Effectiveness of Application Education InterventionNCT07513077
Prevention of Noise-Induced Hearing Loss in Primary Education
A study testing HoorToren educational package in people with Effectiveness of Application Education Intervention and Noise Induced Hearing Loss, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Effectiveness of Application Education Intervention, Noise Induced Hearing Loss, Behavior Change Interventions
- What is being tested?
- HoorToren educational package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Mar 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marc van der Schroeff, dr. contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam
Willemijn van Diemen, Master of science., (+31) 06 42 98 71 24, w.vandiemen@erasmusmc.nl
About this study
Official title: Effectiveness of an Educational Program in Primary Schools to Prevent Noise-induced Hearing Loss
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.
Read the 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.
- Conditions
- Effectiveness of Application Education Intervention, Noise Induced Hearing Loss, Behavior Change Interventions, Primary School Children
- Being tested
- HoorToren educational package
- Keywords
- Noise-induced hearing loss, Prevention, Primary school, Randomized controlled trial, Effectiveness
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoorToren educational packageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | In this arm students receive seven lessons of the educational program the HoorToren, including 4 home assignments also targeting parents. Receives: Other: HoorToren educational package |
| Control arm | No intervention | In this arm students receive no lessons of the educational program the HoorToren. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (3)
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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start30 Mar 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Application Education InterventionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc P. van der Schroeff, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513077
- Sponsor's protocol ID
- MEC-2024-0747
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Program in Primary Schools to Prevent Noise-induced Hearing Loss
- ClinicalTrials.gov ID
- NCT07513077
- Acronym / sponsor ID
- MEC-2024-0747
- Conditions
- Effectiveness of Application Education Intervention, Noise Induced Hearing Loss, Behavior Change Interventions, Primary School Children
- Keywords
- Noise-induced hearing loss, Prevention, Primary school, Randomized controlled trial, Effectiveness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: HoorToren educational packageIn 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- For schools: None.
- Dutch primary school children in group 7 (corresponding to Year 6 in the UK).
- Informed consent from legally authorized parent(s) or guardian(s).
- Child is participating.
Key exclusion criteria (7 listed)
- HoorToren package has been taught at group 6 in the previous school year.
- Children without informed consent from legally authorized parent(s) or guardian(s).
- Children who cannot read and write Dutch.
- Parents who cannot read and write Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoorToren educational packageEducational 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. | Other | Intervention arm |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marc van der Schroeff, dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoorToren educational package in people with Effectiveness of Application Education Intervention and Noise Induced Hearing Loss, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Willemijn van Diemen, Master of science. ((+31) 06 42 98 71 24, w.vandiemen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.