Evaluation of Pain Alleviating Strategies During Allergy Shots (Subcutaneous Immunotherapy): A Randomized Controlled Study (Pain Perception With Allergy Shot Techniques: PPAST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Patient Pain Perception Utilizing Three Non-pharmacological Pain Control / Distraction Devices and Ethyl Chloride Spray
研究概览
简要总结
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.
详细描述
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)
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Patient Pain Perception Utilizing Three Non-pharmacological Pain Control / Distraction Devices and Ethyl Chloride Spray
时间窗: 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 (actual faces of happiness or sadness etc. on the scale) Pain Rating Scale (0 no pain - 10 most pain) with each distraction method. The lower score is the better outcome.
次要结局
未报告次要终点
研究者
Jennifer Pfieffer
Pediatric Clinical Nurse Specialist, APRN, and Nurse Manager
Nemours Children's Clinic