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 range

8 Years – 12 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

8 Years – 12 Years

Sex

ALL

See this in plain English?

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