Weighted Blankets for Postsurgical Pain

NCT ID: NCT05324254

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postsurgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Heavier blanket

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

Group Type EXPERIMENTAL

Weighted blanket

Intervention Type DEVICE

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

Lighter blanket

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

Group Type EXPERIMENTAL

Weighted blanket

Intervention Type DEVICE

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

Waitlist control

No blanket will be provided until the end of the study; participants will sleep with their normal bedding.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Weighted blanket

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Laura Case

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Actri, Ucsd

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laura K Case, PhD

Role: CONTACT

858-246-4968

Facility Contacts

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Laura Case

Role: primary

Other Identifiers

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210487

Identifier Type: -

Identifier Source: org_study_id

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