Prevention of Noise-Induced Hearing Loss in Primary Education

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое HoorToren educational package
  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.

Первичные конечные точки

• 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). [Срок оценки: 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.]

Вторичные конечные точки (3)

• The child's recreational safe listening behavior when using earbuds or headphones with their own smartphone. [Срок оценки: 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 child's psychological determinants of safe listening behavior. [Срок оценки: 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. [Срок оценки: 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.]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Нидерланды · 1 центр

• Erasmus University Medical Center — Rotterdam

Идентификаторы

NCT: NCT07513077 · MEC-2024-0747

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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