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

Sponsor
Hospital Authority, Hong Kong (Other)
Overall Status
Unknown status
CT.gov ID
NCT04094116
Collaborator
(none)
120
Enrollment
3
Locations
2
Arms
12
Anticipated Duration (Months)
40
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase
  • Procedure: ear wax syringing without pre ear oil treatment
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
non randomised control trialsnon randomised control trials
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Effectiveness of Ear Syringing With or Without Pre-Ear Oil Application , Non-randomized Control Trial.
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The mean number of syringing attempts (50 ml syringe) [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 .

    Secondary Outcome Measures

    1. The presence of ear canal abrasion, [1 month]

      The presence of ear canal abrasion,

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 .

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fanling Family MEdicine Centre , 1/F , 2 , Pik Fung Road , Fan Ling Hong Kong Hong Kong 852
    2 Tai Po Jockey Club Clinic , 37 Ting Kok Road , Tai Po , Hong Kong Hong Kong Hong Kong 852
    3 Wong Siu Ching Family Medicine centre . 1 , Po Wu Lane , Tai Po Hong Kong Hong Kong 852

    Sponsors and Collaborators

    • Hospital Authority, Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Chang Wells, resident, Hospital Authority, Hong Kong
    ClinicalTrials.gov Identifier:
    NCT04094116
    Other Study ID Numbers:
    • WON-20190902-11381
    First Posted:
    Sep 18, 2019
    Last Update Posted:
    Sep 18, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 18, 2019