Weighted Blankets for Postsurgical Pain

Conditions

• Pain, Postsurgical

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Oct 1, 2022

Status verified

Apr 2026

Primary completion

May 31, 2027

Completion

May 31, 2027

Study Design

Enrollment

168 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Heavier blanket
  A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
• Experimental: Lighter blanket
  A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.
• No Intervention: Waitlist control
  No blanket will be provided until the end of the study; participants will sleep with their normal bedding.

Primary Outcome Measure

Change in anxiety ratings from before to during blanket use before surgery [ Time Frame: arrival to surgical center and final rating prior to surgery ]

Central Contacts

• Laura K Case, PhD
  858-246-4968
  [email protected]

Locations (1)

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