Headache, Pain
Conditions
Keywords
self management app, headache, adolescent
Brief summary
The purpose of this study is to test the efficacy of a new app to help adolescents with chronic or reoccurring headaches self manage pain.
Detailed description
Headaches dramatically affect adolescents' overall functioning and quality of life. We have developed a highly engaging mobile-based program that will help adolescents to make connections between behaviors and symptoms, and to ultimately improve functioning and quality of life. The mobile-based program will provide a state of the art pain tracker, a variety of coping strategies, and information about self-management of symptoms. This app will offer a maximally engaging way to help adolescents track their pain, make connections between lifestyle and pain, and learn key self-management skills. The study involves the participant being randomized into either the experimental group, where he/she will be using this mobile application to track their headache symptoms, or the control group, where he/she will receive headache treatment as usual; the control group will not be using an app for this study. The intervention will last for two months. Participants will be assessed at baseline, at 2-months post baseline, at 3-months post baseline, and at 6-months post baseline. All participants will be asked to complete online questionnaires about their headaches. We plan to enroll 144 adolescent participants with headaches, as well as one caregiver (meaning a parent/guardian) for each adolescent.
Interventions
BEHAVIORALpain self management app on smartphone
Sponsors
Stephen F Butler, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
\[The above age limits are specific to adolescent participants.\] Inclusion Criteria - Adolescents * Between ages 13 and 17 (inclusive) * Able to read and speak English * Has recurring headaches that are not related to another medical condition * iPhone user with access to an iPhone \[4/4S or later\] for use during the intervention period
Exclusion criteria
- Adolescents * Secondary headache or seizure disorder. Examples include: increased intracranial pressure, hydrocephalus, traumatic brain injury, benign or cancerous brain * Cognitive impairment or psychiatric condition that would interfere with ability to use the mobile application or complete the assessments Inclusion Criteria - Caregivers Parent or guardian of an adolescent who meets the above eligibility criteria for adolescent participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life at 2 months, 3 months, and 6 months post-baseline | 2 months, 3 months, 6 months | Measured by PedMIDAS - Hershey et al., 2001 |
| Change in pain coping at 2 months, 3 months, and 6 months post-baseline | 2 months, 3 months, 6 months | Measured by Pain Coping Questionnaire (PCQ) - Reid et al., 1998 |
| Change in headache intensity at 2 months, 3 months, and 6 months post-baseline | 2 months, 3 months, 6 months | In the past 7 days, how would you rate your headache pain on average... from 0-no pain to 10-worst possible pain |
| Change in headache frequency at 2 months, 3 months, and 6 months post-baseline | 2 months, 3 months, 6 months | On how many days during the past 30 days have you had a headache? How many days in the past 30 were you completely headache free? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain self-efficacy at 2 months, 3 months, and 6 months post-baseline | 2 months, 3 months, 6 months | Measured by Pain Self-Efficacy Scale - Burch, Tsao, et al., 2006 |
| Change in school absenteeism at 2 months, 3 months, and 6 months post-baseline | 2 months, 3 months, 6 months | Ask caregivers: How many full school days did your child miss in the past 30 days due to headaches? |
| Change in physical and psychosocial functioning at at 2 months, 3 months, and 6 months post-baseline | 2 months, 3 months, 6 months | Measured by parent report version of the PedsQL 4.0 (Varni et al., 1999) |
| Change in health care utilization at 2 months, 3 months, and 6 months post-baseline | 2 months, 3 months, 6 months | Measured by asking caregiver to report information such as the following: * How many days in the past 30 days did his/her child see a healthcare provider for his/her headaches? * What types of treatment (including medications) has his/her child received for headaches in the past 30 days? |
Countries
United States
Outcome results
None listed