Proactive Counselling Towards Follow-ups in Newborn Hearing Screening

NCT04988061 | Withdrawn

• 1 other identifier: 64-220-13-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate if proactive parental educating and counselling can minimize loss to follow-ups of parents whose infant fail newborn hearing screening.

Conditions

Hearing Loss; Newborn Morbidity

Outcome Measures

Primary Outcomes (1)

• Number of participants with loss to follow-ups in all participants whose infants require follow-ups

  A loss to follow-up rate which is calculated from number of participants with loss to follow-ups divided by number of all participants whose infants require follow-ups

  6 months

Study Arms (2)

Counselling arm

EXPERIMENTAL

Educating and Counselling are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.

Other: counselling

standard arm

NO INTERVENTION

The information about hearing screening results and an appointment date are provided as a routine by either nurses or nurse assistances who perform the screening test.

Interventions

counselling OTHER

Educating and Counselling with personal communication for 10-15 minutes and written information about the importance of early identification and intervention for hearing loss are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.

Counselling arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The parents whose infants do not pass hearing screening

You may not qualify if:

• The parents whose infants have illnesses and are not ready for hearing screening
• The parents who decide to migrate to other areas

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 3, 2021
• Study Start: August 20, 2021
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)