Weighted Blankets for Pain and Anxiety in Adult Trauma Patients

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT07802171
Status
Not Yet Recruiting

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Conditions

  • Acute Pain
  • Traumatic Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Weighted Blanket — DEVICE
    A commercially available weighted blanket provided by the study for use during hospitalization as a non-pharmacologic adjunct to routine trauma care. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time.
  • Standard Hospital Blanket — DEVICE
    The standard hospital blanket routinely provided during hospitalization and used as the comparator to the weighted blanket. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time.

Study Details

The purpose of this study is to determine whether the use of a weighted blanket improves pain and anxiety among adult trauma inpatients. Participants will be randomly assigned to receive either a weighted blanket or the standard hospital blanket routinely provided during hospitalization. Pain scores documented as part of routine clinical care and participant-reported anxiety ratings will be compared between groups. This study will evaluate whether weighted blankets may serve as a non-pharmacologic adjunct to pain and anxiety management for adult trauma inpatients.

Key Dates

First listed
Sep 3, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Weighted Blanket
    Participants randomized to this arm will receive a commercially available weighted blanket during hospitalization. Participants will otherwise receive routine trauma care. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time. The weighted blanket is considered investigational for this study purpose and is being evaluated for its effect on pain and anxiety in trauma inpatients.
  • Active Comparator: Standard Hospital Blanket
    Participants randomized to this arm will receive the standard hospital blanket routinely provided during hospitalization. Participants will otherwise receive routine trauma care. Participants will be encouraged to use the blanket while in bed or seated in a chair and may discontinue use at any time. Blankets are laundered and reused according to routine hospital practice.

Primary Outcome Measure

Pain Intensity [ Time Frame: Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dell Seton Medical Center at The University of TexasAustinTexas78701
Carlos Brown, MD
[email protected]
5123247776
Sadia Ali, MPH
[email protected]
5123247000
Carlos Brown, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Austin, TX

By research site
Dell Seton Medical Center at The University of Texas· Austin, TX

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