surgery) and 1 and 3 months after surgery

    Medications taken in past 24 hours will be self-reported

Secondary outcomes

  1. Change in postsurgical pain from before to after overnight blanket use

    Time frame: 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"

  2. Change in medication use from before to after overnight blanket use

    Time frame: baseline, 1 week, 1 month, and 3 months

    Medications taken in past 24 hours will be self-reported

Study contacts

Contact information is provided by the study sponsor or research team.

Laura K Case, PhD

CONTACT

[email protected]

858-246-4968

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Effect of Weighted Blankets on Perioperative Anxiety and Postsurgical Pain

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 12, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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