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Search / Trial NCT06822673

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

Launched by FATIMA JINNAH WOMEN UNIVERSITY · Feb 6, 2025

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Pediatric Primary Headaches Psychological Distress Anxiety, Depression, Stress Emotional Regulation Childhood Trauma Sedentary Behavior Mindfulness Based Intervention Quality Of Life Randomized Controlled Trial Headache Management Non Pharmacological Intervention

ClinConnect Summary

Phases of the Study:

-Phase 1: Screening \& Pre-Intervention Assessment Screening of children (ages 8-12) for primary headaches using standardized diagnostic criteria.

Assessment of biopsychosocial variables through validated psychological scales.

-Phase 2: Randomization \& Intervention Random allocation of children into the intervention group, n=30 (receiving Mindfulness-Based Intervention) and control group, n=30 (receiving no intervention).

The intervention group would undergo an 8-week Mindfulness-Based Program, including techniques such as breathing exercises, guided imagery, body ...

Gender

ALL

Eligibility criteria

  • 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.

About Fatima Jinnah Women University

Fatima Jinnah Women University (FJWU) is a leading educational institution dedicated to advancing women's education and empowerment in Pakistan. Committed to fostering innovative research and development, FJWU serves as a clinical trial sponsor focused on enhancing healthcare outcomes through rigorous scientific inquiry. The university collaborates with various stakeholders to conduct high-quality clinical trials that address pressing health issues, ensuring ethical standards and promoting public health initiatives. Through its initiatives, FJWU aims to contribute significantly to the body of medical knowledge and the improvement of healthcare practices, particularly for women and marginalized communities.

Locations

Rawalpindi, , Pakistan

Patients applied

0 patients applied

Trial Officials

Dr. Iram Gul, PhD

Study Chair

Fatima Jinnah Women University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported