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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-12
SponsorSt. Antonius Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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) -

Disqualifiers

Children treated with hypnotherapy in the three years preceding potential inclusion

Children currently receiving psychological treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

345 Participants
are divided into 2 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BNo intervention 0 interventions

Trial outcomes

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.

Time frame
difference between baseline and the end of listening to the exercises at 6 weeks.

Secondary outcomes

1

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.

Time frame
CD-RISC will measured between baseline and six weeks and between baseline and after 6 months.
2

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: 1. emotional symptoms (5 items) 2. conduct problems (5 items) 3. hyperactivity/inattention (5 items) 4. peer relationship problems (5 items) 5. prosocial behaviour (5 items) All questions result in 1 to 4 points with higher scores reflecting more problems.

Time frame
The difference in SDQ will be measured between baseline and six weeks, and between baseline and after 6 months.
3

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.

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

Other outcomes

1

Side-effects of listening to hypnosis exercises

Children will be asked if they had noticed any side-effects of using the program. Also, the number of times a child contacts the study team for side effects will be noted.

Time frame
This will be measured at T = 6 weeks.
2

Treatment adherence

The app, providing the hypnosis exercises, will monitor how often the children have listened to one of the exercises. Good treatment adherence will be defined as listening at least 4 times a week during 6 weeks.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

St. Antonius Hospital

Lead sponsor

Leiden University

Collaborator