Validity and Reliability of the French Translation of the Richards-Campbell Questionnaire for Assessing Sleep in the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 4
- 主要终点
- Validation of the French translation of the Richards-Campbell questionnaire
研究概览
简要总结
The validation of a sleep questionnaire (translated into French from a source questionnaire in English) will provide a reliable and easily administered tool for assessing sleep quality in intensive care, enabling better identification of patients at risk of sleep disorders and other associated complications, in particular ventilatory weaning difficulties.
详细描述
Sleep disturbance in intensive care is influenced by a number of factors, such as environmental nuisances (noise, light, repeated interruptions), treatments (sedation, analgesia, mechanical ventilation) and the severity of the acute pathology that led to admission. Consequences include alterations to the immune system, neuropsychiatric disorders and impaired functional recovery.
Current management of these disorders remains limited:
- No pharmacological treatment has clearly demonstrated its efficacy on sleep quality in intensive care.
- Interventions aimed at modulating environmental nuisances (reducing noise, reducing light exposure, respecting day/night cycles) have shown limited effects.
- According to the available data, individual devices (eye masks, earplugs) have not significantly improved sleep architecture.
In this context, the Richards-Campbell questionnaire (RCSQ) represents an interesting alternative for subjectively assessing sleep in intensive care patients. This questionnaire, specifically designed for these patients, provides a simple and rapid assessment of sleep disturbances. The validation of a French version of the RCSQ meets a need to standardise assessment practices in France and to gain a better understanding of the factors influencing sleep quality in intensive care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient aged ≥ 18 years
- •Hospitalised in intensive care for at least 24 hours
- •Able to understand and answer questionnaires
- •Unsedated (discontinued for 24 hours) presenting a Richmond Sedation Agitation Scale score between ≥-2 and ≤ +1
- •Fluent in French
- •Having given oral consent for participation in the study
- •Person affiliated to a social security scheme.
排除标准
- •Patient refusal
- •Person deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship or curatorship)
- •Patient unable, for whatever reason, to read, understand or answer the questionnaires (visual problems, psychiatric or cognitive problems, etc.)
- •Patient already included in the study or another study evaluating sleep
结局指标
主要结局
Validation of the French translation of the Richards-Campbell questionnaire
时间窗: Visit Inclusion (V1, Day 1) and Visit V2 (Day 14)
Assessing the internal validity of the French translation of the Richards-Campbell questionnaire for analysing sleep quality in intensive care patients
次要结局
- Convergent validity of the results of the French RCSQ with other questionnaires(Visit Inclusion (V1, Day 1))
- Inter-rater agreement between patients and nurses(Visit Inclusion (V1, Day 1))
- Divergent validity of results(Visit Inclusion (V1, Day 1))
- French RCSQ's sensitivity to change(Visit V2 (Day 14))