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Recruiting NCT07513077

NCT07513077 Prevention of Noise-Induced Hearing Loss in Primary Education

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Clinical Trial Summary
NCT ID NCT07513077
Status Recruiting
Phase
Sponsor Erasmus Medical Center
Condition Effectiveness of Application Education Intervention
Study Type INTERVENTIONAL
Enrollment 600 participants
Start Date 2026-03-30
Primary Completion 2027-08

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age N/A
Study Type INTERVENTIONAL
Interventions
HoorToren educational package

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 600 participants in total. It began in 2026-03-30 with a primary completion date of 2027-08.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The goal of this randomized controlled trial is to evaluate the effectiveness of the educational program the HoorToren in promoting recreational safe listening behavior among Dutch primary school children in group 7 (aged 10-11 years) and thereby contribute to preventing noise-induced hearing loss. The main objectives are: * To evaluate the HoorToren's effects on promoting the child's safe listening behavior when using headphones or earbuds. Both safe listening and its psychological determinants will be measured. * To evaluate the HoorToren's effects on parents' perception of their child's safe listening behaviors. The effects on parental behavior promoting or facilitating their child's safe listening behavior, including its psychological determinants, will also be evaluated. Researchers will compare children who receive lessons from the HoorToren educational program, and their parents (intervention group) with children and their parents who do not receive the lessons (control group) to evaluate the effectiveness of the HoorToren. Outcomes will be assessed using newly developed and validated self-report questionnaires for both children and their parents. Additionally, the child's listening behavior will be measured via a smartphone application installed on the child's phone. Measurements will take place at four time points during the school year.

Eligibility Criteria

Inclusion Criteria: For schools: None. For children: * Dutch primary school children in group 7 (corresponding to Year 6 in the UK). * Informed consent from legally authorized parent(s) or guardian(s). Parents: • Child is participating. Exclusion Criteria: For schools: • HoorToren package has been taught at group 6 in the previous school year. For children: * Children without informed consent from legally authorized parent(s) or guardian(s). * Children who cannot read and write Dutch. For parents: • Parents who cannot read and write Dutch

Contact & Investigator

Central Contact

Willemijn van Diemen, Master of science.

✉ w.vandiemen@erasmusmc.nl

📞 (+31) 06 42 98 71 24

Frequently Asked Questions

Who can join the NCT07513077 clinical trial?

This trial is open to participants of all sexes, studying Effectiveness of Application Education Intervention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07513077 currently recruiting?

Yes, NCT07513077 is actively recruiting participants. Contact the research team at w.vandiemen@erasmusmc.nl for enrollment information.

Where is the NCT07513077 trial being conducted?

This trial is being conducted at Rotterdam, Netherlands.

Who is sponsoring the NCT07513077 clinical trial?

NCT07513077 is sponsored by Erasmus Medical Center. The trial plans to enroll 600 participants.

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