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

NCT07157358 | Recruiting

• 1 other identifier: NL 87558.100.24
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief 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. The main questions it aims to answer are:

1. 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. 2.can listening to these exercsies prevent future metal health problems like feelings of depression or anxiety.

Conditions

Healty Volunteers

Keywords

mental health; primary school; hypnosis; self-esteem; resilience

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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..

  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.

  The CSQ-CA will be measured at baseline, 6 weeks, and 6 months in both groups.

Other Outcomes (2)

• Side-effects of listening to hypnosis exercises

  This will be measured at T = 6 weeks.

• Treatment adherence

  This will be monitored during the phase that the chidlren are listening, which is 6 weeks.

Study Arms (2)

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.

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.

Interventions

standardized audio hypnosis recordings for healthy children at primary school BEHAVIORAL

8 different audio hypnosis recordings hat chidlren will listen too at a daily basis (one recording per day)

Group A

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Fluent in Dutch
• Attending group 6 or 7 of a regular primary school in the Netherlands
• Permission of the parents to listen daily to one of the Breinbaas hypnosis exercises (maximum 20 minutes per day)
• Access to an electronic device to listen to the Breinbaas exercises (phone, tablet, computer) -

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Children currently receiving psychological treatment

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Leiden University: collaborator

Study Sites (1)

University Leiden

Leiden, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 28346581 BACKGROUND

Related Links

• This Dutch website gives information on the hypnosis exercises used in this study

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Arine M Vlieger, MD,PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley van der Veek, PhD

CONTACT

0031-715273767; sveek@fsw.leidenuniv.nl

Simone Vogelaar, PhD

CONTACT

0031-71-5273830; s.vogelaar@fsw.leidenuniv.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician, MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 5, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)