Hydration in Children and Adolescents With Primary Headaches

Not Applicable

Completed

• Conditions: Primary Headaches (Includes Migraines, Tension, Cluster Headaches); Hydration; Adolescent; Children

• Registration Number: NCT06816849
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

The aim of this study is to investigate the role of hydration and fluid intake in children and adolescents with primary headaches.

Detailed Description

Headches are one of the key factors affecting or even limiting the health and well-being of children and adolescents. Lifestyle recommendations could help reduce the risk of chronic headaches and improve overall well-being in this population. In clinical practice, adequate fluid intake is one of the general recommendations for headache management. However, scientific literature on the role of hydration and fluid intake in headaches is limited. To date, all studies have been conducted on adults, and no studies have examined this topic in the pediatric population.

As the first interventional study investigating the impact of adequate fluid intake on headaches in children and adolescents, our study will make a significant contribution to understanding the role of hydration in headache management and developing recommendations for improving headache control in the pediatric population.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-01
• Primary Completion: 2023-10-31
• Study Completion: 2024-06-30
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-10
• Last Update Posted: 2025-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age 4-18 years.
• Able to provide informed consent and willing to complete follow-up visits.
• Primary headaches.
• At least 1 headache per month.
• Presence of headaches for at least 3 months or longer.

Exclusion Criteria

• Secondary headaches.
• Without headaches for 3 months or more.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Headache frequency	4 months	Number of headache episodes over last three months.
Headache duration	4 months	Average length of headache episode measured in minutes.
Headache intensity	4 months	Headache severity measured with the Visual Analog Scale (0 - 10).

Secondary Outcome Measures

Name	Time	Method
Change in phase angle	4 months	Change in phase angle (°) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Change in total body water	4 months	Change in total body water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Effect of nutritional advice on type of drink they have choosen	4 months	Type of fluid they had increased during intervention.
Change in extracellular water	4 months	Change in extracellular water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia