Comparison of Effectiveness of Ear Syringing With or Without Pre-Ear Oil Application , Non-randomized Control Trial.

September 17, 2019 updated by: Chang Wells, Hospital Authority, Hong Kong
Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application. On the other hand, patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing. We will compare the respective success rates of ear syringing from these 2 groups, the mean numbers of syringing attempts, subjective improvement in hearing , as well as any complications such as ear canal abrasion, ear drum perforation, any pain or vertigo reported by patients. For those cases who fail ear syringing , olive oil will be prescribe and arrange 1 week follow up for ear syringing .

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Fanling Family MEdicine Centre , 1/F , 2 , Pik Fung Road , Fan Ling
        • Contact:
      • Hong Kong, Hong Kong, 852
        • Tai Po Jockey Club Clinic , 37 Ting Kok Road , Tai Po , Hong Kong
        • Contact:
      • Hong Kong, Hong Kong, 852
        • Wong Siu Ching Family Medicine centre . 1 , Po Wu Lane , Tai Po
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients >18 years old, who complain about blocked ear found to have ear wax which impacts ear drum and able to sign consent.

Exclusion Criteria:

  • Patients who are contraindicated to ear syringing will be excluded : otitis externa , otitis media , history of tympanic membrane perforation , history or ear surgery , unilateral deafness , in-co-operated patient (eg. Children ) , history of vertigo after ear syringing .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ear wax syringing with pre ear oil treatment
patients in Fanling Family Medicine Centre with ear wax will be given ear oil one week before performing ear syringing.
Procedure: ear wax syringing without pre ear oil treatment
Active Comparator: ear wax syringing with pre ear oil treatment Sham Comparator: ear wax syringing without pre ear oil treatment
Other Names:
  • ear wax syringing with pre ear oil treatment
Sham Comparator: ear wax syringing without pre ear oil treatment
Patients in Wong Siu Ching Clinic and Tai Po Clinic who are found to have ear wax after physical examination will have ear syringing done, without pre-ear oil application.
Procedure: ear wax syringing without pre ear oil treatment
Active Comparator: ear wax syringing with pre ear oil treatment Sham Comparator: ear wax syringing without pre ear oil treatment
Other Names:
  • ear wax syringing with pre ear oil treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean number of syringing attempts (50 ml syringe)
Time Frame: 1 day
For both groups the mean number of syringing attempts (and 95% confidence interval) is calculated and compared by testing the difference between the means, using a t test for independent samples. For patients with persistent earwax in both ears , the mean number of syringing attempts needed for both ears in one patient is used for the calculations . All ears in which the wax is still persistent after another 10 syringing attempts are given a value of 11 in the calculations . Data for this study is analyzed using SPSS version 26 .
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence of ear canal abrasion,
Time Frame: 1 month
The presence of ear canal abrasion,
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 14, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 18, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • WON-20190902-11381

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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