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临床试验 NCT07157358 (Breinbaas) 针对Healty Volunteers目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues (Breinbaas) 345 运动
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临床试验NCT07157358 (Breinbaas)是一项针对Healty Volunteers的干预性研究试验，目前试验状态为招募中。试验始于2025年7月31日，计划招募345名患者。该研究由St. Antonius Hospital主导，预计于2026年9月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月5日。
简要概括
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 healt...
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...
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Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues
疾病
Healty Volunteers出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- Breinbaas
- NL 87558.100.24
NCT编号
实际开始日期
2025-07-31
最近更新发布
2025-09-05
预计完成日期
2026-09-01
计划入组人数
345
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
mental health
primary school
hypnosis
self-esteem
resilience
primary school
hypnosis
self-esteem
resilience
主要目的
预防
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Group A 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. | standardized audio hypnosis recordings for healthy children at primary school 8 different audio hypnosis recordings hat chidlren will listen too at a daily basis (one recording per day) |
无干预Group B 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. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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. | 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.. | 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. | 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. | 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. | The CSQ-CA will be measured at baseline, 6 weeks, and 6 months in both groups. |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
9 Years
适龄性别
全部
接受健康志愿者
是
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) -
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
St. Antonius Hospital莱顿大学研究责任方
Arine Vlieger, 主要研究者, Pediatrician, MD, PhD, St. Antonius Hospital
研究中心联系人
联系人: Shelley van der Veek, PhD, 0031-715273767, [email protected]
联系人: Simone Vogelaar, PhD, 0031-71-5273830, [email protected]
1 位于 1 个国家/地区的研究中心
University Leiden, Leiden, Netherlands
Shelley van der Veek, PhD, 联系人, +31 715273767, [email protected]
Simone Vogelaar, PhD, 联系人, [email protected]
招募中