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Smartphone Use Restriction as Treatment of Primary Headache

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study completion pushed from Nov 30, 2026 to Dec 30, 2026
    • Study description expanded, about 10 words
    • Eligibility criteria expanded, about 4 words
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Minor Trial status: Recruiting to Not Yet Recruiting
    • Study description shortened, about 95 words
    • Site details revised
    • Study title shortened, about 5 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06041997
Lead Sponsor All India Institute of Medical Sciences
Collaborators: Council of Scientific and Industrial Research, India
Conditions
(from sponsor)
Headache Disorders
Related terms Headache Disorders
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov