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Evaluation of Pain Alleviating Strategies During Allergy Shots (PPAST)

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ClinicalTrials.gov Identifier: NCT04181632
Recruitment Status : Suspended (Due to the pandemic, enrollment was halted and patients were not coming to clinic. 40 of 100 patients were randomized.)
First Posted : November 29, 2019
Last Update Posted : January 25, 2021
Sponsor:
Information provided by (Responsible Party):
Jennifer Pfieffer, Nemours Children's Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Immunotherapy Allergy Device: Buzzy Bee with Ice pack Device: Buzzy Bee without Ice pack Device: Shot Blocker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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

  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)
  4. Control Group Ethyl Chloride/Pain Ease Spray Number 76-100 (YELLOW)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Pain Alleviating Strategies During Allergy Shots (Subcutaneous Immunotherapy): A Randomized Controlled Study (Pain Perception With Allergy Shot Techniques: PPAST)
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : November 30, 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Shot Blocker
The three interventional groups are currently marketed distraction devices. Arm 1 will be Shot Blocker® Number 1-25 (RED).
Device: Shot Blocker
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.

No Intervention: Control Group
The control group is the current clinical standard of care option for pre-allergy injection application. Ethyl Chloride/Pain Ease Spray Number 76-100 (YELLOW).
Active Comparator: Buzzy I
The three interventional groups are currently marketed distraction devices. Arm 2 will be Buzzy® I (vibrating only) Number 26-50 (GREEN).
Device: Buzzy Bee without 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.

Active Comparator: Buzzy II
The three interventional groups are currently marketed distraction devices. Arm 3 will be Buzzy® II (vibrating and ice wings) Number 51-75 (BLUE).
Device: Buzzy Bee with Ice pack
Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used with an ice pack.




Primary Outcome Measures :
  1. Change in patient pain perception utilizing three non-pharmacological pain control / distraction devices and Ethyl Chloride spray [ Time Frame: Assessment of pain perception before and within 1 minute after the application of the distraction method and administration of the allergy injection within their 30-minute allergy shot appointment. ]
    The change in patient pain perception will be captured utilizing the Wong-Baker FACES Pain Rating Scale (0 no pain - 10 most pain) with each distraction method.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 4-17 years on injection immunotherapy
  • A minimum of three allergy injection injections prior to enrollment at Visit 1
  • Child accompanied by parent or legal guardian

Exclusion Criteria:

  • Children with a known pain or sensory disorders
  • Developmental delays lacking necessary cognitive ability
  • Administration of any form of pain analgesic within eight hours of randomization at Visit 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181632


Locations
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United States, Florida
Nemours
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
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Responsible Party: Jennifer Pfieffer, Pediatric Clinical Nurse Specialist, APRN, and Nurse Manager, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT04181632    
Other Study ID Numbers: 1353562
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases