Smartphone Use Restriction as Treatment of Primary Headache

November 28, 2024 updated by: Deepti Vibha, All India Institute of Medical Sciences, New Delhi

Smartphone Use Restriction as Treatment of Primary Headache: a Randomized Controlled Clinical 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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study description:

Patients/participants:

  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. Patients will be first asked about their smartphone use.

    • If they do not use smartphone, they will be asked if they use any phone at all for calling, and their call durations will be recorded over the run-in and study period.
    • If they do not use any phone, they will fall in the external control group (Arm A).
    • If the patient uses a feature phone, but not a smartphone, he/she will be in another external control group (Arm B). These patients will not be randomized, but will be maintained on routine follow-up.

    • If they use smartphone their use will be recorded over the study period in terms of:

      o Screen use: Social network/testing/gaming/surfing/reading/music/video

    • The smartphone users may further be classified into low and high smartphone users depending upon the smartphone addiction questionnaire (SAQ): 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 smartphone restriction group (Arm D).

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.

Comparison:

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.

Outcome:

Primary:

The number of times the patient is using acute pain medications for headache per month, within three months after initiation of study period.

Secondary:

  1. The frequency of headache over a period of one month, three months after the initiation of study period in the intervention versus control group.
  2. The number of prophylaxis medications being taken three months after the initiation of study period in the intervention versus control group.

Timeline of measuring outcome:

The follow up will be over a period of 20 weeks after screening eligibility and 16 weeks after randomization. The patient will maintain a headache diary in which he/she will enter the number of times they needed to take rescue medication.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Rajesh Singh
  • Phone Number: +911126594049

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Recruiting
        • Deepti Vibha
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Smartphone restriction

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
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.
No Intervention: Control

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The pill burden for abortive treatment
Time Frame: three months after initiation of study period
The number of times the patient is using acute pain medications for headache in one month
three months after initiation of study period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Headache frequency
Time Frame: One and three months
The frequency of headache over a period of one month, three months after the initiation of study period in the intervention versus control group.
One and three months
Number of prophylactic medication
Time Frame: Three months
The number of prophylaxis medications being taken three months after the initiation of study period in the intervention versus control group.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
All India Institute of Medical Sciences, New Delhi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Council of Scientific and Industrial Research, India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deepti Vibha, All India Institute of Medical Sciences, New Delhi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSIR-642

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be shared on reasonable request

IPD Sharing Time Frame

After the completion of the publication for six months

IPD Sharing Access Criteria

Shared on individual request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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