Clinical trial NCT04619979: Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy
Official title: Effects of Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
Postoperative Pain
Postoperative Sleep Quality
Preoperative Anxiety
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study enrolled patients undergoing gynecological surgery under general anesthesia at Shengjing Hospital of China Medical University.

Brief summary: Sleep is a naturally occurring state of decreased arousal that is crucial for normal immune and cognitive function. Although surgery and anesthesia techniques have improved in recent years, sleep function and sleep cycles may still be altered perioperatively by surgery and other interventions under general anesthesia.Postoperative sleep fragmentation and poor sleep quality not only lead to hyperalgesia and delayed postoperative recovery, but can increase the risk of potential adverse effects, such as cognitive impairment, chronic pain and emotional disturbances, metabolic disorders, and pro-inflammatory changes. General anesthesia is a medically induced state of hyporesponsiveness that resembles natural sleep. Studies have shown that general anesthesia can lead to circadian rhythm time structure dyssynchrony, resulting in postoperative sleep disturbance, characterized by decreases in rapid eye movement (REM) and slow wave sleep (SWS). Previous studies have also reported that age, preoperative comorbidities, and severity of surgical trauma are independent factors associated with postoperative sleep disturbance. In addition, anxiety is an unpleasant sensation that compromises patients' comfort and well-being. A study by Ruis et al. estimated that 25-80% of patients admitted for surgery experienced preoperative anxiety, including fear of surgery and anesthesia-related fears. Furthermore, preoperative anxiety was recognized as a potential and preventable risk factor for severe postoperative pain and postoperative complications such as increased postoperative morbidity and mortality. Given that several prior studies have reported that preoperative anxiety has an effect on postoperative sleep quality in patients undergoing gynecological surgery, this study aimed to investigate the effect of preoperative anxiety on postoperative outcomes and sleep quality in patients undergoing gynecological surgery. Studying these results could enable us to better manage patients during the perioperative period to promote their postoperative recovery.


Eligibility criteria: The inclusion criteria were:

1. age between 18 and 75 years,
2. American Society of Anesthesiologists (ASA) medical status I or II,
3. laparoscopic hysterectomy, elective operation and surgery lasting 1-3 h.

The exclusion criteria included

1. cardiovascular disease,
2. chronic use of analgesics,
3. chronic use of antidepressants,
4. use of sleep-promoting drugs,
5. sleep disorders,
6. sleep apnea syndrome,
7. history of abnormal surgery or recovery from anesthesia,
8. psychosis,
9. patients with impaired verbal communication,
10. unwillingness to provide informed consent.

Primary outcomes:
measure: postoperative pain
timeFrame: 24 hours after surgery
measure: evaluate postoperative sleep quality by using Athens insomnia scale
timeFrame: first night before surgery
measure: evaluate postoperative sleep quality by using Athens insomnia scale
timeFrame: first night after surgery
measure: evaluate postoperative sleep quality by using Athens insomnia scale
timeFrame: third night after surgery
measure: preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".
timeFrame: baseline (before the surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
References: