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

NCT04094116 | Unknown

• 1 other identifier: WON-20190902-11381
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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 .

Conditions

Cerumen Impaction of Both Ears

Outcome Measures

Primary Outcomes (1)

• The mean number of syringing attempts (50 ml syringe)

  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 Outcomes (1)

• The presence of ear canal abrasion,

  1 month

Study Arms (2)

ear wax syringing with pre ear oil treatment

ACTIVE COMPARATOR

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

ear wax syringing without pre ear oil treatment

SHAM COMPARATOR

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

Interventions

ear wax syringing without pre ear oil treatment PROCEDURE

Active Comparator: ear wax syringing with pre ear oil treatment Sham Comparator: ear wax syringing without pre ear oil treatment

Also known as: ear wax syringing with pre ear oil treatment

ear wax syringing with pre ear oil treatment; ear wax syringing without pre ear oil treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (3)

Fanling Family MEdicine Centre , 1/F , 2 , Pik Fung Road , Fan Ling

Hong Kong, 852, Hong Kong

Location

Tai Po Jockey Club Clinic , 37 Ting Kok Road , Tai Po , Hong Kong

Hong Kong, 852, Hong Kong

Location

Wong Siu Ching Family Medicine centre . 1 , Po Wu Lane , Tai Po

Hong Kong, 852, Hong Kong

Location

Related Publications (1)

• Eekhof JA, de Bock GH, Le Cessie S, Springer MP. A quasi-randomised controlled trial of water as a quick softening agent of persistent earwax in general practice. Br J Gen Pract. 2001 Aug;51(469):635-7.

  PMID: 11510392 RESULT

Related Links

• Related Info

Central Study Contacts

Chang Wells (resident)

CONTACT

97506274; wellschang@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Model Details: non randomised control trials

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: September 18, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)