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NCT Number: NCT07472764

Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children

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

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

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

    Time frame: During the patient's entire PACU stay.

    Pain in pediatric patients was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, and scores were compared between the two groups.Full name of the FLACC Postoperative Pain Rating Scale:Face (Facial Expression) , Legs (Lower Limb Posture), Activity (Activity Level), Cry (Crying), Consolability (Consolability).Each item is scored from 0 to 2 points. Total score range: 0-10 points.

    Total Score Interpretation Lowest score: 0 points → Indicates no signs of pain. Highest score: 10 points → Indicates severe pain. Score meaning: A higher score indicates more severe pain and a worse outcome. (Note: The FLACC scale assesses pain intensity; high scores require medical intervention for pain relief.)

  2. Preoperative anxiety score of mYPAS (modified Yale Preoperative Anxiety Scale)

    Time frame: At the moment before entering the operating room.

    Using the modified Yale Preoperative Anxiety Scale (mYPAS) criteria, anxiety levels were assessed at the time of parent-child separation and subsequently compared.Modified Yale Preoperative Anxiety Scale rates a child's behavior in specific preoperative settings through observation. It comprises 5 core domains, include activity, vocalizations, emotional expressivity, state of arousal and Use of Parent, each scored based on observed behaviors. Domain scores are not evenly weighted; the total score is the sum of the actual scores from each domain after conversion.

    Lowest possible score: Approximately 23.3 points (result of standardizing the sum of the lowest domain scores; raw behavioral scores are converted via formula into a standardized total).

    Highest possible score: 100 points (standardized maximum). Score meaning: A higher score indicates a greater degree of preoperative anxiety, representing a worse outcome.

  3. the score of Induction Compliance Checklist during anesthetic induction

    Time frame: during anesthetic induction

    During anesthetic induction patient compliance was assessed using the Induction Compliance Checklist (ICC).This scale is used to assess a child's behavioral compliance during the anesthesia induction phase. It consists of 5 levels, with a single overall score assigned based on the child's behavior ranging from cooperative to completely uncooperative.

    0 Points - Excellent Compliance

    • Point - Slight Resistance
    • Points - Moderate Resistance
    • Points - Severe Resistance
    • Points - Total Noncompliance Lowest Score: 0 points → Indicates full cooperation and a smooth induction process Highest Score: 4 points → Indicates total noncooperation and a difficult induction process Score Meaning: A higher score indicates poorer compliance, greater difficulty during anesthesia induction, and a worse clinical outcome.
  4. The incidence of postoperative complications

    Time frame: PACU stay duration

    The incidence of postoperative complications such as nausea and vomiting, coughing, laryngospasm or bronchospasm, bradycardia , and oxygen desaturation, along with PACU stay duration.

  5. the score of Post-Hospitalization Behavior Questionnaire (PHBQ)

    Time frame: At 1 month and 3 months postoperatively

    Follow-ups were conducted with the children's guardians at 1 month and 3 months postoperatively using the Post-Hospitalization Behavior Questionnaire (PHBQ), and the scores were compared between the two groups.

    Scoring Criteria (Per Item):

    • point: No change in behavior
    • points: Mild worsening of behavior
    • points: Significant worsening of behavior
    • points: Extreme worsening of behavior
    • points: Marked as "Not Applicable" Core Behavioral Dimensions and Example Items 1. General Anxiety/Withdrawal 2. Separation Anxiety 3. Sleep Disturbance 4. Eating Pattern Change 5. Aggression/Antagonism 6. Regression Lowest Possible Score: 27 points (all items rated "no change") Highest Possible Score: 108 points (all items rated "extreme worsening," with no "not applicable" items) Score Meaning: A higher score indicates more severe postoperative behavioral problems and a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

jinhan fan

CONTACT

[email protected]

+86 15040643592

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 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.

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