Actively Recruiting
Laser Acupuncture for Otitis Media With Effusion in Children
Led by Indonesia University · Updated on 2026-02-05
32
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Laser Acupuncture for Otitis Media With Effusion in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 10 years, male or female
- Diagnosed with Otitis Media with Effusion showing a Type B tympanogram curve, unilateral or bilateral
- No acute ear infection within the last 2 weeks
- Willing to participate for the full study duration with signed parental or guardian consent
You will not qualify if you...
- History of tympanic membrane perforation or previous ear surgery
- Severe OME complications such as permanent hearing loss, tympanosclerosis, or cholesteatoma
- Received laser acupuncture for OME within the last 3 months
- History of unstable systemic disease or medical conditions interfering with the study (including uncontrolled seizures, epilepsy, high fever over 38°C, or ENT cancers)
- Mental disorders, communication difficulties, or uncooperative behavior
- Wounds or skin lesions at planned acupuncture points
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Actively Recruiting
Research Team
A
Agitha M Putri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here