NCT06589739尚未招募不适用
Drainage Thoracique Assisté Par Un Casque De Réalité Virtuelle
Central Hospital, Nancy, France0 个研究点目标入组 40 人开始时间: 2024年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Pain - Chest drain
研究概览
简要总结
Clinical study aiming to investigate the potential benefit of the use of virtual reality helmet as a distractor during chest drain insertion to alleviate patients' pain and anxiety
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of chest drain insertion for pleural effusion or primary spontaneous pneumothorax
- •Patient who received clear and loyal information abotu the study protocol
- •Patient who consented to participate to the study
- •Patient aged 18 years old or older
- •Patient affiliated to the french health system
排除标准
- •Patient aged less than 18 years old
- •Patient in emergency situation
- •Patient with severe heart condition
- •Patient allergic to silicone
- •Patient with severe psychiatric or mental disorder
- •patient with binocular vision anomaly
- •patient with pacemaker or defibrillator
- •patient wearing a hearing aid that cannot be removed
- •Patients under the influence of alcohol or drugs, nausea, fatigue, emotional or anxiety disorders, migraine, headaches, infectious disease
- •Patient with past medical history of epilepsia or convulsion
- •- Persons covered by articles L. 1121-5 and L1121-8 of the French Public Health Code:
- •Pregnant, parturient or breast-feeding women,
- •Persons of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
- •adults unable to give their consent
- •Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-
- •Person able to give consent but unable to write
- •Person able to give consent but unable to read French
- •Patient unable to consent to the study
结局指标
主要结局
Pain - Chest drain
时间窗: During chest drain insertion
Visual Analogic Scale
次要结局
- Anxiety - Chest drain(During chest drain insertion)
- Pain - Antalgic consumption(during the 24 hours after chest drain insertion)
- Pain - 30 minutes(30 minutes after chest drain insertion)
- Anxiety - 30 minutes(30 minutes after chest drain insertion)
- feasibility(During chest drain insertion)
研究者
STREIT Arthur
Doctor
Central Hospital, Nancy, France
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