An interventional study of Simulation of epinephrine self-injection in Food Allergy, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-07-01.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Supportive care
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.
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 60 is close to the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
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Exclusion Criteria:
The patient will self-inject an empty syringe into his/her thigh simulating a self-injection of epinephrine during a routine outpatient visit to the allergist.
Behavioral: Simulation of epinephrine self-injection
The patient will be encouraged to speak to their physician about self-injection, but will not undergo the self-injection protocol during a routine outpatient visit to the allergist.
Child comfort with epinephrine self-injection
Immediate pre-post differences within the intervention group in the score obtained on a child-reported "comfort with self-injection" questionnaire.
Time frame: Day 1
Child likelihood of epinephrine self-injection
Immediate pre-post differences within the intervention group in the score obtained on a child-reported likelihood of self-injection questionnaire.
Time frame: Day 1
Parent report of child comfort with epinephrine self-injection
Immediate pre-post differences within the intervention group in the score obtained on a parent-reported "child's comfort with self-injection" questionnaire.
Time frame: Day 1
Child comfort with epinephrine self-injection
Immediate post-1 month post differences between groups in the score obtained on a child-reported "comfort with self-injection" questionnaire.
Time frame: 1 month post-intervention
Parent report of child comfort with epinephrine self-injection
Immediate post- 1 month post differences between groups in the score obtained on a parent-reported "child's comfort with self-injection" questionnaire.
Time frame: 1 month post-intervention
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai