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

Sponsor
Shengjing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04619979
Collaborator
(none)
356
1
10.3
34.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: patients undergoing gynecological surgery under general anesthesia

Study Design

Study Type:
Observational
Actual Enrollment :
356 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effects of Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy
Actual Study Start Date :
Oct 1, 2021
Actual Primary Completion Date :
Mar 1, 2022
Actual Study Completion Date :
Aug 10, 2022

Arms and Interventions

Arm Intervention/Treatment
preoperative anxiety group

Procedure: patients undergoing gynecological surgery under general anesthesia
patients undergoing gynecological surgery under general anesthesia

Non-preoperative anxiety group

Procedure: patients undergoing gynecological surgery under general anesthesia
patients undergoing gynecological surgery under general anesthesia

Outcome Measures

Primary Outcome Measures

  1. postoperative pain [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 [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 [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 [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)". [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shengjing Hospital Shenyang Liaoning China 110004

Sponsors and Collaborators

  • Shengjing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanchao Yang, principal investigator, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT04619979
Other Study ID Numbers:
  • Preoperative anxiety and sleep
First Posted:
Nov 6, 2020
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2022