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

NCT06866457 | Recruiting

• 1 other identifier: 260/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypnosis; Anxiety, Preoperative

Keywords

MRI Anxiety in Children; Hypnosis in Pediatric Medicine; hypnosis; hypnosis MRI

Outcome Measures

Primary Outcomes (1)

• anxiety prosective

  Self-reported anxiety assessment using the KAT III questionnaire

  directly before the MRI

Secondary Outcomes (4)

• 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

Study Arms (2)

hypnosis group

EXPERIMENTAL

listen to an audio hypnosis via a digital recording ("Elli's dream story"), which is accessible via a QR code, before the MRI examination

Other: Audio hypnosis

Control group

NO INTERVENTION

Standard pre-MRI information provided by medical staff

Interventions

Audio hypnosis OTHER

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

hypnosis group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 6 and 14 years
• Planned MRI examination without anesthesia
• Subjects should have a good understanding of the German language

You may not qualify if:

• Severe cognitive impairment or mental retardation
• Severely limiting psychiatric disorders
• Addictive disorders
• Limited understanding of the German language
• Taking sedative medication (e.g. lorazepam)

Sponsors & Collaborators

• University of Witten/Herdecke: lead

Study Sites (1)

Elisabeth Hospital

Essen, 45138, Germany

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Melanie Anheyer

CONTACT

004920189786627; m.anheyer@contilia.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: the MRI technologists are blinded outcome assessors
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): March 10, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

DE (1)