Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues (Breinbaas)

St. Antonius Hospital

Status: Enrolling

Conditions: Healty Volunteers

Treatments: Behavioral: standardized audio hypnosis recordings for healthy children at primary school

Study type: Interventional

Funder types: Other

Identifiers

NCT07157358

NL 87558.100.24

Details and patient eligibility

About

The goal of this trial is to learn if listening daily to online hypnosis exercises helps to improve mental health and self-esteem in primary school children. In the future we also hope to see if it can prevent feelings of depession or anxiety when these children have become teenagers.

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.

Full description

SUMMARY

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.

Enrollment: 345 estimated patients

Sex: All

Ages: 9 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:

1. Fluent in Dutch
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:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

1. Children treated with hypnotherapy in the three years preceding potential inclusion
2. Children currently receiving psychological treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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345 participants in 2 patient groups

Group A

Experimental group

Description:

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.

Treatment:

Behavioral: standardized audio hypnosis recordings for healthy children at primary school

Group B

No Intervention group

Description:

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.