## Protocol Section
### Identification Module
**NCT ID:** NCT04619979

**Brief Title:** Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy

**Official Title:** Effects of Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy

#### Organization Study ID Info
**ID:** Preoperative anxiety and sleep
#### Organization
**Class:** OTHER
**Full Name:** Shengjing Hospital
### Status Module
#### Completion Date
**Date:** 2022-08-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-17

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-10-01

**Type:** ACTUAL

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2020-11-06
**Type:** ACTUAL
**Study First Submit Date:** 2020-11-02
**Study First Submit QC Date:** 2020-11-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shengjing Hospital

#### Responsible Party

**Investigator Affiliation:** Shengjing Hospital

**Investigator Full Name:** Yanchao Yang

**Investigator Title:** principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- General Anesthesia

- Postoperative Pain

- Postoperative Sleep Quality

- Preoperative Anxiety

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 356

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: patients undergoing gynecological surgery under general anesthesia

**Label:** preoperative anxiety group

#### Arm Group 2

**Intervention Names:**

- Procedure: patients undergoing gynecological surgery under general anesthesia

**Label:** Non-preoperative anxiety group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Non-preoperative anxiety group

- preoperative anxiety group

**Description:** patients undergoing gynecological surgery under general anesthesia

**Name:** patients undergoing gynecological surgery under general anesthesia

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** postoperative pain

**Time Frame:** 24 hours after surgery

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

**Measure:** evaluate postoperative sleep quality by using Athens insomnia scale

**Time Frame:** first night before surgery

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

**Measure:** evaluate postoperative sleep quality by using Athens insomnia scale

**Time Frame:** first night after surgery

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

**Measure:** evaluate postoperative sleep quality by using Athens insomnia scale

**Time Frame:** third night after surgery

**Description:** 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

**Measure:** preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".

**Time Frame:** baseline (before the surgery)

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shenyang

**Country:** China

**Facility:** Shengjing Hospital

**State:** Liaoning

**Zip:** 110004

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Imaging

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

### Misc Info Module

- Version Holder: 2024-05-24
