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"Transcutaneous auricular vagus nerve stimulation" improves recovery quality after tonsil and/or adenoidectomy in children (PedSQoR): a multicenter, randomized, double-blind controlled trial

"Transcutaneous auricular vagus nerve stimulation" improves recovery quality after tonsil and/or adenoidectomy in children (PedSQoR): a multicenter, randomized, double-blind controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126313
Enrollment
Unknown
Registered
2026-06-07
Start date
2026-06-10
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillar or Adenoidal Hypertrophy

Interventions

ta-VNS group :The active stimulation group received active electrical stimulation of the left concha cymba (stimulation frequency 10 Hz, pulse width 200µs, 30 seconds on/30 seconds off). The first sti
Sham stimulation group:The sham stimulation group received treatment with the same cycle. Sham stimulation was delivered via electrodes placed on the left concha of the ear, with stimulus intensity ad

Sponsors

Heping Hospital Affiliated to Changzhi Medical College, Changzhi , Shanxi, China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 5–12 years; 2. Patients diagnosed with tonsillar and/or adenoidal hypertrophy at the Affiliated Heping Hospital of Changzhi Medical College in Shanxi Province or the Women and Children's Health Care Hospital of Changzhi City, Shanxi Province, who are scheduled to undergo tonsillectomy and/or adenoidectomy under general anesthesia; 3. American Society of Anesthesiologists (ASA) physical status classification I–II; 4. The child/patient and guardian can understand the content of the Chinese version of the scale and cooperate with the relevant assessment.

Exclusion criteria

Exclusion criteria: 1. Combined with severe organ dysfunction; 2. Individuals with skin damage, dermatitis, infection, eczema, or other lesions unsuitable for ear stimulation/treatment in the intended stimulated ear area; 3. Children with respiratory tract infections within the past 2 weeks or previously diagnosed with developmental delay or autism; 4. Participants in other clinical trials; 5. Individuals with implanted electronic devices (e.g., pacemakers, implantable cardioverter-defibrillators); 6. Those with a history of epileptic seizures or syncope recurrence within the past 5 years; 7. Individuals who received vagus nerve stimulation or acupuncture treatment within 1 month prior to the study.

Design outcomes

Primary

MeasureTime frame
Pediatric Scale for Quality of Recovery;

Secondary

MeasureTime frame
Postoperative pain scores and pain incidence rate;The incidence of delirium during the emergence period;Recovery time;Nausea and vomiting;Adverse event;

Countries

China

Contacts

Public ContactFan Qin

Heping Hospital Affiliated to Changzhi Medical College, Changzhi , Shanxi, China.

fanqin@czmc.edu.cn+86 355 312 8031

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026