Clinical trial NCT06816849: Hydration in Children and Adolescents With Primary Headaches
Official title: The Role of Hydration in the Management of Pediatric Primary Headaches: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
Hydration
Adolescent
Children
Keywords: primary headache
pediatric
children
hydration
water intake
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache frequency
timeFrame: 4 months
measure: Headache intensity
timeFrame: 4 months
measure: Headache duration
timeFrame: 4 months
Secondary outcomes:
measure: Change in total body water
timeFrame: 4 months
measure: Effect of nutritional advice on type of drink they have choosen
timeFrame: 4 months
measure: Change in extracellular water
timeFrame: 4 months
measure: Change in phase angle
timeFrame: 4 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References:
citation: Spigt MG, Kuijper EC, Schayck CP, Troost J, Knipschild PG, Linssen VM, Knottnerus JA. Increasing the daily water intake for the prophylactic treatment of headache: a pilot trial. Eur J Neurol. 2005 Sep;12(9):715-8. doi: 10.1111/j.1468-1331.2005.01081.x.
citation: Spigt M, Weerkamp N, Troost J, van Schayck CP, Knottnerus JA. A randomized trial on the effects of regular water intake in patients with recurrent headaches. Fam Pract. 2012 Aug;29(4):370-5. doi: 10.1093/fampra/cmr112. Epub 2011 Nov 23.
citation: Khorsha F, Mirzababaei A, Togha M, Mirzaei K. Association of drinking water and migraine headache severity. J Clin Neurosci. 2020 Jul;77:81-84. doi: 10.1016/j.jocn.2020.05.034. Epub 2020 May 20.