Actively Recruiting
Effectiveness of an Audio-hypnosis Intervention on Pre-interventional Anxiety During an MRI Examination in Children and Adolescents: a Randomized Controlled Trial
Led by University of Witten/Herdecke · Updated on 2025-03-21
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether listening to an audio hypnosis recording can reduce anxiety in children and adolescents aged 6 to 14 during MRI scans without sedation. This randomized controlled trial compares the hypnosis audio intervention with the usual explanations given by medical staff to see if it lowers anxiety and reduces scan interruptions or early terminations. The study is conducted at a single center and aims to enroll 100 participants. Participants are randomly assigned to either the hypnosis group, who receive access to a 20-minute hypnosis audio recording via a QR code and may listen to it multiple times before their MRI, or the control group, who receive standard verbal and written pre-MRI information. Both groups undergo their scheduled MRI scan without sedation. The study includes a recruitment period of up to 24 months with ongoing data analysis. During the study, participants complete anxiety questionnaires before and after the MRI, with input from both children and parents. Researchers track scan interruptions, early terminations, and motion artifacts during the MRI. Anxiety levels are also rated by MRI technologists after the scan. The study follows strict data quality controls, monitors safety, and aims to assess if audio hypnosis is a simple, non-medication method to help children feel calmer during MRI exams.
CONDITIONS
Brief Title
Audio Hypnosis for Reducing Anxiety in Children and Adolescents Undergoing MRI: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 14 years
- Planned MRI examination without anesthesia
- Good understanding of the German language
You will not qualify if you...
- Severe cognitive impairment or mental retardation
- Severely limiting psychiatric disorders
- Addictive disorders
- Limited understanding of the German language
- Taking sedative medication (e.g. lorazepam)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for enrollment and consent
Duration - Up to a few hours on the day of the MRI
Participants listen to an audio hypnosis recording or receive standard pre-MRI information before their MRI scan to reduce anxiety.
1 baseline visit (in-person) including randomization and intervention delivery, followed by the MRI scan visit
Duration - Same day as MRI scan
Participants complete anxiety assessments before and after the MRI scan, and MRI scan quality is evaluated.
1 follow-up visit (in-person) immediately before and after the MRI
Trial Site Locations
Total: 1 location
1
Elisabeth Hospital
Essen, Germany, 45138
Actively Recruiting
Research Team
M
Melanie Anheyer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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