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临床试验/ACTRN12615000867594
ACTRN12615000867594已完成未知

In adolescents, does using biofeedback mediated relaxation techniques during vaccination, compared to standard vaccination process, reduce fear, pain and anxiety associated with school-based vaccination.

Princess Margaret Hospital0 个研究点目标入组 182 人开始时间: 2015年8月20日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
182

研究概览

简要总结

This study aimed to reduce pain, fear and anxiety associated with school-based vaccination by using an iPad ‘app’ called Brighthearts. The BrightHearts app was developed at the Children’s Hospital at Westmead, NSW, for teaching children relaxation techniques to deal with pain. Year 8 students participated in the study from October 2015 to March 2016, during their school’s scheduled vaccination day. Only those students whose parents had given written consent were eligible to take part. Participating students were randomly allocated to use the BrightHearts app while receiving their vaccinations or to follow usual vaccination procedure (i.e. not using an iPad ‘app’ while being vaccinated). Both groups completed a questionnaire after they had been vaccinated. 176 students from three Perth schools completed the study. Overall we found that there was no difference in the levels of pain, fear and anxiety that were reported by the two different groups. However, 60% of the students that used the BrightHearts app said that it helped them during their vaccinations and 73% would like to use it again. We also conducted six interviews with members of the immunisation team, school health nurses and school teachers who were involved in the vaccination days. Almost all reported that they had noticed that the students using the BrightHearts app were more focused and less concerned about their vaccinations. They were supportive of the app being used to help students with their vaccinations.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention

入排标准

年龄范围
12 Years 至 14 Years(—)
性别
All

入选标准

  • 1.The school is co-educational, located in the Perth metropolitan area, has greater than or equal to 100 students enrolled in year 8 and is participating in the school-based immunisation program.
  • 2.The Principal has given informed consent for the school to participate in the study.
  • 1.The participant is enrolled in Year 8 at a school that is participating in the study.
  • 2.The participant is being vaccinated at school as part of the school-based immunisation program.
  • 3.The participant has parent/guardian consent and has also given their assent to participate in the study.
  • 4.The participant is willing and able to comply with using the BrightHearts app.
  • 5.The participant is capable of reading and completing the student questionnaire.
  • Immunisation nurses:
  • 1.The participant is a nurse who has conducted the school-based immunisation program on the same day that students participated in the study.
  • 2.The participant has given informed consent.
  • 3.The participant is willing and able to participate in an interview.
  • School personnel:
  • 1.The participant is employed at a school participating in the study (including school health nurses, teachers and student support staff) and has provided student supervision on the vaccination day during which students completed the study.
  • 2.The participant has given informed consent.
  • 3.The participant is willing and able to participate in an interview.

排除标准

  • 1.The participant is not receiving any vaccinations at school as part of the school-based immunisation program.
  • 2.English language literacy has been identified as insufficient to complete the questionnaire.

研究者

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