- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06041997
Smartphone Use Restriction as Treatment of Primary Headache
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:
- In patients with primary headache, does restriction of smartphone use lead to reduced consumption of medications (acute, prophylaxis, either or both)?
- In patients with primary headache, does restriction of smartphone use lead to better responsiveness to medications (acute, prophylaxis, either or both)?
- Can reduction of smartphone duration be used as a non-pharmacological treatment of primary headache?
- In patients with primary headache, is the type of smartphone use (phone calls, internet browsing, watching screen) determinant of the severity of headache?
- Can we make an addiction score to predict which patient should be advised to limit smartphone use based on the above information?
- 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
Conditions
Intervention / Treatment
Detailed Description
Study description:
Patients/participants:
- 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. 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:
- The frequency of headache over a period of one month, three months after the initiation of study period in the intervention versus control group.
- 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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Deepti Vibha
- Phone Number: +911126594485
- Email: deeptivibha@aiims.edu
Study Contact Backup
- Name: Rajesh Singh
- Phone Number: +911126594049
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110029
- Recruiting
- Deepti Vibha
-
Contact:
- Deepti Vibha
- Phone Number: +91-011-26594485
- Email: deeptivibha@aiims.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 1. Secondary headaches 2. Not consenting for participation or follow up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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
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
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
Collaborators
Investigators
- Principal Investigator: Deepti Vibha, All India Institute of Medical Sciences, New Delhi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSIR-642
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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