Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients (HUGGY)

Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Deep Touch Pressure
• Intervention / Treatment: Device: HuGgy Compression vest

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea
      • Recruiting
      • Seoul National University Children's Hospital
      • Contact: Park; Phone Number: 82-2-2072-3664; Email: jb4001@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients aged 3 to 10 years scheduled for tonsillectomy and adenoidectomy under general anesthesia.

Exclusion Criteria:

• Emergency surgery.
• Known neurological disorders (e.g., epilepsy, cerebral palsy).
• Skin disorders or injuries on the chest or upper body that prevent safe use of the compression vest (HUGgy).
• History of severe psychiatric disorders (e.g., autism spectrum disorder, severe anxiety disorder).
• History of severe allergic reactions to anesthesia.
• Any condition that, in the investigator's judgment, makes the patient unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: DTP group	Device: HuGgy Compression vest; This intervention involves the use of a HUGgy compression vest, a wearable device that provides deep touch pressure (DTP) to pediatric patients undergoing tonsillectomy and adenoidectomy under general anesthesia. The vest is worn by patients immediately after surgery, and pressure is applied to provide calming sensory input. The pressure level is adjusted based on the manufacturer's guidelines, providing a gentle, even compression to reduce emergence agitation (EA) during the recovery period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Emergence Agitation in Post-anesthesia care unit	The incidence of emergence agitation (EA) is defined as a PAED (Pediatric Assessment of Emergence Delirium) scale score greater than 10 within the first 30 minutes after admission to the post-anesthesia care unit	Within 30 minutes of recovery room admission.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum PAED Scale Score in Post-Anesthesia Care Unit	From PACU admission to discharge (up to 1 hour).	From PACU admission to discharge (up to 1 hour)
Incidence of Severe Emergence Agitation (EA) in PACU		From PACU admission to discharge (up to 1 hour)
Maximum FLACC Pain Score in PACU		From PACU admission to discharge (up to 1 hour)
Duration of PACU Stay		From PACU admission to discharge (up to 1 hour)
Use of Rescue Medication in PACU		From PACU admission to discharge (up to 1 hour)
Compliance with Deep Touch Pressure (DTP) Intervention		From PACU admission to discharge (up to 1 hour)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: May 9, 2025
• First Submitted That Met QC Criteria: May 9, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: 2503-017-1620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No