Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues
NCT ID: NCT07157358
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
345 participants
INTERVENTIONAL
2025-07-31
2026-09-01
Brief Summary
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The main questions it aims to answer are:
1. can daily listening to these exercsies improve self-esteem, resilience and mental health of children 10-11 years compared to children who do not listen to these exercises?
2. can listening to these exercsies prevent future metal health problems like feelings of depression or anxiety.
Researchers will compare a group of children (10-11 years) who will listen daily to the exercises for 2 months with a group who will do that 6 months later.
Participants will:
Listen daily to a hypnosis exercise of maximum 15 minutes. Fill out questionnaires on self-esteem, resilience and mental health before during and after the study.
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Detailed Description
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Rationale:
Early adolescence marks a crucial period for the development and onset of mental health problems, which often manifest as disorders in the course of adulthood if they are not dealt with early on. Moreover, there is an increased prevalence of disorders like anxiety and depression in adolescence. Prevention of these mental health problems is of great importance.
Objective: The primary objective is to study the effect of daily listening for 6 weeks to the Breinbaas hypnosis recordings on selfesteem compared to controls. Secondary objective(s) are studying the effect of daily listening to the Breinbaas hypnosis recordings for 6 weeks on change in resilience, psychosocial functioning, overall stress level, and other effects like sleep compared to controls. Study design: This is a randomized controlled open-label study with a duration of six months. Children will be randomized to start immediately with the online program (Group A) or after 6 months (group B). Group B will therefore be the control group of A.
Study population: Children from grade 6 or 7 of the participating primary schools will be invited to participate. Schools will be recruited in 3 areas in the Netherlands.
Intervention: The online Breinbaas academy program consists of hypnosis audio recordings that children will listen to on every schoolday for six weeks. The hypnosis audio recordings aim to improve children's mental health.
Main study parameters/endpoints: Children fill out questionnaires at baseline, 6 weeks and 6 months about the child's self-esteem, psychosocial functioning, resilience, stress levels, and sleep.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group A
Childnre in group A will listen daily for 6 weeks to different hypnosis recordings aiming at the increase of self-esteem, resilience, and mental health in general.
standardized audio hypnosis recordings for healthy children at primary school
8 different audio hypnosis recordings hat chidlren will listen too at a daily basis (one recording per day)
Group B
These children will start listening to the exercises after 6 months, which is already the end of the study. Therefor, their scores in the first 6 months are the controls to group A.
No interventions assigned to this group
Interventions
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standardized audio hypnosis recordings for healthy children at primary school
8 different audio hypnosis recordings hat chidlren will listen too at a daily basis (one recording per day)
Eligibility Criteria
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Inclusion Criteria
2. Attending group 6 or 7 of a regular primary school in the Netherlands
3. Permission of the parents to listen daily to one of the Breinbaas hypnosis exercises (maximum 20 minutes per day)
4. Access to an electronic device to listen to the Breinbaas exercises (phone, tablet, computer) -
Exclusion Criteria
1. Children treated with hypnotherapy in the three years preceding potential inclusion
2. Children currently receiving psychological treatment
9 Years
12 Years
ALL
Yes
Sponsors
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Leiden University
OTHER
St. Antonius Hospital
OTHER
Responsible Party
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Arine Vlieger
Pediatrician, MD, PhD
Principal Investigators
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Arine M Vlieger, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius Hospital
Locations
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University Leiden
Leiden, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Rutten JMTM, Vlieger AM, Frankenhuis C, George EK, Groeneweg M, Norbruis OF, Tjon A Ten W, van Wering HM, Dijkgraaf MGW, Merkus MP, Benninga MA. Home-Based Hypnotherapy Self-exercises vs Individual Hypnotherapy With a Therapist for Treatment of Pediatric Irritable Bowel Syndrome, Functional Abdominal Pain, or Functional Abdominal Pain Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2017 May 1;171(5):470-477. doi: 10.1001/jamapediatrics.2017.0091.
Related Links
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This Dutch website gives information on the hypnosis exercises used in this study
Other Identifiers
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NL 87558.100.24
Identifier Type: -
Identifier Source: org_study_id
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