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Weighted Blankets for Postsurgical Pain

Primary Purpose

Pain, Postsurgical

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weighted blanket
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postsurgical focused on measuring mastectomy, anxiety, blankets

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Actri, UcsdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Heavier blanket

Lighter blanket

Waitlist control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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"
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
Change in medication use from before to after overnight blanket use
Medications taken in past 24 hours will be self-reported

Secondary Outcome Measures

Change in postsurgical pain from before to after overnight blanket use
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
Medications taken in past 24 hours will be self-reported

Full Information

First Posted
April 4, 2022
Last Updated
November 2, 2022
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05324254
Brief Title
Weighted Blankets for Postsurgical Pain
Official Title
Effect of Weighted Blankets on Perioperative Anxiety and Postsurgical Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postsurgical
Keywords
mastectomy, anxiety, blankets

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heavier blanket
Arm Type
Experimental
Arm Description
A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Arm Title
Lighter blanket
Arm Type
Experimental
Arm Description
A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
Arm Title
Waitlist control
Arm Type
No Intervention
Arm Description
No blanket will be provided until the end of the study; participants will sleep with their normal bedding.
Intervention Type
Device
Intervention Name(s)
Weighted blanket
Intervention Description
A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
Primary Outcome Measure Information:
Title
Change in anxiety ratings from before to during blanket use before surgery
Description
Anxiety ratings will be compared before and during use of weighted blanket on the following scale: "Extremely anxious" to "Neutral" to "Extremely calm"
Time Frame
arrival to surgical center and final rating prior to surgery
Title
Change in postsurgical pain from before to after overnight blanket use
Description
Brief Pain Inventory score will be compared before and after overnight use of assigned blanket
Time Frame
baseline (before surgery) and 1 and 3 months after surgery
Title
Change in medication use from before to after overnight blanket use
Description
Medications taken in past 24 hours will be self-reported
Time Frame
baseline (before surgery) and 1 and 3 months after surgery
Secondary Outcome Measure Information:
Title
Change in postsurgical pain from before to after overnight blanket use
Description
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"
Time Frame
baseline, 1 week, 1 month, and 3 months
Title
Change in medication use from before to after overnight blanket use
Description
Medications taken in past 24 hours will be self-reported
Time Frame
baseline, 1 week, 1 month, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura K Case, PhD
Phone
858-246-4968
Email
lcase@health.ucsd.edu
Facility Information:
Facility Name
Actri, Ucsd
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Case

12. IPD Sharing Statement

Plan to Share IPD
No

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Weighted Blankets for Postsurgical Pain

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