About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients ≥18 years of age
Diagnosis of primary headache as per the ICHD3Beta classification ("ICHD-3 The International Classification of Headache Disorders 3rd Edition" n.d.)
Willing and consenting to participate in the study.
Disqualifiers
1. Secondary headaches 2. Not consenting for participation or follow up
Trial design
Parallel
Treatments tested in this trial
Smartphone restriction
BehavioralThe patients will then be advised to cut down the usage by one-third in terms of usage hours. The compliance will be checked at the time of outcome assessment.
Treatment groups
Trial outcomes
Primary outcomes
The pill burden for abortive treatment
The number of times the patient is using acute pain medications for headache in one month
Secondary outcomes
Headache frequency
The frequency of headache over a period of one month, three months after the initiation of study period in the intervention versus control group.
Number of prophylactic medication
The number of prophylaxis medications being taken three months after the initiation of study period in the intervention versus control group.
Sponsors and contacts
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All India Institute of Medical Sciences
Lead sponsor
Council of Scientific and Industrial Research, India
Collaborator