Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06041997

Smartphone Use Restriction as Treatment of Primary Headache

Led by All India Institute of Medical Sciences · Updated on 2024-12-02

60

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

A

All India Institute of Medical Sciences

Lead Sponsor

C

Council of Scientific and Industrial Research, India

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

Smartphone Use Restriction as Treatment of Primary Headache

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years of age or older
  • Diagnosis of primary headache based on the ICHD3Beta classification
  • Willing and consenting to participate in the study
Not Eligible

You will not qualify if you...

  • Secondary headaches
  • Not consenting to participate or follow up

AI-Screening

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Trial Site Locations

Total: 1 location

1

Deepti Vibha

New Delhi, National Capital Territory of Delhi, India, 110029

Actively Recruiting

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Research Team

D

Deepti Vibha

CONTACT

R

Rajesh Singh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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