Effectiveness of an Audio-hypnosis Intervention on Pre-interventional Anxiety During an MRI Examination in Children and Adolescents: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- anxiety prosective
研究概览
简要总结
The goal of this clinical trial is to find out if listening to an audio hypnosis recording can help reduce anxiety in children and adolescents (ages 6-14) who are getting an MRI scan without sedation. The main questions the study will answer are:
Does listening to a hypnosis audio before an MRI help children feel less anxious? Can hypnosis audio help reduce scan interruptions or early terminations?
To find out, researchers will compare one group of children who listen to the hypnosis audio with another group who receive the usual explanation from medical staff to see if the audio helps lower anxiety and makes the MRI process smoother.
What participants will do:
Be randomly placed into either the hypnosis group (who get access to the hypnosis audio) or the control group (who receive the usual explanation).
Listen to the hypnosis audio as many times as they like before the MRI (if in the hypnosis group).
Fill out questionnaires before and after the MRI to measure anxiety (both children and parents).
Have their MRI scan while researchers track any interruptions or early terminations.
Have their anxiety levels rated by MRI technologists after the scan.
This study aims to see if a simple, non-medication method like audio hypnosis can help children feel calmer during MRI exams.
详细描述
Study Overview This is a randomized controlled trial (RCT) investigating the effectiveness of an audio hypnosis intervention in reducing pre-procedural anxiety in children and adolescents (ages 6-14) undergoing an MRI examination without sedation. The study will compare an intervention group (receiving access to an audio hypnosis recording) with a control group (receiving standard pre-MRI explanations) to assess whether the hypnosis audio reduces anxiety levels, improves patient cooperation, and minimizes scan interruptions or movement artifacts.
The study is monocentric, conducted at the Elisabeth Hospital Essen, Department of Pediatric Medicine, and aims to enroll 100 participants (50 per group).
Study Design
- Type: Randomized, controlled, single-center interventional study
- Intervention: Audio hypnosis via a digital recording ("Ellis Traumgeschichte") accessible via QR code
- Control: Standard pre-MRI information provided by medical staff
- Sample Size: 100 participants (50 per group)
- Study Duration: Recruitment period of up to 24 months, with the total study duration extending until data analysis is complete
- Intervention Duration: The hypnosis audio lasts approximately 20 minutes and can be listened to multiple times before the MRI scan Intervention and Data Collection
Participants will be randomly assigned to one of two groups:
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
- Double (Care Provider, Investigator)
盲法说明
the MRI technologists are blinded outcome assessors
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 14 years
- •Planned MRI examination without anesthesia
- •Subjects should have a good understanding of the German language
排除标准
- •Severe cognitive impairment or mental retardation
- •Severely limiting psychiatric disorders
- •Addictive disorders
- •Limited understanding of the German language
- •Taking sedative medication (e.g. lorazepam)
研究组 & 干预措施
hypnosis group
listen to an audio hypnosis via a digital recording ("Elli's dream story"), which is accessible via a QR code, before the MRI examination
干预措施: Audio hypnosis (Other)
Control group
Standard pre-MRI information provided by medical staff
结局指标
主要结局
anxiety prosective
时间窗: directly before the MRI
Self-reported anxiety assessment using the KAT III questionnaire
次要结局
- Anxiety External assessment by parents(directly before the MRI)
- MRI Interruption frequency, Cancellation, Motion artifacts(during MRI)
- Anxiety external assessment by MRI technologist(directly after MRI)
- Anxiety retrospective(directly after MRI)