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Efficacy of an educational website on headaches in schoolchildren: A cluster-randomized controlled trial

Goldstein H, Rau LM, Humberg C, Bachhausen V, Stahlschmidt L, Wager J

Headache, 2025

814 participants

Abstract

OBJECTIVE: In this cluster-randomized controlled trial, we developed an educational website on tension-type headache and migraine for children and adolescents and evaluated its effectiveness in a school setting.

BACKGROUND: Primary headaches are a widespread issue in children and adolescents, often persisting into adulthood and associated with considerable disabilities, costs, and reduced quality of life. Effective management of primary headaches may prevent chronicity and its associated consequences.

DESIGN: Guided by a workbook, N = 814 fifth and sixth grade students explored the website during class. Data were collected before the headache education and at three further assessments, each 4 weeks apart, between November 2021 and April 2022. Participants were randomly assigned by class to either the intervention group, which received the website-based educational intervention after the first data collection, or a control group, which accessed the website after the last data collection.

RESULTS: The intervention significantly increased children's headache-related knowledge (time × group interaction: β = 0.35, 95% confidence interval [CI] = [0.30; 0.41], p ≤ 0.001) and resulted in fewer passive pain coping strategies (time × group interaction: β = -0.06, 95% CI = [-0.12; 0.00], p = 0.044). However, the intervention did not significantly reduce the number of days with headaches, use of headache medication, or school absences due to headaches.

CONCLUSION: While the website is…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 814 participants or records.

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