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Recruiting NCT06966466

Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients

No phase Interventional Deep Touch Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HuGgy Compression vest.
Who it may be relevant to
Registry conditions: Deep Touch Pressure. Basic parameters: 3 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Incidence of Emergence Agitation in Post-anesthesia care unit [Time frame: Within 30 minutes of recovery room admission.]
Secondary outcome measures (6)
  • Maximum PAED Scale Score in Post-Anesthesia Care Unit [Time frame: From PACU admission to discharge (up to 1 hour)]
  • Incidence of Severe Emergence Agitation (EA) in PACU [Time frame: From PACU admission to discharge (up to 1 hour)]
  • Maximum FLACC Pain Score in PACU [Time frame: From PACU admission to discharge (up to 1 hour)]
  • Duration of PACU Stay [Time frame: From PACU admission to discharge (up to 1 hour)]
  • Use of Rescue Medication in PACU [Time frame: From PACU admission to discharge (up to 1 hour)]
  • Compliance with Deep Touch Pressure (DTP) Intervention [Time frame: From PACU admission to discharge (up to 1 hour)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • Seoul National University Children's Hospital — Seoul

Identifiers

NCT: NCT06966466 · 2503-017-1620

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗