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

NCT06822673 | Enrolling By Invitation DMC

• 1 other identifier: FJWU/EC/2024/95
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (3)

• Health-Related Quality-of-Life

  * Health-Related Quality of life refers to an individual's overall physical, social and emotional well-being related to health. * Measurement Tool: Pediatric Quality of Life Inventory (PedsQL) * Unit of Measure: Total score on PedsQL, with higher scores indicating better quality of life. * Detail: The PedsQL consists of multiple items assessing the impact of health conditions on a child's daily functioning. The scale evaluates the overall Health-Related Quality of life by aggregating responses across all items and domains. The total score is computed as the mean of all responded items.

  10-12 weeks

• Pediatric Headaches

  * This outcome measure assesses the severity of headaches experienced by children. * Measurement Tool: Headache Screening Questionnaire (HSQ) * Unit of Measure: Total score, with higher values indicating greater headache severity. * Description: The HSQ consists of questions addressing headache related symptoms. This outcome would measure the changes in headache characteristics in response to MBI.

  10-12 weeks

• Mindfulness

  * Mindfulness refers to the practice of present moment awareness. * Measurement Tool: Child and Adolescent Mindfulness Measure (CAMM) * Unit of Measure: Total CAMM score, with higher scores indicating greater mindfulness. * Detail: Mindfulness will be evaluated to determine whether MBI changes children's ability to focus on the present moment.

  10-12 weeks

Secondary Outcomes (4)

• Psychological Distress

  10-12 weeks

• Emotion Regulation

  10-12 weeks

• Childhood Traumatic Experiences

  10-12 weeks

• Sedentary Behaviors

  10-12 weeks

Study Arms (2)

Interventional Group (Receiving Mindfulness Based Intervention)

EXPERIMENTAL

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.

Behavioral: Mindfulness Based Intervention

Control Group (No Intervention)

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.

Interventions

Mindfulness Based Intervention 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.

Interventional Group (Receiving Mindfulness Based Intervention)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fatima Jinnah Women University: lead

Study Sites (1)

Fatima Jinnah Women University

Rawalpindi, 46000, Pakistan

Location

MeSH Terms

Conditions

Emotional Regulation; Sedentary Behavior; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Mental Disorders; Behavioral Symptoms

Study Officials

• Dr. Iram Gul, PhD

  Fatima Jinnah Women University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher/Student

Model Details: The interventional study model for this research follows a randomized controlled trial (RCT) design, which aims to evaluate the effectiveness of a Mindfulness-Based Intervention (MBI) in managing biopsychosocial factors associated with quality of life in children with primary headaches. Participants will be randomly assigned to either the intervention group, which will receive the MBI, or the control group, which will not receive any intervention. The study will adopt a pre-test, post-test, and follow-up assessment approach to measure changes in key variables, including psychological distress, emotion regulation, childhood traumatic experiences, sedentary behaviors, quality of life, mindfulness, and pediatric headache symptoms. The trial is currently in Phase 1, following the successful completion of pilot testing. At this stage, participants are being recruited for data collection.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 12, 2025
• Study Start: January 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: The data will be available after study completion and publication of primary findings (tentatively from December, 2025) and will remain available for 1 year.
• Access Criteria: * Qualified researchers affiliated with recognized academic institutions or research organizations with an approved data-sharing request will be able to access the IPD. Researchers may request access to summary findings and non-identifiable data under ethical and institutional guidelines. * They will be able to access de-identified IPD related to outcome measures. * Requests will be reviewed by the principal investigator and an ethics committee based on scientific merit and ethical considerations. Approved researchers must sign a data-sharing agreement outlining data use restrictions. * Data will be shared through a secure repository or institutional data-sharing platform, ensuring compliance with confidentiality and ethical standards.

Locations

PA (1)