Healty VolunteersBreinbaasNCT07157358
Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues
A study testing standardized audio hypnosis recordings for healthy children at primary school in people with Healty Volunteers, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healty Volunteers
- What is being tested?
- standardized audio hypnosis recordings for healthy children at primary school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteNetherlands
- Study dates
- 31 Jul 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Children treated with hypnotherapy in the three years preceding potential inclusion
- Children currently receiving psychological treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Leiden
Leiden
Shelley van der Veek, PhD, +31 715273767, sveek@fsw.leidenuniv.nl
Simone Vogelaar, PhD, s.vogelaar@fsw.leidenuniv.nl
About this study
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:
Read more
- 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?
- 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.
Read the detailed 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.
- Conditions
- Healty Volunteers
- Being tested
- standardized audio hypnosis recordings for healthy children at primary school
- Keywords
- mental health, primary school, hypnosis, self-esteem, resilience
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized audio hypnosis recordings for healthy children at primary schoolBehavioural
8 different audio hypnosis recordings hat chidlren will listen too at a daily basis (one recording per day)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Behavioral: standardized audio hypnosis recordings for healthy children at primary school |
| Group B | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in self-esteem between group A and B.
The primary objective is to study the effect of daily listening for 6 weeks to the hypnosis recordings on the change in self-esteem compared to controls 6 weeks after baseline. It will be measured by the Rosenberg Self Esteem scale for Children. This gives a score between 0 to 30 and higher scores mean more self-esteem.
Measured: difference between baseline and the end of listening to the exercises at 6 weeks.
Secondary outcomes (3)
Improvement in resilience on short and long term.
Difference in improvement in resilience as measured by the Connor-Davidson Resilience Scale for Children (CD-RISC) between group A and Group B. The Connor-Davidson Resilience scale (CD-RISC) comprises of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience.
Measured: CD-RISC will measured between baseline and six weeks and between baseline and after 6 months.
Improvement in psychosocial functioning on short and long term..
Change in improvement in psychosocial functioning as measured by the Strength and Difficulties Questionnaire (SDQ) between group A and B. The SDQ asks about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales:
- emotional symptoms (5 items)
- conduct problems (5 items)
- hyperactivity/inattention (5 items)
- peer relationship problems (5 items)
- prosocial behaviour (5 items) All questions result in 1 to 4 points with higher scores reflecting more problems.
Measured: The difference in SDQ will be measured between baseline and six weeks, and between baseline and after 6 months.
Stress reduction at short and long term.
Change in stress will be compared between group A and B. They are measured by the Chronic Stress Questionnaire for children and adolescents (CSQ-CA) (Stress Vragenlijst Voor Kinderen). It consists of 19 items, including "I often overthink things" and "Ifeel like I have to do too many things at the same time". The items have to be scored on a 4-point scale from "this does not apply to me at all", "this usually does not apply to me", thus usually applies to me", to "this completely applies to me". Higher scores reflect more stress.
Measured: The CSQ-CA will be measured at baseline, 6 weeks, and 6 months in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start31 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healty VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 with hypnosis exercises o iprove mental well being (Group A) or after 6 months (group B). Group B will therefore be the control group of A.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University
- Responsible party
- Principal investigator, Arine Vlieger, St. Antonius Hospital
- Investigators
- Arine M Vlieger, MD,PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157358
- Sponsor's protocol ID
- NL 87558.100.24
- Acronym
- Breinbaas
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will be shared
Publications
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.
PubMed 28346581
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues
- ClinicalTrials.gov ID
- NCT07157358
- Acronym / sponsor ID
- Breinbaas / NL 87558.100.24
- Conditions
- Healty Volunteers
- Keywords
- mental health, primary school, hypnosis, self-esteem, resilience
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- Leiden University
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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 with hypnosis exercises o iprove mental well being (Group A) or after 6 months (group B). Group B will therefore be the control group of A.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: standardized audio hypnosis recordings for healthy children at primary schoolChildnre 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. |
| Group B | No intervention | –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. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Children treated with hypnotherapy in the three years preceding potential inclusion
- Children currently receiving psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized audio hypnosis recordings for healthy children at primary school8 different audio hypnosis recordings hat chidlren will listen too at a daily basis (one recording per day) | Behavioural | Group A |
Primary outcome
Difference in change in self-esteem between group A and B.
Time frame: difference between baseline and the end of listening to the exercises at 6 weeks.
The primary objective is to study the effect of daily listening for 6 weeks to the hypnosis recordings on the change in self-esteem compared to controls 6 weeks after baseline. It will be measured by the Rosenberg Self Esteem scale for Children. This gives a score between 0 to 30 and higher scores mean more self-esteem.
3 secondary outcomes
Improvement in resilience on short and long term.
Time frame: CD-RISC will measured between baseline and six weeks and between baseline and after 6 months.
Improvement in psychosocial functioning on short and long term..
Time frame: The difference in SDQ will be measured between baseline and six weeks, and between baseline and after 6 months.
Stress reduction at short and long term.
Time frame: The CSQ-CA will be measured at baseline, 6 weeks, and 6 months in both groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Background: PubMed 28346581Rutten 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.
- This Dutch website gives information on the hypnosis exercises used in this studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arine M Vlieger, MD,PhD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized audio hypnosis recordings for healthy children at primary school in people with Healty Volunteers, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelley van der Veek, PhD (0031-715273767, sveek@fsw.leidenuniv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in self-esteem between group A and B. (time frame: difference between baseline and the end of listening to the exercises at 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.