Headache DisordersNCT06041997
Smartphone Use Restriction as Treatment of Primary Headache
A study testing Smartphone restriction in people with Headache Disorders, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache Disorders
- What is being tested?
- Smartphone restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 1 Oct 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Secondary headaches 2. Not consenting for participation or follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rajesh Singh contact
India1 site, 1 recruiting
- Recruiting
Deepti Vibha
New Delhi, National Capital Territory of Delhi, 110029
Deepti Vibha, +91-011-26594485, deeptivibha@aiims.edu
About this study
Official title: 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).
Read more
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)
Read the 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:
- 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.
- Conditions
- Headache Disorders
- Being tested
- Smartphone restriction
- Medical subject headings
- Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone restrictionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pill burden for abortive treatment
The number of times the patient is using acute pain medications for headache in one month
Measured: three months after initiation of study period
Secondary outcomes (2)
Headache frequency
The frequency of headache over a period of one month, three months after the initiation of study period in the intervention versus control group.
Measured: One and three months
Number of prophylactic medication
The number of prophylaxis medications being taken three months after the initiation of study period in the intervention versus control group.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Oct 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Council of Scientific and Industrial Research, India
- Responsible party
- Principal investigator, Deepti Vibha, All India Institute of Medical Sciences
- Investigators
- Deepti Vibha, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041997
- Sponsor's protocol ID
- CSIR-642
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2023
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be shared on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Use Restriction as Treatment of Primary Headache: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06041997
- Acronym / sponsor ID
- CSIR-642
- Conditions
- Headache Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Council of Scientific and Industrial Research, India
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone restriction | Experimental | Behavioral: Smartphone restrictionPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Secondary headaches 2. Not consenting for participation or follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone restrictionThe 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. | Behavioural | Smartphone restriction |
Primary outcome
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
2 secondary outcomes
Headache frequency
Time frame: One and three months
Number of prophylactic medication
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Anonymized data will be shared on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Singh contact
Deepti Vibha principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone restriction in people with Headache Disorders, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepti Vibha (+911126594485, deeptivibha@aiims.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pill burden for abortive treatment (time frame: three months after initiation of study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.