NCT06041997 Smartphone Use Restriction as Treatment of Primary Headache
| NCT ID | NCT06041997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | All India Institute of Medical Sciences |
| Condition | Headache Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to study smartphone use restriction as a treatment modality in patients of primary headache. The main question\[s\] it aims to answer are: 1. In patients with primary headache, does restriction of smartphone use lead to reduced consumption of medications (acute, prophylaxis, either or both)? 2. In patients with primary headache, does restriction of smartphone use lead to better responsiveness to medications (acute, prophylaxis, either or both)? 3. Can reduction of smartphone duration be used as a non-pharmacological treatment of primary headache? 4. In patients with primary headache, is the type of smartphone use (phone calls, internet browsing, watching screen) determinant of the severity of headache? 5. Can we make an addiction score to predict which patient should be advised to limit smartphone use based on the above information? 6. In patients with primary headache, does restriction of smartphone use led to improvement in headache severity (frequency, intensity, duration, one of them or all). The smartphone users may further be classified into low and high smartphone users depending upon the smartphone addiction questionnaire (SAQ) (appendix 1) usage score. SUs with 0-1 score on the SAQ were further grouped into low SUs, and patients with score ≥1 were grouped into high SUs. To create a homogenous group, only patients with high SU will be randomized to standard treatment (Arm C) and intervention group (Arm D). Participants will be asked about their smartphone usage, and if found eligible, there will be a run-in period of 4 weeks after which they will be randomized to the intervention (smartphone restriction) or comparison group (no restriction recommended)
Eligibility Criteria
Inclusion Criteria: 1. Patients ≥18 years of age 2. Diagnosis of primary headache as per the ICHD3Beta classification ("ICHD-3 The International Classification of Headache Disorders 3rd Edition" n.d.) 3. Willing and consenting to participate in the study. Exclusion Criteria: * 1\. Secondary headaches 2. Not consenting for participation or follow up
Contact & Investigator
Deepti Vibha
PRINCIPAL INVESTIGATOR
All India Institute of Medical Sciences
Frequently Asked Questions
Who can join the NCT06041997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Headache Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06041997 currently recruiting?
Yes, NCT06041997 is actively recruiting participants. Contact the research team at deeptivibha@aiims.edu for enrollment information.
Where is the NCT06041997 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT06041997 clinical trial?
NCT06041997 is sponsored by All India Institute of Medical Sciences. The principal investigator is Deepti Vibha at All India Institute of Medical Sciences. The trial plans to enroll 60 participants.