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Smartphone Use Restriction as Treatment of Primary Headache

Primary Purpose

Headache Disorders

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Smartphone restriction
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deepti VibhaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smartphone restriction

Control

Arm Description

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 '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.

Outcomes

Primary Outcome Measures

The pill burden for abortive treatment
The number of times the patient is using acute pain medications for headache in one month

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 12, 2023
Last Updated
October 24, 2023
Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborators
Council of Scientific and Industrial Research, India
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1. Study Identification

Unique Protocol Identification Number
NCT06041997
Brief Title
Smartphone Use Restriction as Treatment of Primary Headache
Official Title
Smartphone Use Restriction as Treatment of Primary Headache: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborators
Council of Scientific and Industrial Research, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone restriction
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone restriction
Intervention Description
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.
Primary Outcome Measure Information:
Title
The pill burden for abortive treatment
Description
The number of times the patient is using acute pain medications for headache in one month
Time Frame
three months after initiation of study period
Secondary Outcome Measure Information:
Title
Headache frequency
Description
The frequency of headache over a period of one month, three months after the initiation of study period in the intervention versus control group.
Time Frame
One and three months
Title
Number of prophylactic medication
Description
The number of prophylaxis medications being taken three months after the initiation of study period in the intervention versus control group.
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deepti Vibha
Phone
+911126594485
Email
deeptivibha@aiims.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rajesh Singh
Phone
+911126594049
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepti Vibha
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deepti Vibha
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepti Vibha
Phone
+91-011-26594485
Email
deeptivibha@aiims.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Smartphone Use Restriction as Treatment of Primary Headache

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