Validation of Smartwatch Technology for Preoperative Monitoring of Sleep Quality, Anxiety, and Vital Signs in Patients Undergoing Disc Herniation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Blood Oxygen Saturation (SpO2) (Medical-Grade)
研究概览
简要总结
This study aims to verify the accuracy of blood pressure, heart rate, blood oxygen saturation, anxiety level, and sleep cycle data measurements obtained from Samsung smartwatches compared to the currently accepted method used in patients with disc herniation undergoing the preoperative period.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years and older
- •Currently receiving preoperative care/assessment for disc herniation surgery.
- •No history of any cardiovascular disease other than controlled hypertension.
- •Willingness to wear the smartwatch for a minimum of 8 consecutive hours during the night before surgery.
- •Ability to follow all instructions related to the smartwatch operation and data collection independently.
- •No known allergy to nickel.
排除标准
- •Patients who are currently receiving prescribed medication specifically for sleep in the clinical setting.
- •Refusal or unwillingness to participate in the study.
- •The participant fails to wear the smartwatch correctly or appropriately as per study instructions, leading to incomplete or unreliable data collection.
研究组 & 干预措施
Preoperative Disc Herniation Patients
This group consists of hospitalized adult patients scheduled for intervertebral disc herniation surgery whose preliminary examinations are complete. Measurements will be taken at two different time points: the night before surgery and the morning of the surgery. Patients' vital signs (blood pressure, pulse, oxygen saturation) will be determined using standard medical devices, while anxiety and sleep quality will be determined via validated clinical scales. All these values will be collected simultaneously using smartwatches (Samsung).
结局指标
主要结局
Blood Oxygen Saturation (SpO2) (Medical-Grade)
时间窗: Evening before surgery; Morning before surgery.
SpO2 will be taken using a finger pulse oximeter on the finger of the same arm as the smartwatch at each time point.
Blood Pressure (BP) (Medical-Grade)
时间窗: Evening before surgery; Morning before surgery.
One measurement will be taken from both the patient's right and left arm using a calibrated medical-grade sphygmomanometer (BP cuff) at each time point. Both systolic and diastolic pressure will be recorded separately.
Heart Rate (HR) (Medical-Grade)
时间窗: Evening before surgery; Morning before surgery.
HR will be taken using a finger pulse oximeter on the finger of the same arm as the smartwatch at each time point.
State-Trait Anxiety Inventory (STAI) Score
时间窗: Evening before surgery; Morning before surgery.
The evening before surgery: Both the State-Trait Anxiety Inventory (STAI) State and Trait anxiety scores will be recorded. The morning before surgery: Only the State Anxiety Inventory score will be recorded. Both the State and Trait forms of the STAI include reverse-scored items. Total scores are calculated for each form, with higher scores reflecting higher levels of anxiety.
Richards-Campbell Sleep Questionnaire (RCSQ) Score
时间窗: Evening before surgery; Morning before surgery
Sleep quality will be measured twice using the Richards-Campbell Sleep Questionnaire (RCSQ): 1) The evening before surgery, to assess the night immediately before the decision to operate. 2) The morning before surgery, assess the preoperative night spent in the hospital. The total score is calculated using the first five items of the scale, with the noise item excluded from scoring. Scores of 0-25 indicate very poor sleep, while scores of 76-100 indicate very good sleep.
Heart Rate (HR) (Measured via Wrist)
时间窗: Evening before surgery; Morning before surgery.
Heart rate (HR) will be measured at the wrist using a smartwatch. During measurement, a simultaneous reference reading will be obtained from the finger of the same arm using a finger pulse oximeter, with the time interval between devices kept to a minimum.
Anxiety Metric (Measured via Wrist)
时间窗: Evening before surgery; Morning before surgery.
Anxiety level will be assessed using a smartwatch. The smartwatch categorizes anxiety into four levels: relaxed, low, moderate, and high. To minimize the potential influence of self-awareness of questionnaire results, the smartwatch-based assessment will be conducted after completion of the STAI.
Blood Pressure (BP) (Measured via Wrist)
时间窗: Evening before surgery; Morning before surgery.
Blood pressure will be measured using a smartwatch twice: once on the evening before surgery and once on the morning of surgery. On both occasions, the smartwatch-based measurement will be obtained immediately prior to the medical blood pressure measurement. All measurements will be obtained from the same preoperatively designated wrist without changing sides. Systolic and diastolic blood pressure values obtained from the smartwatch will be recorded separately.
Blood Oxygen Saturation (SpO2) (Measured via Wrist)
时间窗: Evening before surgery; Morning before surgery.
Peripheral oxygen saturation (SpO₂) will be measured at the wrist using a smartwatch. During measurement, a simultaneous reference reading will be obtained from the finger of the same arm using a finger pulse oximeter, with the time interval between devices kept to a minimum.
Sleep Quality (Measured via Wrist)
时间窗: Single report obtained from continuous monitoring during the entire Night Before Surgery (from the evening when the watch is put on until the morning).
Sleep will be continuously monitored using a smartwatch throughout the preoperative night. At the end of the monitoring period, sleep quality will be quantified using a score ranging from 0 to 100, with higher scores reflecting better sleep quality.
Sleep Duration (Measured via Wrist)
时间窗: Single report obtained from continuous monitoring during the entire Night Before Surgery (from the evening when the watch is put on until the morning).
Sleep duration will be continuously monitored using a smartwatch throughout the night. Total sleep duration will be reported in hours and minutes. In addition to total sleep duration, time spent in light sleep, REM sleep, wakefulness, and deep sleep will be reported as subcomponents. All sleep-related durations will be recorded separately in hours and minutes.
次要结局
未报告次要终点
研究者
Halil Kalaycı
Res. Asst.
TC Erciyes University
