Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 338
- 试验地点
- 4
- 主要终点
- Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups.
研究概览
简要总结
This study was a prospective, randomized clinical trial that was conducted in adolescents (10 through 14 years of age) receiving at least one recommended intramuscularly administered vaccine to evaluate the efficacy and acceptability of using two different, simultaneously administered interventions that might prevent post-vaccination presyncope, and by extension syncope. The two interventions evaluated together were Buzzy®, which is a medical device designed to reduce vaccination pain, and an electronic game. The investigators evaluated both interventions when administered simultaneously (Buzzy® and electronic game). The investigators enrolled approximately 340 subjects into this study. Eligible adolescents were randomized (1:1) to either the intervention or control group: 1) intervention (Buzzy® and electronic game); or 2) control (usual care) to assess for acceptability and efficacy. Detailed data were collected and described from study participants including demographics, medical history, baseline generalized and state anxiety, and needle phobia. Participants were observed for 20 minutes following receipt of vaccines and reassessed for post-vaccination state anxiety, immediate and subsequent post-vaccination pain (within 1 minute and at 10 minutes), and the occurrence of witnessed syncope or presyncope, and presyncopal symptoms as rated by the modified Blood Donation Reactions Inventory (BDRI). Participants were asked to assess their acceptability of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10 years through 14 years of age
- •The subject must be receiving at least one vaccine delivered intramuscularly
- •The parent/guardian must be willing and capable of providing written informed consent for the adolescent and the adolescent must be willing and capable of providing assent.
- •The subject must be willing to stay for the completion of all study-related activities.
- •Parent/guardian and adolescent must speak and read English by self-report
- •Parent/guardian must be willing to let their child select an electronic game to play during the study
排除标准
- •Receipt of investigational or experimental vaccine or medication within the previous two weeks
- •Receipt of routine injectable medication
- •Permanent indwelling venous catheter
- •Blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period
- •Injection of medication during the past hour or scheduled for injection of medication during the observation period.
- •Cold intolerance or cold urticaria
- •Raynaud's phenomenon
- •Sickle cell disease
- •Significant visual impairment or blindness
- •Significant auditory impairment or deafness
- •Febrile (>38.0°C) or acutely ill individuals
- •Upper arm or shoulder pain or injury
- •Video game-induced seizures
- •Adolescent or parent/Guardian is an immediate relative of study staff or an employee who is supervised by study staff.
- •Any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
结局指标
主要结局
Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups.
时间窗: Day 1, 20 minutes post vaccination
Subjects were asked to complete a presyncope symptoms assessment (Modified BDRI: Blood Donations Reactions Inventory) at 20 minutes post vaccination. The number of adolescents with presyncope or syncope as determined by the modified BRDR or witnessed presyncope or syncope.
次要结局
- Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at ≤ 1 Minute Following Vaccination.(Day 1, ≤ 1 minute after vaccination)
- Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination.(Day 1, (approximately) 10 minutes following vaccination)
- Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.(Day 1, (approximately) 10 minutes following vaccination)
- Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.(Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes))
- Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety.(Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes))
- Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.(Day 1, (approximately) 10 minutes following vaccination)
- Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.(Day 1, ≤ 1 minute following vaccination)
- Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike(Day 1, approximately 20 minutes post vaccination)
- Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy(Day 1, approximately 20 minutes post vaccination)
- Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.(Day 1, ≤ 1 minute following vaccination)
- Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no(Day 1, approximately 20 minutes post vaccination)
- Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable(Day 1, approximately 20 minutes post vaccination)