Postoperative Middle Ear PressureNCT06605937
The Effect of Postoperative Eustachian Milking Maneuver on Eustachian Tube Dysfunction
An observational study of Postoperative Middle Ear Pressure and Otalgia, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Postoperative Middle Ear Pressure, Otalgia
- What is being tested?
- Eustachian milking maneuver with routine postoperative treatment protocol and Routine postoperative treatment protocol
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2024to 30 Jan 2025
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: 80 patients aged 3-15 years who were indicated for adenoidectomy and/or adenotonsillectomy.
Who may be able to join
- Patients with ASA 1 and 2 The parent will be able to perform eustachian milking manoeuvres
Who cannot join
- Tympanometric examination performed in the preoperative period revealed eustachian dysfunction Craniofacial malformation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital, Karaman
Karaman
About this study
Official title: Eustachian Dysfunction Occurring After Adenoidectomy and/or Adenotonsillectomy and the Effect of Postoperative Eustachian Milking Maneuver on Eustachian Dysfunction
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.
Read the detailed description
The eustachian tube lies between the middle ear and the nasopharyngeal cavity and provides ventilation of the middle ear. The most important function of the Eustachian tube is to balance the air pressure in the middle ear with atmospheric pressure.
Temporary eustachian dysfunction and ear fullness occur in the early postoperative period after adenoidectomy and/or adenotonsillectomy. This temporary eustachian dysfunction is considered to be caused by clots and edema in the nasopharynx after surgery. In addition, trauma to the eustachian tube during adenoidectomy performed by curettage also contributes.
Eustachian dysfunction may present at the post-operative period resulted in otalgia related to middle ear pressure in the pediatric patients undergoing adenoidectomy or adenotonsillectomy. In this case, the need for analgesic agents rises in the early postoperative operiod and beyond this stituation impairs the quality of the healing process.
Reducing middle ear pressure by ensuring the mobility of the eustachian tube with the eustachian milking maneuver, which is a lymphatic drainage method, may reduce the otalgia symptoms during the post-operative recovery period, thus reducing the use of analgesic agents and improving the quality of the healing process. The aim of this observational study is to investigate to what extent a eustachian therapy maneuver corrects the negative values in middle ear pressure in the postoperative period.
- Conditions
- Postoperative Middle Ear Pressure, Otalgia
- Being tested
- Eustachian milking maneuver with routine postoperative treatment protocol, Routine postoperative treatment protocol
- Keywords
- Eustachian Milking Maneuver, Analgesia, Eustachian dysfunction
- Medical subject headings
- Earache, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eustachian milking maneuver with routine postoperative treatment protocolOther
Eustachian milking maneuver will be applied by the patients parents 3 times a day for 7 days in the post-operative period.
Routine postoperative treatment protocolOther
The children adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian healing maneuvers in the post-operative period.
| Study group | Role | What they receive |
|---|---|---|
| Grup 1 | The children undergoing adenoidectomy and/or adenotonsillectomy whose parents will apply eustachian milking maneuver in the post-operative period. Receives: 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. Receives: Other: Routine postoperative treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Perioperative period
Secondary outcomes (1)
Evaluation of postoperative otalgia symptoms
Postoperative pain related to ear will be evaluated with Visual Analog Scale (VAS). Children will be asked to choose the pain they feel according to the facial expression in the picture. 0 indicates no pain, 10 indicates severe pain.
Measured: Postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start22 Oct 2024
- Primary completion30 Dec 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Middle Ear PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayşe Duran, MD, Principal investigator, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605937
- Sponsor's protocol ID
- 04-2024/03
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eustachian Dysfunction Occurring After Adenoidectomy and/or Adenotonsillectomy and the Effect of Postoperative Eustachian Milking Maneuver on Eustachian Dysfunction
- ClinicalTrials.gov ID
- NCT06605937
- Acronym / sponsor ID
- 04-2024/03
- Conditions
- Postoperative Middle Ear Pressure, Otalgia
- Keywords
- Eustachian Milking Maneuver, Analgesia, Eustachian dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The eustachian tube lies between the middle ear and the nasopharyngeal cavity and provides ventilation of the middle ear. The most important function of the Eustachian tube is to balance the air pressure in the middle ear with atmospheric pressure.
Temporary eustachian dysfunction and ear fullness occur in the early postoperative period after adenoidectomy and/or adenotonsillectomy. This temporary eustachian dysfunction is considered to be caused by clots and edema in the nasopharynx after surgery. In addition, trauma to the eustachian tube during adenoidectomy performed by curettage also contributes.
Eustachian dysfunction may present at the post-operative period resulted in otalgia related to middle ear pressure in the pediatric patients undergoing adenoidectomy or adenotonsillectomy. In this case, the need for analgesic agents rises in the early postoperative operiod and beyond this stituation impairs the quality of the healing process.
Reducing middle ear pressure by ensuring the mobility of the eustachian tube with the eustachian milking maneuver, which is a lymphatic drainage method, may reduce the otalgia symptoms during the post-operative recovery period, thus reducing the use of analgesic agents and improving the quality of the healing process. The aim of this observational study is to investigate to what extent a eustachian therapy maneuver corrects the negative values in middle ear pressure in the postoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grup 1 | – | Other: Eustachian milking maneuver with routine postoperative treatment protocol, Other: Routine postoperative treatment protocolThe children undergoing adenoidectomy and/or adenotonsillectomy whose parents will apply eustachian milking maneuver in the post-operative period. |
| Grup 2 | – | Other: Routine postoperative treatment protocolThe children undergoing adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian milking maneuvers in the post-operative period. |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 80 patients aged 3-15 years who were indicated for adenoidectomy and/or adenotonsillectomy.
Key inclusion criteria (1 listed)
- Patients with ASA 1 and 2 The parent will be able to perform eustachian milking manoeuvres
Key exclusion criteria (1 listed)
- Tympanometric examination performed in the preoperative period revealed eustachian dysfunction Craniofacial malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eustachian milking maneuver with routine postoperative treatment protocolEustachian milking maneuver will be applied by the patients parents 3 times a day for 7 days in the post-operative period. | Other | Grup 1 |
| Routine postoperative treatment protocolThe children adenoidectomy and/or adenotonsillectomy whose parents will not apply eustachian healing maneuvers in the post-operative period. | Other | Grup 1, Grup 2 |
Primary outcome
Middle ear pressure
Time frame: Perioperative period
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
1 secondary outcome
Evaluation of postoperative otalgia symptoms
Time frame: Postoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Duran, MD principal investigator
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Middle Ear Pressure and Otalgia, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Middle ear pressure (time frame: Perioperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.