By InvitationNot Applicable

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

Pakistan60 participantsStarted 2025-01-01

Plain-language summary

* 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.

Who can participate

Age range8 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged between 8 to 12 years * From an initial survey, those who experience headaches would be screened * Children who are able to read and understand the English language, as the assessment instruments are in English, will be included. * Both the children and their parents must consent to the child's participation in the study. Exclusion Criteria: * Children who are not students will be excluded from the study. * Children with any diagnosed genetic disease or disorder, chronic disease, or disability will be excluded. * Children with a current or past psychiatric disorder, especially those who have received treatment or medication for such conditions in the past year, will be excluded. * Children who have been on any long-term medication for any disease or disorder will be excluded, as this may influence the results of the study.

What they're measuring

Health-Related Quality-of-Life

Timeframe: 10-12 weeks

Pediatric Headaches

Timeframe: 10-12 weeks

Mindfulness

Timeframe: 10-12 weeks

Trial details

NCT IDNCT06822673

SponsorFatima Jinnah Women University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04

View on ClinicalTrials.gov More Primary Headache trials

Plain-language summary

Who can participate

Age range8 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.