Laser Acupuncture for Otitis Media With Effusion in Children

The goal of this clinical trial is to learn if laser acupuncture (LA) can improve middle ear function and reduce the recurrence of Otitis Media with Effusion (OME) in children. The main questions it aims to answer are: Does LA, when combined with standard treatment (decongestants), improve middle ear function as measured by tympanometry immediately after the 2-week intervention? Does LA, when combined with standard treatment, reduce the recurrence rate of OME as monitored over a 1-month period after the intervention? What is the safety profile of LA in this population, as measured by the incidence of adverse events? Researchers will compare active LA to sham LA (a placebo procedure with an inactive device) to determine if LA leads to meaningful improvements in children with OME. Participants will: Complete an initial assessment using tympanometry to confirm the diagnosis. Receive four sessions of either active LA or sham LA over a 2-week period. Complete a final assessment using tympanometry after the final session. Participate in a 1-month follow-up period with weekly monitoring for recurrence.

NCT Number	NCT07242001
Lead Sponsor	Indonesia University
Conditions	Otitis Media With Effusion
Enrollment	32 participants
Start Date	2025-12-29
Primary Completion	2026-03-26 (estimated)
Study Completion	2026-04-22 (estimated)
Updated on ClinicalTrials.gov	2026-06-04