Effect of Melatonin Patches on Sleep Quality in Patients Undergoing Urological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- sleep quality
研究概览
简要总结
Patients undergoing urological surgery may experience a decrease in sleep quality due to many factors such as hospitalization, different environment, pain, stress and anesthesia. After surgery, melatonin secretion decreases and circadian rhythm becomes irregular in patients. This problem can lead to sleep disorders in patients. Melatonin is an important hormone that regulates both sleep and circadian rhythms. The aim of this study is to observe the effect of a melatonin skin patch designed to produce melatonin in a way that ensures a stable increase in melatonin levels in the blood, on patients undergoing urological surgery.
详细描述
The purpose of this study was to observe the effect of a melatonin skin patch designed to produce melatonin, which would provide a stable increase in blood melatonin levels, on patients undergoing urological surgery. The patients were applied a melatonin patch before surgery. The other group received routine nursing care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have undergone planned urological surgery,
- •Those who receive melatonin patch therapy,
- •Those who are between the ages of 18-70,
- •Those whose hemodynamic conditions are stable will be included.
排除标准
- ••Patients who used different sleeping pills/hypnotics during the study period,
- •Patients with delirium/psychiatric illness,
- •Patients with hearing and speech problems will not be included.
研究组 & 干预措施
Melatonin group
Before the patient goes to sleep, the nurse will ensure that the room is quiet and dark, as exposure to light suppresses melatonin. First, the introductory characteristics form and the Richard's-Campbel Sleep Scale will be completed for patients assigned to the melatonin group. Melatonin patches will be placed by a nurse not involved in the study at 8:00 PM before going to sleep (on the upper chest or forearm, as determined by the patient). The patches will remain on for an average of 6-10 hours, depending on the patient's preferred sleep hygiene. If a patient wishes to have the patch removed during the night, they will be instructed to ask the clinic nurse to do this. The Richard's-Campbel Sleep Scale will be completed when the patient is fully awake after the melatonin patch is removed one hour before the patient goes to the operating room on the morning of the surgery.
干预措施: A skin patch (2.1 mg melatonin) was applied to the melatonin group. The melatonin patches will be placed at 8:00 PM (on the upper chest or forearm, as determined by the patient) before going to sleep (Other)
control group
Patients in the control group will not undergo any intervention other than the standard care protocol.
结局指标
主要结局
sleep quality
时间窗: The Richards-Campbell Sleep Scale will be completed at 20:00 the evening before surgery and at 06:00 the morning of surgery.
Sleep is examined in the parameter and scored between 100 'very suitable' and 0 'not suitable'. The higher the score obtained from the scale, the higher the patient's sleep quality is considered.
次要结局
未报告次要终点
研究者
Cagla Toprak
Dr.
Atlas University