Prevention of Noise-Induced Hearing Loss in Primary Education
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HoorToren educational package.
- Who it may be relevant to
- Registry conditions: Effectiveness of Application Education Intervention, Noise Induced Hearing Loss, Behavior Change Interventions, Primary School Children. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of an Educational Program in Primary Schools to Prevent Noise-induced Hearing Loss
Overview
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.
Detailed description
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.
Interventions
- Other 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.
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- 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.]
- 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.]
- 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Netherlands · 1 center
- Erasmus University Medical Center — Rotterdam
Identifiers
NCT: NCT07513077 · MEC-2024-0747