Primary HeadacheNCT06822673
Impact of MBI on Biopsychosocial Factors and QOL in Children With Primary Headaches
A study testing Mindfulness Based Intervention in people with Primary Headache and Psychological Distress, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Headache, Psychological Distress, Emotion Regulation
- What is being tested?
- Mindfulness Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Mindfulness-Based Intervention on Biopsychosocial Factors Associated With Quality of Life in Children With Primary Headaches: A Randomized Controlled Trial
- 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.
Read the 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
- Being tested
- Mindfulness Based Intervention
- 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
- Medical subject headings
- Emotional Regulation, Sedentary Behavior, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 10-12 weeks
Secondary outcomes (4)
Psychological Distress
- Psychological distress refers to the overall level of emotional discomfort or suffering experienced by an individual. It encompasses symptoms like anxiety, depression, and stress.
- Measurement Tool: Depression Anxiety Stress Scales-Youth version (DASS-Y)
- Unit of Measure: Total and subscale scores for depression, anxiety, and stress, with higher scores indicating greater distress.
- Detail: The scale consists of 21 items, with seven items allocated to each of the three subscales: depression, anxiety, and stress. The overall aggregate score is then calculated to assess the individual's overall level of psychological distress.
Psychological distress will be evaluated to determine the effectiveness of MBI related to emotional distress among children with primary headaches.
Measured: 10-12 weeks
Emotion Regulation
- Emotion regulation refers to the ability to handle emotions effectively. This measure is crucial in assessing how children regulate emotions, particularly in relation to stressful or painful experiences like headaches.
- Measurement Tool: Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
- Unit of Measure: Total score, with higher scores indicating better emotion regulation abilities.
- Detail: This measure assesses children's ability to manage emotions effectively.
Measured: 10-12 weeks
Childhood Traumatic Experiences
- Childhood trauma includes adverse experiences such as abuse, neglect and other traumatic events.
- Measurement Tool: Childhood Trauma Questionnaire-Short Form (CTQ-SF)
- Unit of Measure: Total scores with higher scores indicating greater trauma exposure.
- Detail: The scale assesses the cumulative impact of childhood traumatic experiences. The total score is used to evaluate the relationship between trauma exposure and primary headaches in children.
Measured: 10-12 weeks
Sedentary Behaviors
- Sedentary behaviors involve prolonged inactivity with minimal physical movement.
- Measurement Tool: International Physical Activity Questionnaire (IPAQ) Short Form
- Unit of Measure: Average hours per day spent in sedentary activities.
- Description: The study will assess the effect of MBI on sedentary behaviors.
Measured: 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Jan 2025
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadia Sohail, Fatima Jinnah Women University
- Investigators
- Dr. Iram Gul, PhD, Study chair, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822673
- Sponsor's protocol ID
- FJWU/EC/2024/95
- Other IDs
- FJWU/EC/2024/95
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including primary and secondary outcome measures, excluding personally identifiable information will be shared. IPD that underlie results in a publication will be shared in line with ethical considerations and confidentiality policies.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindfulness-Based Intervention on Biopsychosocial Factors Associated With Quality of Life in Children With Primary Headaches: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06822673
- Acronym / sponsor ID
- FJWU/EC/2024/95
- Conditions
- Primary Headache, Psychological Distress, Emotion Regulation, Childhood Trauma, Sedentary Behaviors, Mindfulness
- Keywords
- Pediatric Primary Headaches, Psychological Distress, Anxiety, Depression, Stress, Emotional Regulation, Childhood Trauma, Sedentary Behavior, Mindfulness-Based Intervention, Quality of Life
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional Group (Receiving Mindfulness Based Intervention) | Experimental | Behavioral: Mindfulness Based InterventionThis 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. |
| 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based InterventionThe 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. | Behavioural | Interventional Group (Receiving Mindfulness Based Intervention) |
Primary outcome
Health-Related Quality-of-Life
Time frame: 10-12 weeks
* 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.
Pediatric Headaches
Time frame: 10-12 weeks
* 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.
Mindfulness
Time frame: 10-12 weeks
* 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.
4 secondary outcomes
Psychological Distress
Time frame: 10-12 weeks
Emotion Regulation
Time frame: 10-12 weeks
Childhood Traumatic Experiences
Time frame: 10-12 weeks
Sedentary Behaviors
Time frame: 10-12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including primary and secondary outcome measures, excluding personally identifiable information will be shared. IPD that underlie results in a publication will be shared in line with ethical considerations and confidentiality policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Iram Gul, PhD study chair
Fatima Jinnah Women University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Intervention in people with Primary Headache and Psychological Distress, run by Fatima Jinnah Women University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality-of-Life (time frame: 10-12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.