## Protocol Section
### Identification Module
**NCT ID:** NCT06419088

**Brief Title:** Effect of Preoperative Individualized Education on Anxiety and Recovery.

**Official Title:** Effect of Preoperative Individualized Education on Anxiety and Recovery in Patients Undergoing Minimally Invasive Lung Surgery

#### Organization Study ID Info
**ID:** EPIEAR
#### Organization
**Class:** OTHER
**Full Name:** Fujian Medical University Union Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-12

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fujian Medical University Union Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Researchers aim to investigate whether individualized preoperative education for patients is beneficial in reducing perioperative anxiety, promoting postoperative recovery, and enhancing postoperative quality of life. The educational content will cover aspects such as the surgery procedure, anesthesia, postoperative pain and anxiety management, recovery time, and any potential required treatments. All participants will be administered a questionnaire before the surgery to evaluate their specific concerns and fears. The intervention group will receive preoperative education through audio-visual materials followed by targeted preoperative counseling, while the control group will receive routine preoperative education.

**Detailed Description:** Patients who met the research criteria were consulted prior to surgery, during which the research objectives were explained, and written consent was obtained. Following baseline assessment, patients were randomly allocated to either the individualized education group or the routine education group. Sociodemographic information was collected through face-to-face interviews conducted in the ward. Additionally, levels of anxiety and adverse events (sleep, pain, nausea, vomiting) were measured using the Visual Analog Scale (VAS) and Hospital Anxiety and Depression Scale (HADS). Patient anxieties regarding different aspects were assessed using specific concerns and fears scales.

The intervention group received individualized educational interventions utilizing audiovisual materials. Based on identified personalized educational needs, researchers administered individualized preoperative education to the intervention group in the ward. Patients in the control group received only routine preoperative education from clinical nurses.

The second assessment was conducted before patients were transferred to the operating room. Anxiety levels and adverse events (preoperative sleep, pain, nausea, and vomiting) were assessed using HADS and VAS. Postoperatively, pain, nausea, vomiting, and coughing were evaluated three times daily for the first three days (every 8 hours) using the Visual Analog Scale (VAS), and sleep was assessed daily using the Athens Insomnia Scale (AIS). Chronic symptoms and quality of life were assessed at postoperative weeks 1, 2, 4, 12, 26, and 52. Chronic cough was evaluated using the Leicester Cough Questionnaire, and chronic pain was evaluated using the Brief Pain Inventory. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and HADS were used for continuous assessment of quality of life, anxiety, and depression status.

### Conditions Module

**Conditions:**

- Education

**Keywords:**

- Preoperative education

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 156

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** received individualized educational interventions utilizing audiovisual materials

**Intervention Names:**

- Other: Preoperative individualized education

**Label:** individualized education group

**Type:** OTHER

#### Arm Group 2

**Description:** only routine preoperative education

**Label:** standard education group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- individualized education group

**Description:** Based on the identified individual education needs, the researcher implemented audio-visual education to the intervention group in the ward.

**Name:** Preoperative individualized education

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Change in anxiety intensity scores

**Measure:** Anxiety status

**Time Frame:** Before and after education, 12 months after surgery

**Description:** The Visual Analog Scale (VAS) was used to evaluate the intensity of pain, where 0 meant no pain, and 10 - the most severe pain.

**Measure:** Postoperative pain

**Time Frame:** Baseline, postoperative days 1,2,3

**Description:** The Visual Analog Scale (VAS) was used to evaluate the intensity of nausea and vomiting

**Measure:** Postoperative nausea and vomiting

**Time Frame:** Baseline, postoperative days 1,2,3

**Description:** Change in Athens Insomnia Scale

**Measure:** Sleep disorders

**Time Frame:** Baseline, postoperative days 1,2,3

#### Secondary Outcomes

**Description:** The incidence of common postoperative complications

**Measure:** Postoperative Complications

**Time Frame:** 12 months after surgery

**Description:** Change from baseline in quality of life scores on the European Organisation for Research and Treatment of Cancer 30 item Quality of Life Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.

**Measure:** Quality of life after surgery

**Time Frame:** Baseline, 12 months after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Aged 18 or above;
2. Received single-port thoracoscopic surgery;
3. Volunteered to participate in the study and signed an informed consent form.

Exclusion Criteria:

1. Presence of a mental disorder
2. Preoperative pain
3. Pregnancy
4. Presence of other tumours requiring treatment.

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 757860733@qq.com

**Name:** Maohui Chen, Prof

**Phone:** 18659181171

**Role:** CONTACT

**Contact 2:**

**Email:** 1204382231@qq.com

**Name:** Yizhou Huang

**Phone:** 13959568242

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fuzhou

**Contacts:**

***Contact 1:***

- **Email:** 757860733@qq.com

- **Name:** Maohui Chen, Prof

- **Phone:** 18659181171

- **Role:** CONTACT

***Contact 2:***

- **Email:** 1204382231@qq.com

- **Name:** Yizhou Huang

- **Phone:** 13959568242

- **Role:** CONTACT

**Country:** China

**Facility:** Fujian Medical University Union Hospital

**State:** Fujian

**Status:** RECRUITING

**Zip:** 350001

#### Overall Officials

**Official 1:**

**Affiliation:** Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu

**Name:** Chun Chen, Prof

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
