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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | In this arm students receive seven lessons of the educational program the HoorToren, including 4 home assignments also targeting parents. |
|
| Control arm | No Intervention | In this arm students receive no lessons of the educational program the HoorToren. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The child's recreational safe listening behavior when using earbuds or headphones with their own smartphone. | 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. | 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. |
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Inclusion Criteria:
For schools: None.
For children:
Parents:
• Child is participating.
Exclusion Criteria:
For schools:
• HoorToren package has been taught at group 6 in the previous school year.
For children:
For parents:
• Parents who cannot read and write Dutch
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Willemijn van Diemen, Master of science. | Contact | (+31) 06 42 98 71 24 | w.vandiemen@erasmusmc.nl | |
| Marc van der Schroeff, dr. | Contact | m.vanderschroeff@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center | Recruiting | Rotterdam | Netherlands |
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| ID | Term |
|---|---|
| D006317 | Hearing Loss, Noise-Induced |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
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| The child's psychological determinants of safe listening behavior. | 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. | 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. |
| Parents' psychological determinants related to promoting or facilitating safe listening behavior in their child. | 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. | 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. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |