NCT05324254

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Oct 2022May 2027

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

April 4, 2022

Last Update Submit

April 27, 2026

Conditions

Pain, Postsurgical

Keywords

mastectomyanxietyblankets

Outcome Measures

Primary Outcomes (3)

  • 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"

    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

    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

    baseline (before surgery) and 1 and 3 months after surgery

Secondary Outcomes (2)

  • Change in postsurgical pain from before to after overnight blanket use

    baseline, 1 week, 1 month, and 3 months

  • Change in medication use from before to after overnight blanket use

    baseline, 1 week, 1 month, and 3 months

Study Arms (3)

Heavier blanket

EXPERIMENTAL

A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

Device: Weighted blanket

Lighter blanket

EXPERIMENTAL

A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

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.

Interventions

Weighted blanketDEVICE

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

Heavier blanketLighter blanket

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Chronic high-dose opioid use
  • Current or previous use of a weighted blanket
  • Claustrophobia
  • Incarceration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Actri, Ucsd

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeAnxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental Disorders

Central Study Contacts

Laura K Case, PhD

CONTACT

858-246-4968lcase@health.ucsd.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

October 1, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)