Qualitative Analysis of Factors Affecting Perioperative Sleep Quality During Scheduled Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Determination of factors influencing sleep quality
研究概览
简要总结
Many epidemiological studies report that insomnia is common after fifty years in the general population but also in the post-operative period of surgery. Preoperatively, sleep quality can be disturbed by fear of general anesthesia and surgery. Postoperatively, it seems to be altered by pain, the ambient environment and night care.
Literature shows that the occurrence of post-operative sleep disorders seems to lead to (increased) hypnotic consumption in patients who did not consume them in the pre-operative phase with known risks of dependence.
Nowadays , general anesthesia is widely practiced worldwide. However, despite continuous improvement in techniques, a large number of patients still experience poor quality postoperative sleep, even with short-term anesthesia.
It therefore appears that general anesthesia disrupts the circadian rhythm of patients, even if the mechanisms are still poorly understood.
Thus, sleep deprivation could be responsible of physiological alterations that are still unknown, such as delayed healing or impaired respiratory muscle performance, promoting postoperative complications.
The aim of this study is to identify the factors impacting the quality of sleep of patients undergoing scheduled surgery during the first postoperative night. And its implication on the occurrence of drowsiness described by the patient the day after their surgical intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male or female subject aged 18 years or older;
- •Subject scheduled to undergo surgery under general anesthesia (orthopedic, thoracic, vascular or visceral surgery);
- •Subject able to complete a self-administered questionnaire;
- •Subject having given oral consent;
排除标准
- •Subject wishing to discontinue participation in the study before the end;
- •Subject for whom the surgical procedure could not be performed after admission to the operating room (whatever the reason);
- •Subject for whom the surgical procedure was performed urgently before the date initially scheduled (whatever the reason);
- •Subject for whom a serious perioperative complication occurred during the surgical procedure
研究组 & 干预措施
Patients requiring scheduled surgery with post-operative hospitalization
Patients will pass questionnaires to assess their postoperative sleep quality
干预措施: Questionnaires (Other)
结局指标
主要结局
Determination of factors influencing sleep quality
时间窗: Day 1 post-operative
Sleep quality will be assessed using a self-questionnaire called Spiegel. It includes 3 items assessing sleep with a gradation from 0 to 5. An overall score is calculated, ranging from 0 (worst possible experience) to 15 (very good quality of sleep).
次要结局
- Determination of Sleepiness(Day 1 post-operative)
- Determination of patient's perioperative satisfaction(Day 1 post-operative)