Self-injection and Self-management
| Status: | Completed |
|---|---|
| Conditions: | Allergy, Allergy, Food Studies |
| Therapuetic Areas: | Otolaryngology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 13 - 17 |
| Updated: | 7/2/2016 |
| Start Date: | March 2015 |
| End Date: | June 2016 |
Epinephrine Self-injection and Self-management of Food Allergies
The purpose of the present study is to determine if asking adolescent patients (ages 13-17)
to self-inject an empty syringe into their thigh during routine clinic visits results in
increased reported comfort with self-injection, reduced anxiety regarding self-injection and
food allergy management for both patient and caregiver(s), and in greater perceived
likelihood of epinephrine self-injection, in the event of an emergency.
to self-inject an empty syringe into their thigh during routine clinic visits results in
increased reported comfort with self-injection, reduced anxiety regarding self-injection and
food allergy management for both patient and caregiver(s), and in greater perceived
likelihood of epinephrine self-injection, in the event of an emergency.
The purpose of the present study is to determine if asking adolescent patients (ages 13-17)
to self-inject an empty syringe into their thigh during routine clinic visits results in
increased reported comfort with self-injection, reduced anxiety regarding self-injection and
food allergy management for both patient and caregiver(s), and in greater perceived
likelihood of epinephrine self-injection, in the event of an emergency. Forty participants,
in total, will be recruited during routine visits to an outpatient allergy clinic. Half of
all participants will be randomized to the behavioral self-management intervention; whereby
patients will insert a needle attached to an empty syringe into their thigh (simulating an
injection of epinephrine); the other half of participants will be randomized to the control
condition, and will be encouraged to speak to their physician about self-injection, but will
not undergo the self-injection protocol. Prior to randomization, baseline measures will be
collected on patient's comfort with epinephrine self-injection. Following the self-injection
protocol and/or the discussion of self-injection with the physician, all participants will
complete immediate post-intervention questionnaires at clinic about comfort with
self-injection, health care management and anxiety. One month following the clinic visit,
all patients will be sent a follow-up questionnaire that will include items identical to the
ones completed at immediate post-intervention.
to self-inject an empty syringe into their thigh during routine clinic visits results in
increased reported comfort with self-injection, reduced anxiety regarding self-injection and
food allergy management for both patient and caregiver(s), and in greater perceived
likelihood of epinephrine self-injection, in the event of an emergency. Forty participants,
in total, will be recruited during routine visits to an outpatient allergy clinic. Half of
all participants will be randomized to the behavioral self-management intervention; whereby
patients will insert a needle attached to an empty syringe into their thigh (simulating an
injection of epinephrine); the other half of participants will be randomized to the control
condition, and will be encouraged to speak to their physician about self-injection, but will
not undergo the self-injection protocol. Prior to randomization, baseline measures will be
collected on patient's comfort with epinephrine self-injection. Following the self-injection
protocol and/or the discussion of self-injection with the physician, all participants will
complete immediate post-intervention questionnaires at clinic about comfort with
self-injection, health care management and anxiety. One month following the clinic visit,
all patients will be sent a follow-up questionnaire that will include items identical to the
ones completed at immediate post-intervention.
Inclusion Criteria:
- Patients seen in the outpatient clinic and their caretakers (no inpatients).
- Patients must have been diagnosed with food allergy and previously prescribed
self-injectable epinephrine.
- Patients between the ages of 13-17 years old.
- Parent consent and child assent.
Exclusion Criteria:
- Patients and caregiver(s) who have been diagnosed with cognitive barriers that
prevent them from understanding the study, as determined by either: a previously
diagnosed mental retardation or inability to repeat the study protocol at the time of
consent.
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