Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients
NCT ID: NCT06966466
Last Updated: 2025-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
94 participants
INTERVENTIONAL
2025-05-12
2028-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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DTP group
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.
Control group
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
3 Years
10 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Ji-Hyun Lee
Professor
Locations
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Seoul National University Children's Hospital
Seoul, Seoul, South Korea
Countries
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Facility Contacts
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Other Identifiers
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2503-017-1620
Identifier Type: -
Identifier Source: org_study_id
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