Impact of MBI on Biopsychosocial Factors and QOL in Children With Primary Headaches

* The Randomized Controlled Trial aims to evaluate the effectiveness of a Mindfulness-Based Intervention (MBI) in improving the quality of life and reducing psychological distress in children with primary headaches. This study focuses on children aged 8 to 12 years who experience primary headaches and aims to investigate the biopsychosocial factors influencing their well-being. * The primary objectives of this study are: * To assess the levels of mindfulness, emotional regulation, childhood traumatic experiences, psychological distress, and quality of life in children with and without primary headaches. * To identify the key biopsychosocial factors that impact the quality of life in children experiencing primary headaches. * To evaluate the effectiveness of mindfulness-based interventions in reducing psychological distress and enhancing the quality of life post-intervention. * To compare the differences between the intervention and control groups regarding their biopsychosocial well-being before and after the intervention. * To determine the long-term impact of the mindfulness-based intervention on psychological distress, quality of life, and headache frequency at a three-month follow-up. * Participants in the study will be screened from an initial survey, based on those experiencing headaches and randomly assigned to intervention and control groups. The intervention group will undergo a structured mindfulness-based program, while the control group will receive standard care. Data will be collected at baseline, post-intervention, and during follow-up assessments to measure the intervention's impact. * This study is significant as it aims to address the gaps in current research regarding pediatric primary headaches and their effect on psychological and social well-being. The findings may provide valuable insights for healthcare professionals to develop effective, non-pharmacological interventions to improve the quality of life of children suffering from primary headaches in Pakistan.

NCT Number	NCT06822673
Lead Sponsor	Fatima Jinnah Women University
Conditions	Primary Headache, Psychological Distress, Emotion Regulation, Childhood Trauma, Sedentary Behaviors, Mindfulness, Health-Related Quality-of-Life
Enrollment	60 participants
Start Date	2025-01-01
Primary Completion	2025-04 (estimated)
Study Completion	2025-06 (estimated)
Updated on ClinicalTrials.gov	2025-02-12