Skip to main content
OpenTrials
Completed

NCT Number: NCT04619979

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

General Anesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Postoperative Sleep Quality Preoperative Anxiety Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria were:

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

The exclusion criteria included

  • cardiovascular disease,
  • chronic use of analgesics,
  • chronic use of antidepressants,
  • use of sleep-promoting drugs,
  • sleep disorders,
  • sleep apnea syndrome,
  • history of abnormal surgery or recovery from anesthesia,
  • psychosis,
  • patients with impaired verbal communication,
  • unwillingness to provide informed consent.

Treatment and study plan

patients undergoing gynecological surgery under general anesthesia

Procedure

patients undergoing gynecological surgery under general anesthesia

Primary outcomes

  1. postoperative pain

    Time frame: 24 hours after surgery

    evaluate Numerical Rating Scale score (0: no pain to 10: severe pain)

  2. evaluate postoperative sleep quality by using Athens insomnia scale

    Time frame: first night before surgery

    evaluate postoperative sleep by using Athens insomnia scale(<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)

  3. evaluate postoperative sleep quality by using Athens insomnia scale

    Time frame: first night after surgery

    evaluate postoperative sleep by using Athens insomnia scale (<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)

  4. evaluate postoperative sleep quality by using Athens insomnia scale

    Time frame: third night after surgery

    evaluate postoperative sleep by using Athens insomnia scale (<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)

  5. preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 6, 2020
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.