Acute Pain, Traumatic Injury
Conditions
Keywords
Weighted Blanket, Anxiety, Pain Management, Trauma
Brief summary
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.
Detailed description
This study is a prospective, single-center, randomized controlled trial evaluating weighted blanket use as a non-pharmacologic intervention for adult trauma inpatients admitted to Dell Seton Medical Center. Eligible participants who provide written informed consent will be randomized in a 1:1 ratio to receive either a commercially available weighted blanket or the standard hospital blanket routinely provided during hospitalization. Participants in both groups will otherwise receive routine clinical care. Assigned blankets will be provided according to randomized group assignment, and participants may use or discontinue use of their assigned blanket at their discretion. Study data will be collected through review of the electronic medical record and participant-reported assessments. Pain outcomes will be evaluated using Numeric Pain Rating Scale (NPRS) scores documented as part of routine clinical care. Anxiety will be assessed using a daily Visual Analog Scale (VAS) during the first seven study days following enrollment or until hospital discharge, whichever occurs first. Additional study measures include opioid utilization, vital signs, length of hospital stay, and participant-reported blanket use and satisfaction. Approximately 50 participants are expected to be enrolled. Study data will be analyzed to compare outcomes between the study groups and evaluate weighted blanket use as a non-pharmacologic adjunct to pain and anxiety management in adult trauma inpatients.
Interventions
DEVICEWeighted Blanket
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.
DEVICEStandard Hospital Blanket
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.
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either a commercially available weighted blanket or the standard hospital blanket routinely provided during hospitalization. Assigned blankets will be provided according to randomized group assignment, and participants may use or discontinue use of the assigned blanket at their discretion.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Medically stable for participation, as documented in the electronic medical record and/or confirmed by the treating clinical team
Exclusion criteria
* Age younger than 18 years * Age older than 89 years * Pregnant patients * Intubated or mechanically ventilated patients * Patients with burn injuries * Prisoners or incarcerated individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Daily Systolic Blood Pressure | Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first | 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). |
| Anxiety | 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. | 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). |
| Opioid Utilization | Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first | 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. |
| Average Daily Diastolic Blood Pressure | Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first | Diastolic blood pressure measurements documented in the electronic medical record as part of standard clinical care will be collected. For each participant, all available diastolic blood pressure measurements within each 24-hour study period following enrollment/randomization will be averaged to calculate one average daily diastolic blood pressure value, reported in millimeters of mercury (mmHg). |
| Average Daily Heart Rate | Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first | Heart rate measurements documented in the electronic medical record as part of standard clinical care will be collected. For each participant, all available heart rate measurements within each 24-hour study period following enrollment/randomization will be averaged to calculate one average daily heart rate value, reported in beats per minute (beats/min). |
| Average Daily Temperature | Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first | Temperature measurements documented in the electronic medical record as part of standard clinical care will be collected. Temperature values documented in degrees Celsius will be converted to degrees Fahrenheit prior to analysis. For each participant, all available temperature measurements within each 24-hour study period following enrollment/randomization will be averaged to calculate one average daily temperature value, reported in degrees Fahrenheit (°F). |
| Average Daily Respiratory Rate | Each 24-hour study period from enrollment/randomization through hospital discharge or 7 days whichever comes first | Respiratory rate measurements documented in the electronic medical record as part of standard clinical care will be collected. For each participant, all available respiratory rate measurements within each 24-hour study period following enrollment/randomization will be averaged to calculate one average daily respiratory rate value, reported in breaths per minute (breaths/min). |
| Blanket Use Frequency | Once, on the day of hospital discharge or within 24 hours prior to discharge. | Participants will report how often they used the blanket during the hospital stay using a 5-category ordinal response scale: Never, Rarely, Sometimes, Often, or Always. Responses will be summarized by category. |
| Typical Duration of Blanket Use | Once, on the day of hospital discharge or within 24 hours prior to discharge. | Participants will report the typical duration of blanket use on days when the blanket was used. Response categories are: Not applicable - did not use the blanket; Less than 30 minutes; 30 minutes to 1 hour; 1 to 2 hours; More than 2 hours but not overnight; or Overnight/throughout the day. Responses will be summarized by category. |
| Reasons for Not Using the Blanket | Once, on the day of hospital discharge or within 24 hours prior to discharge. | Participants who chose not to use the blanket at any point will be asked to select one or more reasons. Response options consist of: blanket was too heavy, too warm, uncomfortable on the injury, participant did not feel it was needed, participant forgot it was available, or other (please list the reason). The number and percentage of participants selecting each reason will be reported. |
| Overall Blanket Satisfaction | Once, on the day of hospital discharge or within 24 hours prior to discharge. | Participants will rate their overall satisfaction with the blanket using a 5-point ordinal satisfaction scale ranging from Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied. Responses will be coded from 1 to 5, with higher scores indicating greater satisfaction and therefore a better outcome. |
| Length of Hospital Stay | From hospital admission through hospital discharge; assessed once at discharge. | 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. |
| Preference for Future Blanket Availability | Once, on the day of hospital discharge or within 24 hours prior to discharge. | Participants will indicate whether they would want a blanket available during a future hospital stay using a 5-point ordinal response scale: Definitely not, Probably not, Unsure, Probably yes, or Definitely yes. Responses will be coded from 1 to 5, with higher scores indicating a greater preference for future blanket availability. |
Countries
United States
Contacts
CONTACTCarlos Brown, MD
CONTACTSadia Ali, MPH
PRINCIPAL_INVESTIGATORCarlos Brown, MD
The University of Texas at Austin
Outcome results
None listed