Emergence AgitationNCT07472764
Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children
A study testing Auricular acupressure in people with Emergence Agitation, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
This study investigates whether auricular acupressure can reduce postoperative emergence agitation among preschool children following adenoidectomy. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Auricular acupressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing tongren Hospital, Capital Medical University,
Beijing
jinhan fan, +86 15040643592, fanjinhan1215@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Emergence Agitation
- Being tested
- Auricular acupressure, sham auricular acupressure
- Keywords
- Auricular Acupressure, Emergence agitation, Postoperative pain, non-invasive Traditional Chinese Medicine, Pediatric Anesthesia
- Medical subject headings
- Emergence Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupressureDevice
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 acupressureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: sham auricular acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.)
Measured: During the patient's entire PACU stay.
Preoperative anxiety score of mYPAS （modified Yale Preoperative Anxiety Scale)
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.
Measured: At the moment before entering the operating room.
the score of Induction Compliance Checklist 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.
Measured: during anesthetic induction
The incidence of postoperative complications
The incidence of postoperative complications such as nausea and vomiting, coughing, laryngospasm or bronchospasm, bradycardia , and oxygen desaturation, along with PACU stay duration.
Measured: PACU stay duration
the score of Post-Hospitalization Behavior Questionnaire (PHBQ)
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.
Measured: At 1 month and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- More trials run by Beijing Tongren 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guyan Wang, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472764
- Sponsor's protocol ID
- TREC2025-KY182
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children Undergoing Adenoidectomy: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07472764
- Acronym / sponsor ID
- TREC2025-KY182
- Conditions
- Emergence Agitation
- Keywords
- Auricular Acupressure, Emergence agitation, Postoperative pain, non-invasive Traditional Chinese Medicine, Pediatric Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupressure | Experimental | Device: Auricular acupressureAuricular 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. |
| Sham Auricular acupressure | Sham comparator | Device: sham auricular acupressureFor 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
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 |
|---|---|---|
| Auricular acupressureAuricular 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). | Device | Auricular acupressure |
| sham auricular acupressureFor 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 |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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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.
Guyan Wang study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupressure in people with Emergence Agitation, run by Beijing Tongren Hospital at 1 site in China.
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 1 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: opening soon, as of the sponsor's last update on 16 Mar 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jinhan fan (+86 15040643592, fanjinhan1215@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 16 Mar 2026.