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Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy

Effects of Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04619979
Enrollment
356
Registered
2020-11-06
Start date
2021-10-01
Completion date
2022-08-10
Last updated
2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Postoperative Pain, Postoperative Sleep Quality, Preoperative Anxiety

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.

Interventions

PROCEDUREpatients undergoing gynecological surgery under general anesthesia

patients undergoing gynecological surgery under general anesthesia

Sponsors

Shengjing Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain24 hours after surgeryevaluate Numerical Rating Scale score (0: no pain to 10: severe pain)
evaluate postoperative sleep quality by using Athens insomnia scalefirst night before surgeryevaluate postoperative sleep by using Athens insomnia scale(\<4: no insomnia; 4-6: suspicious insomnia; \>6: insomnia)
preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS).baseline (before the surgery)evaluate the preoperative anxiety score before the surgery, APAIS contains 6 items rated on a five-point Likert scale, which represents two scales: anxiety (items 1, 2, 4, and 5) and need for information (items 3 and 6) Accordingly, the maximal score of the entire APAIS (APAIS-T) is 30 and the one expressing the patient's need for information (APAIS-I) is 10. The maximal score of the two items concerning anxiety about anesthesia (APAIS-A-An) and surgery (APAIS-A-Su) is also 10 each, resulting in a maximal score of 20 for total preoperative anxiety (APAIS-A-T). And APAIS-A-T \> 10 was used as a cut-off to define patients with high anxiety, the higher the score, the more serious the pre-operative anxiety is

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026