The Effectiveness of Laser Acupuncture in the Management of Otitis Media With Effusion in Children

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 10
Healthy Volunteers: f
View:

• Children aged 2-10 years, both male and female.

• Diagnosed with OME with a Type B tympanogram curve, either unilateral or bilateral.

• No acute ear infection within the last 2 weeks.

• Willingness to participate in the study until completion and signed informed consent from a parent or legal guardian.

Locations
Other Locations
Indonesia
Universitas Indonesia
RECRUITING
Jakarta Pusat
Contact Information
Primary
Agitha M Putri
agitha.melita@ui.ac.id
082114568788
Time Frame
Start Date: 2025-12-29
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 32
Treatments
Experimental: Intervention Group
Active laser acupuncture and standard decongestants.
Sham_comparator: Control Group
Sham laser acupuncture and standard decongestants.
Related Therapeutic Areas
Sponsors
Leads: Indonesia University

This content was sourced from clinicaltrials.gov