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

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.

Conditions

• Primary Headache
• Psychological Distress
• Emotion Regulation
• Childhood Trauma
• Sedentary Behaviors
• Mindfulness
• Health-Related Quality-of-Life

Interventions

BEHAVIORAL

Mindfulness Based Intervention

The Mindfulness-Based Intervention will include techniques derived from the Mindfulness Matters Program protocol (for Children and Adolescents, 2019). It will consist of both formal and informal practices, which participants will engage in during sessions and at home. These practices will encompass body scan meditation, mindful eating, mindful sitting, walking exercises, attention-focusing activities, and more. The intervention will be delivered over eight weekly sessions, following a skill-building, educational approach.

Sponsors & Collaborators

• Fatima Jinnah Women University

  lead OTHER

Principal Investigators

• Dr. Iram Gul, PhD · Fatima Jinnah Women University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2025-04-30

Completion

2025-06-30

Countries

• Pakistan

Study Locations