The Effect of Postoperative Eustachian Milking Maneuver on Eustachian Tube Dysfunction

NCT06605937 | Completed DMC

• 1 other identifier: 04-2024/03
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of this lymphatic drainage method in eliminating otalgia interruption due to eustachian dysfunction and reducing middle ear pressure, which occurs in the postoperative period after adenoidectomy and/or adenotonsillectomy.

Conditions

Postoperative Middle Ear Pressure; Otalgia

Keywords

Eustachian Milking Maneuver; Analgesia; Eustachian dysfunction

Outcome Measures

Primary Outcomes (1)

• Middle ear pressure

  Tympanometry is an objective test of middle-ear function. The test is performed by inserting the tympanometer probe in the ear canal. The instrument changes the pressure in the ear, generates a pure tone, and measures the eardrum responses to the sound at different pressures. This produces a series of data measuring how admittance varies with pressure, which is plotted as a tympanogram

  Perioperative period

Secondary Outcomes (1)

• Evaluation of postoperative otalgia symptoms

  Postoperative period

Study Arms (2)

Grup 1

The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will apply eustachian milking maneuver in the post-operative period.

Other: Eustachian milking maneuver with routine postoperative treatment protocol; Other: Routine postoperative treatment protocol

Grup 2

The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian milking maneuvers in the post-operative period.

Other: Routine postoperative treatment protocol

Interventions

Eustachian milking maneuver with routine postoperative treatment protocol OTHER

Eustachian milking maneuver will be applied by the patients parents 3 times a day for 7 days in the post-operative period.

Grup 1

Routine postoperative treatment protocol OTHER

The children adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian healing maneuvers in the post-operative period.

Grup 1; Grup 2

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

80 patients aged 3-15 years who were indicated for adenoidectomy and/or adenotonsillectomy.

You may qualify if:

• Patients with ASA 1 and 2 The parent will be able to perform eustachian milking manoeuvres

You may not qualify if:

• Tympanometric examination performed in the preoperative period revealed eustachian dysfunction Craniofacial malformation

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman Training and Research Hospital, Karaman

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Earache; Agnosia

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Ayşe Duran, MD

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: October 22, 2024
• Primary Completion: December 30, 2024
• Study Completion: January 30, 2025
• Last Updated: April 17, 2025

Record last verified: 2024-09

Locations

TU (1)