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

Seoul National University

Status

Not yet enrolling

Conditions

Deep Touch Pressure

Treatments

Device: HuGgy Compression vest

Study type

Interventional

Funder types

Other

Identifiers

NCT06966466

2503-017-1620

Details and patient eligibility

About

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.

Enrollment

94 estimated patients

Sex

All

Ages

3 to 10 years old

Volunteers

No Healthy Volunteers

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.