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CTRI Number  CTRI/2026/02/103481 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of guided mindfulness meditation on sensory sensitivity and thinking abilities in people with migraine, irritable bowel syndrome, and fibromyalgia 
Scientific Title of Study   Assessment of the effect of guided mindfulness meditation on sensory hypersensitivity and cognitive function in patients with migraine, irritable bowel syndrome, and fibromyalgia: a randomized controlled study with extended follow-up 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujata Roshan 
Designation  Professor, Department of Neurology 
Affiliation  Govind Ballabh Pant Hospital, Delhi 
Address  Department of Neurology, Govind Ballabh Pant Hospital, Delhi

Central
DELHI
110002
India 
Phone  8447761433  
Fax    
Email  drsujataroshan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manvi Lamba 
Designation  Student 
Affiliation  Maulana Azad Medical College, Delhi 
Address  Department of Neurology Govind Ballabh Pant Institute of Postgraduate Medical Education & Research (G.B. Pant Hospital) Jawaharlal Nehru Marg New Delhi – 110002 India

Central
DELHI
110002
India 
Phone  9205977668  
Fax    
Email  manvilamba234@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manvi Lamba 
Designation  Student 
Affiliation  Maulana Azad Medical College, Delhi 
Address  Department of Neurology Govind Ballabh Pant Institute of Postgraduate Medical Education & Research (G.B. Pant Hospital) Jawaharlal Nehru Marg New Delhi – 110002 India

Central
DELHI
110002
India 
Phone  9205977668  
Fax    
Email  manvilamba234@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  G B Pant Institute of Postgraduate Medical Education and Research 
Address  Govind Ballabh Pant Institute of Postgraduate Medical Education & Research G.B. Pant Hospital Campus Jawaharlal Nehru Marg New Delhi – 110002 Delhi India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manvi Lamba  G B Pant Institute of Postgraduate Medical Education and Research  Neurology OPD room no. 327 Department of Neurology G.B. Pant Hospital Jawaharlal Nehru Marg New Delhi – 110002 India
Central
DELHI 		 9205977668

manvilamba234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Behavioural  Participants in the control arm will receive standard medical care without guided mindfulness intervention during the study period. 
Intervention  Meditation group  Participants in the intervention arm will undergo guided mindfulness meditation sessions of 20 minutes duration, five times per week, for a total period of 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults aged eighteen to fifty five years diagnosed with migraine as per International Classification of Headache Disorders criteria, with comorbid irritable bowel syndrome and fibromyalgia, willing to provide informed consent and comply with study procedures. 
 
ExclusionCriteria 
Details  Secondary headache disorders, severe psychiatric illness, cognitive impairment interfering with assessment, pregnancy or lactation, concurrent participation in another interventional study, or inability to comply with the intervention protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in sensory hypersensitivity and cognitive function scores from baseline to post intervention.  Baseline, six weeks and twelve weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in migraine related disability and symptom severity scores.  Baseline, six weeks and twelve weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective randomized controlled study designed to evaluate the effect of guided mindfulness meditation on sensory hypersensitivity and cognitive function in patients diagnosed with migraine with comorbid irritable bowel syndrome and fibromyalgia. Eligible participants aged 18 to 80 years will be randomly allocated to either a guided mindfulness meditation intervention group or a control group receiving standard care. The intervention group will undergo structured mindfulness meditation sessions for a predefined duration, while the control group will continue routine clinical management. Outcome measures will include changes in sensory hypersensitivity scores and cognitive function assessed at baseline and predefined follow up intervals. Secondary outcomes will include headache related disability and quality of life measures. The study aims to assess the feasibility and effectiveness of mindfulness based intervention as an adjunctive non pharmacological therapy in this patient population. 
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