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Clinical Trials in India / NCT06041997
Recruiting Not applicable

Smartphone Use Restriction as Treatment of Primary Headache

NCT06041997 · tracked via the Priya Life Science India tracker
Sponsor
All India Institute of Medical Sciences
Phase
Not applicable
Started
2023-10-01
Last updated
2024-12-02

Condition(s) studied

Headache Disorders

Investigational drug(s) / intervention(s)

Smartphone restriction

Smartphone restriction: The 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Deepti Vibha New Delhi National Capital Territory of Delhi Recruiting

More All India Institute of Medical Sciences trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06041997 on ClinicalTrials.gov ↗ ← All trials in India