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Overnight vital signs are typically done every four hours on pediatric acute care units, despite limited evidence supporting the efficacy of this practice. Additionally, vital signs are often ordered and collected without considering the patient's clinical status or the potential impact that they may have on sleep. The purpose of this study is to understand the effect of forgone overnight vital signs on sleep quality and duration among children hospitalized in medical-surgical units, compared with children who receive standard of care vital signs.
Patients will be screened at Primary Children's Hospital. Patients who are deemed eligible to forgo overnight vital signs will be considered for study. After written informed consent (parental permission/assent) is obtained, subjects who meet eligibility criteria will be allocated 1:1 to 2 treatment arms in sequential order: Group 1: standard of care vital signs monitoring and Group 2: no overnight vital signs at 0000 and 0400. The study period is approximately 24 hours, including one night of sleep. All participants will wear an actigraphy watch for one night and complete a sleep diary and sleep disruption survey after the study night. The primary endpoint is total sleep time, as measured by actigraphy. Secondary endpoints include nocturnal wake frequency, nocturnal wake duration (actigraphy), self-reported total sleep time (sleep diary), self-reported overnight disruptions (sleep diary), self-reported restfulness upon waking (sleep diary), self-reported sleep disturbances (sleep disturbance survey).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Receive standard of care vital signs | |
| Intervention group | Experimental | Will not receive vital signs at 0000 or 0400 of study night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forgone overnight vital signs | Other | No vital signs (temp, heart rate, respiratory rate, blood pressure, oxygen saturation) taken at 0000 or 0400 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time | Measured by actigraphy | From enrollment to end of treatment at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal wake frequency | By actigraphy | From enrollment to the end of treatment at 24 hours |
| Nocturnal wake duration | By actigraphy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leandra Bitterfeld, MSN | Intermountain Primary Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Primary Children's Hospital | Salt Lake City | Utah | 84112 | United States |
Individual patient data will not be shared because participant consent does not include data sharing outside of the study team.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2025 | Mar 4, 2025 | Prot_SAP_000.pdf |
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| From enrollment to the end of treatment at 24 hours |
| Total sleep time | By self report via sleep diary | From enrollment to the end of treatment at 24 hours |
| Overnight disruptions | By self report via sleep diary | From enrollment to the end of treatment at 24 hours |
| Restfulness upon waking | By self report via sleep diary | From enrollment to the end of treatment at 24 hours |
| Sleep disturbances | By self report via Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey | From enrollment to the end of treatment at 24 hours |