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Audio Hypnosis for Reducing Anxiety in Children and Adolescents Undergoing MRI: A Randomized Controlled Trial

ConditionsHypnosisAnxiety, Preoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorUniversity of Witten/Herdecke

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 6 and 14 years

Planned MRI examination without anesthesia

Subjects should have a good understanding of the German language

Disqualifiers

Severe cognitive impairment or mental retardation

Severely limiting psychiatric disorders

Addictive disorders

Limited understanding of the German language

Trial design

Design model

Parallel

Treatments tested in this trial

  • Audio hypnosis

    Other intervention

    Audio hypnosis via a digital recording ("Ellis Traumgeschichte") accessible via QR code

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: hypnosis groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

anxiety prosective

Self-reported anxiety assessment using the KAT III questionnaire

Time frame
directly before the MRI

Secondary outcomes

1

Anxiety External assessment by parents

Anxiety External assessment by parents (Visual Analog Scale (VAS)

Time frame
directly before the MRI
2

MRI Interruption frequency, Cancellation, Motion artifacts

MRI Interruption frequency, Cancellation, Motion artifacts on MRI images by MRI technologists

Time frame
during MRI
3

Anxiety external assessment by MRI technologist

Anxiety external assessment by MRI technologist using VAS (visual analog scale)

Time frame
directly after MRI
4

Anxiety retrospective

Retrospective self-reported anxiety assessment using KAT III questionnaire

Time frame
directly after MRI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Witten/Herdecke

Lead sponsor

Source ClinicalTrials.gov
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