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NCT Number: NCT06966466

Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients

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.

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Key information

Conditions

Deep Touch Pressure

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HuGgy Compression vest

Device

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 outcomes

  1. Incidence of Emergence Agitation in Post-anesthesia care unit

    Time frame: Within 30 minutes of recovery room admission.

    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

Secondary outcomes

  1. Maximum PAED Scale Score in Post-Anesthesia Care Unit

    Time frame: From PACU admission to discharge (up to 1 hour)

    From PACU admission to discharge (up to 1 hour).

  2. Incidence of Severe Emergence Agitation (EA) in PACU

    Time frame: From PACU admission to discharge (up to 1 hour)

  3. Maximum FLACC Pain Score in PACU

    Time frame: From PACU admission to discharge (up to 1 hour)

  4. Duration of PACU Stay

    Time frame: From PACU admission to discharge (up to 1 hour)

  5. Use of Rescue Medication in PACU

    Time frame: From PACU admission to discharge (up to 1 hour)

  6. Compliance with Deep Touch Pressure (DTP) Intervention

    Time frame: From PACU admission to discharge (up to 1 hour)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: HUGGY

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 11, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.