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NCT Number: NCT07513077

Prevention of Noise-Induced Hearing Loss in Primary Education

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.

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Key information

Conditions

Effectiveness of Application Education Intervention Behavior Change Interventions Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Noise-Induced Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Noise Induced Hearing Loss Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Primary School Children Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus University Medical Center

Rotterdam, Netherlands

Location status: Recruiting

Location contact

Willemijn van Diemen, Master of science.

CONTACT

[email protected]

(+31) 06 42 98 71 24

About this study

Results of the currently pending validation study will decide how the primary outcome (the child´s listening behavior) will eventually be defined, i.e. based on the child's versus the parent's report. The child's listening behavior as measured via the smartphone app is an important secondary outcome.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HoorToren educational package

Other

Educational program, consisting of 7 classroom lessons for group 7. Each lesson has an average duration of 30-45 minutes. Parents are targeted in 4 home assignments for the children.

Primary outcomes

  1. The primary outcome is the child's recreational listening behavior when using earbuds or headphones, as reported by either the child or a parent (pending the validation study).

    Time frame: The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention.

    The primary outcome measure will be assessed using newly developed and validated self-report questionnaires for children and parents. The final primary outcome (i.e. either child or parent-reported) will be chosen based on the pending validation study. The outcome will include a composite variable based on the self-reported listening duration and volume. The exact definition will depend on the validation study.

Secondary outcomes

  1. The child's recreational safe listening behavior when using earbuds or headphones with their own smartphone.

    Time frame: The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention.

    This outcome will be objectively measured with a newly developed smartphone application. The composite variable that will be included will be based on the registered listening duration and volume. The exact definition will depend on the validation study.

  2. The child's psychological determinants of safe listening behavior.

    Time frame: The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention.

    These outcomes will be measured using newly developed and validated self-report questionnaires, and are pending the validation study. Examples of determinants are risk perception (susceptibility to, severity of noise-induced hearing loss (NIHL)) and capacity to apply the safe listening behavior.

  3. Parents' psychological determinants related to promoting or facilitating safe listening behavior in their child.

    Time frame: The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention.

    These outcomes will be measured using newly developed and validated self-report questionnaires, and are pending the validation study. Examples of determinants are risk perception (child susceptibility to, severity of NIHL) and capacity to facilitate the child's safe listening behavior.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc van der Schroeff, dr.

CONTACT

[email protected]

Willemijn van Diemen, Master of science.

CONTACT

[email protected]

(+31) 06 42 98 71 24

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Effectiveness of an Educational Program in Primary Schools to Prevent Noise-induced Hearing Loss

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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