Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
研究概览
简要总结
This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 years through 17 years of age
- •If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly
- •If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be 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
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
- •Inability to hear
- •Significant visual impairment or blindness
- •Febrile or acutely ill individuals
- •Upper arm or shoulder pain or injury
- •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
研究组 & 干预措施
Buzzy®
Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.
干预措施: Buzzy® (Device)
Music
Music will be selected and listened to as a distraction before and during vaccination.
干预措施: Music (Behavioral)
Buzzy® and Music
Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.
干预措施: Buzzy® (Device)
Buzzy® and Music
Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.
干预措施: Music (Behavioral)
结局指标
主要结局
Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
时间窗: Day1
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
时间窗: Day1
Music will be played over speakers through the 10 minute post vaccination pain assessment
Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
时间窗: Day1
Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.
Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
时间窗: Day1
Music will be played over speakers for a minimum of 3 minutes prior to vaccination
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
时间窗: Day1
Subjects will complete a post vaccination pain assessment within one minute of their final vaccination
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
时间窗: Day1
Subjects will complete a post vaccination anxiety assessment
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
时间窗: Day1
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
时间窗: Day1
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
时间窗: Day1
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
时间窗: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
时间窗: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
时间窗: Day1
Subjects will be asked to complete an anxiety assessment prior to vaccination
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
时间窗: Day1
Subjects will be asked to complete a needle phobia assessment pre-vaccination
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
时间窗: Day1
Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination
Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
时间窗: Day1
Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Number of Subjects Who Complete the Acceptability Assessment
时间窗: Day1
Subjects will be given a questionnaire about the acceptability of their intervention.
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
时间窗: Day1
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
时间窗: Day1
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
时间窗: Day1
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
时间窗: Day1
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
时间窗: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
时间窗: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
时间窗: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s
时间窗: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
时间窗: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
时间窗: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s
时间窗: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
时间窗: Day1
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
时间窗: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
时间窗: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
时间窗: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
次要结局
未报告次要终点