Deep Touch PressureHUGGYNCT06966466
Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients
A study testing HuGgy Compression vest in people with Deep Touch Pressure, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Deep Touch Pressure
- What is being tested?
- HuGgy Compression vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Sep 2025to 13 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 3 to 10 years scheduled for tonsillectomy and adenoidectomy under general anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, Seoul
About this study
Official title: Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Prospective Randomized Controlled Study
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?
Read more
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.
- Conditions
- Deep Touch Pressure
- Being tested
- HuGgy Compression vest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuGgy Compression vestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DTP group | Experimental | Not described Receives: Device: HuGgy Compression vest |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Emergence Agitation in Post-anesthesia care unit
The incidence of emergence agitation (EA) is defined as a PAED (Pediatric Assessment of Emergence Delirium) scale score 10 or greater within the first 30 minutes after admission to the post-anesthesia care unit
Measured: Within 30 minutes of recovery room admission, at evaluable assessments
Secondary outcomes (6)
Maximum PAED Scale Score in Post-Anesthesia Care Unit
From PACU admission to discharge (up to 1 hour).
Measured: From PACU admission to discharge (up to 1 hour)
Incidence of Severe Emergence Agitation (EA) in PACU
Measured: From PACU admission to discharge (up to 1 hour)
Maximum FLACC Pain Score in PACU
Measured: From PACU admission to discharge (up to 1 hour)
Duration of PACU Stay
Measured: From PACU admission to discharge (up to 1 hour)
Use of Rescue Medication in PACU
Measured: From PACU admission to discharge (up to 1 hour)
Compliance with Deep Touch Pressure (DTP) Intervention
Measured: From PACU admission to discharge (up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start4 Sep 2025
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Touch PressureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966466
- Sponsor's protocol ID
- 2503-017-1620
- Acronym
- HUGGY
- Status last verified
- Sep 2026
- First submitted
- 9 May 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Touch Pressure on Emergence Agitation in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06966466
- Acronym / sponsor ID
- HUGGY / 2503-017-1620
- Conditions
- Deep Touch Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTP group | Experimental | Device: HuGgy Compression vest |
| Control group | No intervention | – |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients aged 3 to 10 years scheduled for tonsillectomy and adenoidectomy under general anesthesia.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuGgy Compression vestThis 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. | Device | DTP group |
Primary outcome
Incidence of Emergence Agitation in Post-anesthesia care unit
Time frame: Within 30 minutes of recovery room admission, at evaluable assessments
The incidence of emergence agitation (EA) is defined as a PAED (Pediatric Assessment of Emergence Delirium) scale score 10 or greater within the first 30 minutes after admission to the post-anesthesia care unit
6 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HuGgy Compression vest in people with Deep Touch Pressure, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Emergence Agitation in Post-anesthesia care unit (time frame: Within 30 minutes of recovery room admission, at evaluable assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.