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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
standardized audio hypnosis recordings for healthy children at primary school
Behavioral8 different audio hypnosis recordings hat chidlren will listen too at a daily basis (one recording per day)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Other outcomes
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
St. Antonius Hospital
Lead sponsor
Leiden University
Collaborator