Smartphone Use Restriction as Treatment of Primary Headache

• ClinicalTrials.gov Identifier: NCT06041997
• Recruitment Status: Recruiting
• First Posted: September 18, 2023
• Last Update Posted: October 25, 2023
• Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborator: Council of Scientific and Industrial Research, India
• Information provided by (Responsible Party): Deepti Vibha, All India Institute of Medical Sciences, New Delhi

Study Description

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. 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)

Condition or disease	Intervention/treatment	Phase
Headache Disorders	Behavioral: Smartphone restriction	Not Applicable

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Deepti Vibha; +911126594485; deeptivibha@aiims.edu

Contact: Rajesh Singh; +911126594049

Locations

India

Deepti Vibha; Recruiting

New Delhi, Delhi, India, 110029

Contact: Deepti Vibha +91-011-26594485 deeptivibha@aiims.edu

Sponsors and Collaborators

All India Institute of Medical Sciences, New Delhi

Council of Scientific and Industrial Research, India

Investigators

• Principal Investigator: Deepti Vibha; All India Institute of Medical Sciences, New Delhi

More Information

• 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
• 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

Additional relevant MeSH terms:

Headache Disorders; Headache; Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases