Proactive Counselling Towards Follow-ups in Newborn Hearing Screening

September 27, 2022 updated by: Pittayapon Pitathawatchai, Prince of Songkla University

Result of Proactive Parental Educating and Counselling Towards Follow-ups in Parents Whose Infant Fail Newborn Hearing Screening

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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 Locations

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Faculty of Medicine, Prince of Songkla University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The parents whose infants do not pass hearing screening

Exclusion Criteria:

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Counselling arm
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
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.
No Intervention: standard arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with loss to follow-ups in all participants whose infants require follow-ups
Time Frame: 6 months
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

Collaborators and Investigators

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

Sponsor

Prince of Songkla University

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 (Actual)

August 20, 2021

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

January 31, 2024

Study Registration Dates

First Submitted

July 28, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64-220-13-1

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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