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

Completed

• Conditions: General Anesthesia; Preoperative Anxiety; Postoperative Pain; Postoperative Sleep Quality
• Interventions: Procedure: patients undergoing gynecological surgery under general anesthesia

• Registration Number: NCT04619979
• Lead Sponsor: Shengjing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-06
• Study Start: 2021-10-01
• Primary Completion: 2022-03-01
• Status Verified: 2022-08
• Study Completion: 2022-08-10
• Last Update Submitted: 2022-08-13
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preoperative anxiety group	patients undergoing gynecological surgery under general anesthesia	-
Non-preoperative anxiety group	patients undergoing gynecological surgery under general anesthesia	-

Primary Outcome Measures

Name	Time	Method
postoperative pain	24 hours after surgery	evaluate Numerical Rating Scale score (0: no pain to 10: severe pain)
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)
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

Trial Locations

Locations (1)

Shengjing Hospital; 🇨🇳 Shenyang, Liaoning, China