The primary objective is to study the effect of daily listening for 6 weeks to the Breinbaas hypnosis recordings on self esteem compared to controls. Secondary objective(s) are studying the effect of daily listening to the Breinbaas hypnosis…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the difference in self-esteem at week six
compared to the baseline. This is measured using the "Rosenberg Self-Esteem
Scale for Children." As one of the secondary outcome measures, it will also be
measured at 6 months.
Secondary outcome
Secondary outcome measures include the difference between baseline and 6 weeks
or 6 months in terms of resilience, measured using the "Connor-Davidson
Resilience Scale for Children". Additionally, improvements in psychosocial
functioning ("Strength and Difficulties Questionnaire"), stress ("Chronic
Stress Questionnaire for Children and Adolescents"), and sleep will be assessed
at these time points.
There is also a short, self-designed questionnaire for parents regarding
short-term effects on mood, sleep, behavior, and social interactions at 6
weeks. .
Background summary
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.ue to long
waiting lists, teenagers have to wait long for adequate treatment. Prevention
of these mental health problems is therefore of great importance.
Study objective
The primary objective is to study the effect of daily listening for 6 weeks to
the Breinbaas hypnosis recordings on self esteem 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
Study design: This is a randomized, controlled, open-label study with a
duration of six months. All children from the same school will be randomized to
start immediately with the online program (Group A) or after six months (Group
B). Group B will, therefore, be the control group of A.
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. During the listening
stories children will receive suggestions for improvement of self-esteem,
self-love, relaxation etc.
Study burden and risks
Hypnosis is a very safe intervention; it is being used in the Netherlands by
hundreds of children with irritable bowel syndrome and functional abdominal
pain. Side effects are rare. Some children may mention some dizziness during
the first time they listen to the exercises, and we then advocate them to
listen while lying in bed. Rarely, children may feel some emotions coming up,
like sadness. This can occur during the relaxation, which is a part of the
trance induction. Explanaton on this phenomen will be given before start of the
exercises including advice on how to deal with it.The possible benefits are
that hypnosis can improve self-esteem and resilience and hopefully decrease
feelings of anxiety and depression, and improve quality of life at adolescence.
Koekoekslaan 1
3435 CM Nieuwegein 3435CM Nieuwegein
NL
Koekoekslaan 1
3435 CM Nieuwegein 3435CM Nieuwegein
NL
Listed location countries
Age
Inclusion criteria
Children visiting group 6 or 7 of the participating primary schools will be
invited to participate. Schools will be recruited in 3 areas in the
Netherlands: in and around the cities of Eindhoven, Leiden, and Utrecht.
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
a. Fluent in Dutch
b. Permission of the parents to participate in this study and to listen daily
to one of the Breinbaas hypnosis exercises (maximum 20 minutes per day)
c. Access to an electronic device to listen to the Breinbaas exercises (phone,
tablet, computer)
Exclusion criteria
a. Children treated with hypnotherapy in the three years preceding potential
inclusion
b. Children currently receiving psychological treatment
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87558.100.24 |