ACTIVE_NOT_RECRUITING

Vital Signs Reduction Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Minimizing Overnight Vital Signs to Improve Sleep in Hospitalized Children

Quick Facts

Study Start:2024-07-17
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06865781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Hospitalized at Primary Children's Hospital on units 3 Southeast, 3 Northeast, 3 Northwest
  2. * Age 1-18 years
  3. * Pediatric Early Warning Score ≤ 1 at 2000
  4. * A parent/home caregiver present to consent to study
  5. * Patient and home caregiver speak English or Spanish.
  6. * Deemed appropriate for forgone overnight vital signs by care team (attending MD/Advanced Practice Provider and bedside RN).
  1. * Pre-existing diagnosis of hypertension, kidney disease, pulmonary hypertension, chronic lung disease, congenital heart disease causing cardiopulmonary compromise, obstructive sleep apnea, seizure disorder, neuromuscular disability.
  2. * Patients requiring O2 monitoring at home.
  3. * The following medications in the previous 24 hours: opioids, intravenous immunoglobulin, intravenous magnesium, continuous albuterol, benzodiazepines, other sedating medications beyond home regimen.
  4. * Anaphylaxis within 24 hours
  5. * Within the first 24 hours post-operative period
  6. * Requiring oxygen above baseline
  7. * Fever in the last 24 hours.
  8. * Sepsis alert in the last 72 hours.

Contacts and Locations

Principal Investigator

Leandra Bitterfeld, MSN
PRINCIPAL_INVESTIGATOR
Intermountain Primary Children's Hospital

Study Locations (Sites)

Intermountain Primary Children's Hospital
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Intermountain Health Care, Inc.

  • Leandra Bitterfeld, MSN, PRINCIPAL_INVESTIGATOR, Intermountain Primary Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-17
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2024-07-17
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • pediatric
  • hospitalization
  • vital signs
  • sleep

Additional Relevant MeSH Terms

  • Hospitalization