Clinical trial NCT06822673: Impact of MBI on Biopsychosocial Factors and QOL in Children With Primary Headaches
Official title: Impact of Mindfulness-Based Intervention on Biopsychosocial Factors Associated With Quality of Life in Children With Primary Headaches: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Health-Related Quality-of-Life
timeFrame: 10-12 weeks
measure: Pediatric Headaches
timeFrame: 10-12 weeks
measure: Mindfulness
timeFrame: 10-12 weeks
Secondary outcomes:
measure: Psychological Distress
timeFrame: 10-12 weeks
measure: Emotion Regulation
timeFrame: 10-12 weeks
measure: Childhood Traumatic Experiences
timeFrame: 10-12 weeks
measure: Sedentary Behaviors
timeFrame: 10-12 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fatima Jinnah Women University
Study officials:
affiliation: Fatima Jinnah Women University
name: Dr. Iram Gul, PhD
role: STUDY_CHAIR
References: