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

NCT ID: NCT06822673

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-06-30

Brief 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.

Detailed Description

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 scanning, and mindful awareness practices.

-Phase 3: Post-Intervention Assessment Re-evaluation of all variables including psychological distress, mindfulness, and quality of life using the same assessment instruments.

Comparison of pre- and post-intervention outcomes.

-Phase 4: Follow-Up (3 Months Post-Intervention) Long-term impact assessment to determine sustained benefits of the intervention.

Ethical Considerations:

• Informed Consent: Parents/guardians will provide written consent before participation.
• Child Assent: Verbal and/or written assent will be obtained from children.
• Confidentiality: All data will be anonymized and securely stored.
• Right to Withdraw: Participants can leave the study at any point without any consequences.
• Free Psychological Support: Children in the intervention group will receive completely free mindfulness-based therapy sessions, and participation in these sessions is voluntary.
• After the study is completed, as an ethical and moral commitment, MBI therapy sessions would be offered to all those children also (who are willing) who were experiencing headaches but did not receive the intervention initially.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Interventional Group (Receiving Mindfulness Based Intervention)

This arm includes children with primary headaches who will undergo the Mindfulness-Based Intervention (MBI). The intervention aims to improve biopsychosocial factors such as mindfulness, emotion regulation, psychological distress, and quality of life.

Group Type: EXPERIMENTAL

Mindfulness Based Intervention

Intervention Type: BEHAVIORAL

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.

Control Group (No Intervention)

This arm consists of children with primary headaches who will not receive any intervention. This group will be used for comparison with Arm 1 to assess the effects of the MBI on biopsychosocial factors and quality of life. Participants in this arm will be assessed at the same time points.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fatima Jinnah Women University

OTHER

Sponsor Role: lead

Responsible Party

Sadia Sohail

Researcher/Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Iram Gul, PhD

Role: STUDY_CHAIR

Fatima Jinnah Women University

Locations

Fatima Jinnah Women University

Rawalpindi, , Pakistan

Countries

Pakistan

Other Identifiers

FJWU/EC/2024/95

Identifier Type: OTHER

Identifier Source: secondary_id

FJWU/EC/2024/95

Identifier Type: -

Identifier Source: org_study_id