Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children

March 12, 2026 updated by: Beijing Tongren Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Beijing tongren Hospital, Capital Medical University,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular acupressure
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
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 Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
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.

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.
At the moment before entering the operating room.
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

  1. Point - Slight Resistance
  2. Points - Moderate Resistance
  3. Points - Severe Resistance
  4. 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.
during anesthetic induction
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.
PACU stay duration
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):

  1. point: No change in behavior
  2. points: Mild worsening of behavior
  3. points: Significant worsening of behavior
  4. points: Extreme worsening of behavior
  5. 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.
At 1 month and 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Investigators

  • Study Director: Guyan Wang, Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREC2025-KY182

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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