임상 레이더 AI | ||
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임상시험 NCT07157358 (Breinbaas)은(는) Healty Volunteers에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues (Breinbaas) 345 운동
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07157358 (Breinbaas)은(는) Healty Volunteers에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 7월 31일에 시작되어 345명의 참여자를 모집하고 있습니다. St. Antonius Hospital이(가) 진행하며, 2026년 9월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 5일에 갱신되었습니다.
간단한 개요
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...
상세한 설명
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...
더 보기공식 제목
Online Medical Hypnosis Exercises to Improve Mental Health in Primary School Children and Prevent Future Mental Health Issues
질환명
Healty Volunteers출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- Breinbaas
- NL 87558.100.24
NCT 번호
실제 연구 시작일
2025-07-31
최신 업데이트 게시
2025-09-05
예상 연구 완료일
2026-09-01
계획된 등록 인원
345
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
mental health
primary school
hypnosis
self-esteem
resilience
primary school
hypnosis
self-esteem
resilience
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Group 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) |
비개입Group 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. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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. |
참여 도우미
적격성 기준
연령대
어린이
최소 연령
9 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
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 Hospital레이던 대학교연구 책임자
Arine Vlieger, 책임연구자, Pediatrician, MD, PhD, St. Antonius Hospital
연구 대표 연락처
연락처: Shelley van der Veek, PhD, 0031-715273767, [email protected]
연락처: Simone Vogelaar, PhD, 0031-71-5273830, [email protected]
1 1개국에 임상시험 장소
University Leiden, Leiden, Netherlands
Shelley van der Veek, PhD, 연락처, +31 715273767, [email protected]
Simone Vogelaar, PhD, 연락처, [email protected]
모집중