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

NCT04619979 | Completed

• 1 other identifier: Preoperative anxiety and sleep
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• postoperative pain

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

  24 hours after surgery

• evaluate postoperative sleep quality by using Athens insomnia scale

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

  first night before surgery

• evaluate postoperative sleep quality by using Athens insomnia scale

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

  first night after surgery

• evaluate postoperative sleep quality by using Athens insomnia scale

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

  third night after surgery

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

  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

  baseline (before the surgery)

Study Arms (2)

preoperative anxiety group

Procedure: patients undergoing gynecological surgery under general anesthesia

Non-preoperative anxiety group

Procedure: patients undergoing gynecological surgery under general anesthesia

Interventions

patients undergoing gynecological surgery under general anesthesia PROCEDURE

patients undergoing gynecological surgery under general anesthesia

Non-preoperative anxiety group; preoperative anxiety group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study enrolled patients undergoing gynecological surgery under general anesthesia at Shengjing Hospital of China Medical University.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: October 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: August 10, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

CN (1)