Health TrialsbyHealthPanel

Weighted Blankets for Pain and Anxiety in Adult Trauma Patients

ConditionsTraumatic InjuryAcute Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Texas at Austin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 89 years

Patients admitted to the trauma service at Dell Seton Medical Center

Glasgow Coma Scale (GCS) score of 15 at the time of enrollment

Able to provide informed consent and participate in study assessments

Disqualifiers

Age younger than 18 years

Age older than 89 years

Pregnant patients

Intubated or mechanically ventilated patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Weighted BlanketExperimental treatment 1 intervention
Group B: Standard Hospital BlanketActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity

Pain intensity will be assessed using routinely documented Numeric Pain Rating Scale (NPRS) scores collected from the electronic medical record as part of standard clinical care, typically every 6 to 8 hours. The NPRS ranges from 0 to 10, with higher scores indicating greater pain intensity. For each participant, all available NPRS scores within each 24-hour study period following enrollment/randomization will be averaged to calculate one average daily pain score.

Time frame
Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first

Secondary outcomes

1

Anxiety

Anxiety will be assessed daily using the Anxiety Visual Analog Scale (VAS), a 100-millimeter horizontal line anchored by "Not at all anxious" (0 mm) on the left and "Extremely anxious" (100 mm) on the right. Scores range from 0 to 100 mm, with higher scores indicating greater anxiety (a worse outcome).

Time frame
Everyday for up to the first 7 study days following enrollment/randomization, or until hospital discharge, participant withdrawal, or loss of capacity to continue participation, whichever occurs first.
2

Opioid Utilization

Opioid utilization will be calculated as daily morphine milligram equivalents (MME) using opioid medications documented in the electronic medical record. For each participant, daily MME will be calculated for each available 24-hour study period following enrollment/randomization.

Time frame
Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first
3

Length of Hospital Stay

Total inpatient hospital length of stay will be calculated from the date of hospital admission through the date of hospital discharge using data obtained from the electronic medical record and reported in days.

Time frame
From hospital admission through hospital discharge; assessed once at discharge.
4

Average Daily Systolic Blood Pressure

Systolic blood pressure measurements documented in the electronic medical record as part of standard clinical care will be collected. For each participant, all available systolic blood pressure measurements within each 24-hour study period following enrollment/randomization will be averaged to calculate one average daily systolic blood pressure value, reported in millimeters of mercury (mmHg).

Time frame
Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: