RecruitingNot Applicable

Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients

South Korea94 participantsStarted 2025-09-04

Plain-language summary

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.

Who can participate

Age range

3 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Emergence Agitation in Post-anesthesia care unit

Timeframe: Within 30 minutes of recovery room admission.

Trial details

NCT IDNCT06966466

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-01

View on ClinicalTrials.gov More Deep Touch Pressure trials