Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children

NCT07472764 | Not Yet Recruiting DMC

• 1 other identifier: TREC2025-KY182
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether auricular acupressure can reduce postoperative emergence agitation among preschool children following adenoidectomy.

Conditions

Emergence Agitation

Keywords

Auricular Acupressure; Emergence agitation; Postoperative pain; non-invasive Traditional Chinese Medicine; Pediatric Anesthesia

Outcome Measures

Primary Outcomes (1)

• The incidence of emergence agitation

  During the anesthesia emergence period assessments were conducted at 5-minute intervals for 15 minutes, recording the Pediatric Anesthesia Emergence Delirium (PAED) scale.The highest recorded score was used, with a PAED score≥10 defined as the occurrence of emergence delirium.The incidence of emergence agitation was calculated according to the scale scores.

  The period from the patient's entry into the Post-Anesthesia Care Unit (PACU) until their discharge from the PACU.

Secondary Outcomes (5)

• the score of FLACC (Face, Legs, Activity, Cry, Consolability)

  During the patient's entire PACU stay.

• Preoperative anxiety score of mYPAS （modified Yale Preoperative Anxiety Scale)

  At the moment before entering the operating room.

• the score of Induction Compliance Checklist during anesthetic induction

  during anesthetic induction

• The incidence of postoperative complications

  PACU stay duration

• the score of Post-Hospitalization Behavior Questionnaire (PHBQ)

  At 1 month and 3 months postoperatively

Study Arms (2)

Auricular acupressure

EXPERIMENTAL

Auricular acupressure is a non-invasive technique derived from traditional Chinese medicine (TCM), where small seeds (typically from Vaccaria segetalis plants) or magnetic beads are attached to specific points on the outer ear using adhesive tape.Patients in the experimental group received auricular acupressure at the following points: Main points: Shenmen (TF4), Endocrine (CO18), Sympathetic (AH6a), Subcortex (AT4); Auxiliary points: Heart (CO15), Liver (CO12), Anterior Lobe (AT3). The location of acupoints was determined in accordance with the World Health Organization (WHO) International Standard Terminologies for Auricular Acupuncture, as specified in WHO Standard Acupuncture Point Locations in the Western Pacific Region (ISBN 978-92-9061-248-7).Acupressure details are as followings: (1) Bilateral ear acupoints. (2) Each point was compressed until deqi was achieved. (3) Deqi manifested as soreness, numbness, distension, or warmth.

Device: Auricular acupressure

Sham Auricular acupressure

SHAM COMPARATOR

For children in the sham stimulation group, we followed the same consultation and auricular point localization procedures, but no Vaccaria seed pressure stimulation was applied. Instead, only an adhesive patch of identical appearance was affixed to the skin.

Device: sham auricular acupressure

Interventions

Auricular acupressure DEVICE

Auricular acupressureis a non-invasive technique derived from traditional Chinese medicine (TCM), where small seeds (typically from Vaccaria segetalis plants) or magnetic beads are attached to specific points on the outer ear using adhesive tape. The location of acupoints was determined in accordance with the World Health Organization (WHO) International Standard Terminologies for Auricular Acupuncture, as specified in WHO Standard Acupuncture Point Locations in the Western Pacific Region (ISBN 978-92-9061-248-7).

Auricular acupressure

sham auricular acupressure DEVICE

For children in the sham stimulation group, we followed the same consultation and auricular point localization procedures, but no Vaccaria seed pressure stimulation was applied. Instead, only an adhesive patch of identical appearance was affixed to the skin.

Sham Auricular acupressure

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• (1) American Society of Anesthesiologists (ASA) physical status classification of I to III; (2) Children aged 3 to 6 years scheduled for elective adenoidectomy; (3) No damage to the epidermis of the external ear.

You may not qualify if:

• (1) Children taking anti-anxiety or antidepressant medications; (2) Children with a history of psychiatric disorders or current psychiatric abnormalities; (3) Children with cognitive deficits or cognitive and intellectual developmental disorders; (4) Children with allergies to auricular acupressure beads; (5) Participation in other clinical trials within the past three months.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing tongren Hospital, Capital Medical University,

Beijing, China

Location

MeSH Terms

Conditions

Emergence Delirium; Pain, Postoperative

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pain

Study Officials

• Guyan Wang

  Beijing Tongren Hospital

  STUDY DIRECTOR

Central Study Contacts

jinhan fan

CONTACT

+86 15040643592; fanjinhan1215@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-02

Locations

CN (1)