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Not yet recruiting NCT07472764

Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children

No phase Interventional Emergence Agitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Auricular acupressure, sham auricular acupressure.
Who it may be relevant to
Registry conditions: Emergence Agitation. Basic parameters: 3 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
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Official title

Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children Undergoing Adenoidectomy: A Prospective, Randomized Controlled Trial

Overview

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

Detailed description

Emergence agitation is a frequent complication after pediatric head and neck surgery. Despite this, evidence for non-pharmacological preventive strategies is limited. This study explores the efficacy of auricular acupressure, a non-invasive Traditional Chinese Medicine technique, in preventing postoperative agitation among these children.

Interventions

  • Device Auricular acupressure
    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
  • Device sham auricular acupressure
    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.

Primary outcome measures

  • The incidence of emergence agitation [Time frame: The period from the patient's entry into the Post-Anesthesia Care Unit (PACU) until their discharge from the PACU.]
Secondary outcome measures (5)
  • the score of FLACC (Face, Legs, Activity, Cry, Consolability) [Time frame: During the patient's entire PACU stay.]
  • Preoperative anxiety score of mYPAS （modified Yale Preoperative Anxiety Scale) [Time frame: At the moment before entering the operating room.]
  • the score of Induction Compliance Checklist during anesthetic induction [Time frame: during anesthetic induction]
  • The incidence of postoperative complications [Time frame: PACU stay duration]
  • the score of Post-Hospitalization Behavior Questionnaire (PHBQ) [Time frame: At 1 month and 3 months postoperatively]

Eligibility criteria

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing tongren Hospital, Capital Medical University, — Beijing

Identifiers

NCT: NCT07472764 · TREC2025-KY182

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗