Smartphone Use Restriction as Treatment of Primary Headache
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ClinicalTrials.gov Identifier: NCT06041997 |
Recruitment Status :
Recruiting
First Posted : September 18, 2023
Last Update Posted : October 25, 2023
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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)
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Headache Disorders | Behavioral: Smartphone restriction | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Smartphone Use Restriction as Treatment of Primary Headache: a Randomized Controlled Clinical Trial |
Actual Study Start Date : | October 1, 2023 |
Estimated Primary Completion Date : | September 30, 2026 |
Estimated Study Completion Date : | November 30, 2026 |
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. |
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. |
- 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
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041997
Contact: Deepti Vibha | +911126594485 | deeptivibha@aiims.edu | |
Contact: Rajesh Singh | +911126594049 |
India | |
Deepti Vibha | Recruiting |
New Delhi, Delhi, India, 110029 | |
Contact: Deepti Vibha +91-011-26594485 deeptivibha@aiims.edu |
Principal Investigator: | Deepti Vibha | All India Institute of Medical Sciences, New Delhi |
Responsible Party: | Deepti Vibha, Clinical Professor, All India Institute of Medical Sciences, New Delhi |
ClinicalTrials.gov Identifier: | NCT06041997 |
Other Study ID Numbers: |
CSIR-642 |
First Posted: | September 18, 2023 Key Record Dates |
Last Update Posted: | October 25, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized data will be shared on reasonable request |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | After the completion of the publication for six months |
Access Criteria: | Shared on individual request |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Headache Disorders Headache Pain Neurologic Manifestations |
Brain Diseases Central Nervous System Diseases Nervous System Diseases |