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Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients

Study acronym: HUGGY
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary completion date changed from estimate of Mar 1, 2028 to Jul 13, 2026 · Eligibility criteria expanded, about 7 words · Site details revised Show 3 more changesShow less
    • Primary completion date changed from estimate of Mar 1, 2028 to Jul 13, 2026
    • Eligibility criteria expanded, about 7 words
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of May 12, 2025 to Sep 4, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of May 12, 2025 to Sep 4, 2025
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to determine if deep touch pressure (DTP) can reduce emergence agitation (EA) in pediatric patients aged 3 to 10 years undergoing tonsillectomy and adenoidectomy under general anesthesia. The main questions it aims to answer are: Does deep touch pressure (DTP) using a compression vest reduce the incidence of emergence agitation (EA) in the recovery room? Does DTP reduce the severity of EA, as measured by the Pediatric Assessment of Emergence Delirium (PAED) scale? Researchers will compare: Intervention Group: Pediatric patients who receive DTP using the HUGgy compression vest during the recovery period. Control Group: Pediatric patients who receive standard postoperative care without DTP. Participants will: Be randomly assigned to either the intervention group (DTP) or the control group. Undergo standard general anesthesia for tonsillectomy and adenoidectomy. Wear the HUGgy compression vest if assigned to the intervention group. Be monitored for emergence agitation using the PAED scale and FLACC pain scale in the recovery room. Receive rescue medication (nalbuphine) if severe EA occurs. This study will help determine if DTP can be used as a safe and effective non-pharmacological method to reduce emergence agitation in pediatric patients.
Trial Details
NCT Number NCT06966466
Lead Sponsor Seoul National University Hospital
Conditions Deep Touch Pressure
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov