Smartphone Use Restriction as Treatment of Primary Headache

NCT06041997 | Recruiting DMC

• 1 other identifier: CSIR-642
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.In patients with primary headache, does restriction of smartphone use lead to reduced consumption of medications (acute, prophylaxis, either or both)?
2. 2.In patients with primary headache, does restriction of smartphone use lead to better responsiveness to medications (acute, prophylaxis, either or both)?
3. 3.Can reduction of smartphone duration be used as a non-pharmacological treatment of primary headache?
4. 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. 5.Can we make an addiction score to predict which patient should be advised to limit smartphone use based on the above information?
6. 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).

Conditions

Headache Disorders

Outcome Measures

Primary Outcomes (1)

• The pill burden for abortive treatment

  The number of times the patient is using acute pain medications for headache in one month

  three months after initiation of study period

Secondary Outcomes (2)

• Headache frequency

  One and three months

• Number of prophylactic medication

  Three months

Study Arms (2)

Smartphone restriction

EXPERIMENTAL

Patients with headache with history of high smartphone use will be randomized into restriction and no-restriction arm. Restriction method: In the 'run-in' period of four weeks, the smartphone usage will be assessed in terms of number of overall use. 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.

Behavioral: Smartphone restriction

Control

NO INTERVENTION

Comparison: In the 'run-in' period of four weeks, the smartphone usage will be assessed in terms of number of overall use. In the non-intervention group only the smartphone usage data will be collected in the study period. The non-smartphone users will be as another control arm.

Interventions

Smartphone restriction BEHAVIORAL

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.

Smartphone restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Secondary headaches 2. Not consenting for participation or follow up

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Council of Scientific and Industrial Research, India: collaborator

Study Sites (1)

Deepti Vibha

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

RECRUITING

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Deepti Vibha

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepti Vibha

CONTACT

+911126594485; deeptivibha@aiims.edu

Rajesh Singh

CONTACT

+911126594049

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 18, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the completion of the publication for six months
• Access Criteria: Shared on individual request

Locations

IN (1)