An interventional study of Recommended water intake in Primary Headaches (Includes Migraines, Tension, Cluster Headaches), Hydration and Adolescent, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-02-10.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment
The aim of this study is to investigate the role of hydration and fluid intake in children and adolescents with primary headaches.
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.
120 studies on the registry are indexed under Cluster Headache; 28 are open to participants now.
This study's enrollment of 60 is above the median of 42 across 88 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →University Medical Centre Ljubljana is the lead sponsor of 293 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
All participants received personalized consultation from a dietitian on adequate fluid intake and the selection of drinks based on dietary guidelines. They were required to follow the intervention for four months.
Other: Recommended water intake
All participants received personalized consultation from a dietitian on adequate fluid intake and the selection of drinks based on dietary guidelines. They were required to follow the intervention for four months.
Headache frequency
Number of headache episodes over last three months.
Time frame: 4 months
Headache intensity
Headache severity measured with the Visual Analog Scale (0 - 10).
Time frame: 4 months
Headache duration
Average length of headache episode measured in minutes.
Time frame: 4 months
Change in total body water
Change in total body water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Time frame: 4 months
Effect of nutritional advice on type of drink they have choosen
Type of fluid they had increased during intervention.
Time frame: 4 months
Change in extracellular water
Change in extracellular water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Time frame: 4 months
Change in phase angle
Change in phase angle (°) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Time frame: 4 months
Plan to share: No
Ran from Mar 2023 to primary completion in Oct 2023, 7 months.
Of 26 interventional studies with no phase under Cluster Headache, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 25. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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