Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Difference in change in self-esteem between group A and B.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •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) -
排除标准
- •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
结局指标
主要结局
Difference in change in self-esteem between group A and B.
时间窗: 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.
次要结局
- 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.)
研究者
Arine Vlieger
Pediatrician, MD, PhD
St. Antonius Hospital