Evaluation of Pain Alleviating Strategies During Allergy Shots
Condition: Immunotherapy; Allergy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Subcutaneous Immunotherapy (allergy injections) is a potentially disease-modifying therapy
      that is effective for the treatment of allergic rhinitis/conjunctivitis, allergic asthma and
      stinging insect hypersensitivity. Pain, which results from the irritation of nearby nerves is
      a common concern of patients, particularly in children, during or after the injections. This
      can be a stressful and negative experience for the children. There are various techniques
      available to minimize pain in general. However, there is a lack of published research on how
      to use these techniques in children receiving allergy injections. The purpose of this study
      is to evaluate and compare the efficacy of the standard of care method (Ethyl Chloride/Pain
      Ease Spray) and three non-pharmacological pain control devices (Buzzy Bee® I, Buzzy Bee II
      and Shot Blocke®r) in decreasing the perception of pain during subcutaneous allergy injection
      in a pediatric allergy/immunology clinic setting.
    

Detailed description: 
      This is a randomized controlled study. Approximately 100 children, age 4 - 17 years, who are
      currently receiving subcutaneous immunotherapy, will randomly select a blinded envelope which
      assigns the distraction technique to be utilized during their study participation. There will
      be 25 envelopes assigned to each study group for a total of 100 envelopes. Each envelope will
      contain a paper with a colored sticker for the associated group assignment and number
      sequence.

      The distribution of group assignment by number sequence and color is as follows:

      Interventional Groups

        1. Shot Blocker® Number 1-25 (RED)

        2. Buzzy I® (vibrating only) Number 26-50 (GREEN)

        3. Buzzy II® (vibrating and ice wings) Number 51-75 (BLUE) Control Group

        4. Ethyl Chloride/Pain Ease Spray Number 76-100 (YELLOW)

      The three interventional groups are currently marketed distraction devices. The control group
      is the current clinical standard of care option for pre-allergy injection application.

      The study consists of two visits. Both visits will be conducted during the participants
      routine clinic visit for allergy injections. At the first visit the investigator will assess
      eligibility. An overview of the study requirements will be provided to parent/child and
      consent/assent will be obtained.

      During the second visit, the child will be randomized to a distraction technique or standard
      of care group to be utilized with the allergy injection(s) administered at this visit.
      Adherence with institutional allergy injection guidelines will be maintained. Prior to the
      application of the distraction method, the investigator will interview the parent to collect
      data related to demographic information and their child's current allergy health and
      treatment regime. The child's pain perception will be assessed before and after the allergy
      injection. The parent's perception of their child's pain will be assessed after the allergy
      injection. The investigator will provide information on the application of the randomized
      method and will provide instruction on the completion of the pain scales and questionnaires.
      The investigator and study staff will not indicate a method preference or guide the child or
      parent with their pain level responses. After completion of the second visit, the child's
      study participation is complete.
    

Intervention name(s): Buzzy Bee with Ice pack; Buzzy Bee without Ice pack; Shot Blocker
Intervention type(s): Device; Device; Device
Intervention description(s): Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used with an ice pack.; Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used without an ice pack.; Shot Blocker is a device that instantly alleviates the pain and anxiety of needle injections when pressed firmly against the skin at the injection site.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study Design and Duration This is a randomized controlled study. Approximately 100 children, age 4 - 17 years, who are currently receiving subcutaneous immunotherapy, will randomly select a blinded envelope which assigns the distraction technique to be utilized during their study participation. There will be 25 envelopes assigned to each study group for a total of 100 envelopes. Each envelope will contain a paper with a colored sticker for the associated group assignment and number sequence.
The distribution of group assignment by number sequence and color is as follows:
Interventional Groups
Shot Blocker® Number 1-25 (RED)
Buzzy I® (vibrating only) Number 26-50 (GREEN)
Buzzy II® (vibrating and ice wings) Number 51-75 (BLUE)
Control Group Ethyl Chloride/Pain Ease Spray Number 76-100 (YELLOW)
Masking: None (Open Label)
Primary purpose: Other