## Protocol Section
### Identification Module
**NCT ID:** NCT06424561

**Brief Title:** The Influence of Systematic Psychological Intervention on Patients About VSD Drainage Surgery

**Official Title:** The Influence of Systematic Psychological Intervention on Patients Undergoing VSD Drainage Surgery for Chronic Infected Wounds

#### Organization Study ID Info
**ID:** KY-2024-085
#### Organization
**Class:** OTHER
**Full Name:** The Fourth Affiliated Hospital of Zhejiang University School of Medicine
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-10-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** The Fourth Affiliated Hospital of Zhejiang University School of Medicine

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study focuses on providing clinical care to patients undergoing VSD drainage surgery for chronic wounds, while also paying attention to the impact of negative emotions such as depression and anxiety, as well as quality of life and social support, on the patients' physical and mental well-being. It observes the influence of psychology on patients.

**Detailed Description:** The chronic, difficult-to-heal wounds not recovering within the expected timeframe not only impact the quality of life for patients and hinder the recovery of the primary condition but also exacerbate their financial and psychological burdens, further affecting the quality of wound healing. The objective of this study is to employ psychological nursing interventions effectively combined with nursing techniques and communication strategies. By listening to patients' fears, anxieties, and tensions, it significantly alleviates their negative emotions, enhances compliance with medical advice, and predicts postoperative complications to mitigate them. Tailored and empathetic care, along with psychological counseling, is provided to expedite wound healing.

### Conditions Module

**Conditions:**

- Chronic Wounds

**Keywords:**

- VSD drainage surgery

- systematic psychological intervention

- chronic wounds

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- CARE_PROVIDER

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The patients in the intervention group received systematic psychological intervention on the basis of routine nursing after admission, the main steps were as follows: 1 preoperative and postoperative psychological assessment (self-rating anxiety scale (SAS) and self-rating depression scale (SDS-RRB- to assess the psychological status of patients) , this part through medical records, face-to-fAssessmentment and questionnaire survey; Timely attention to patients' psychological state. 2 at the end of the evaluation, we can start the psychological intervention, collect the pre-intervention scale and post-intervention scale, collect the data, and make records according to the collected data, so as to carry on the follow-up work in the later period. 3 the days of hospitalization, the satisfaction of hospitalization, the expenses of hospitalization and the psychological scale were recorded, and the influence of psychological intervention on the patients was compared with the routine group.

**Intervention Names:**

- Behavioral: Psychological Intervention Group

**Label:** Psychological Intervention Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Routine nursing care is carried out by the regular group based on the measures for VSD drainage procedure.

**Label:** Routine care group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Psychological Intervention Group

**Description:** The intervention group provides psychological education to patients, emphasizing participation in a "Surgery Success" patient group organized by researchers, and collects successful patient cases for promotion. Patients are encouraged to learn from successful cases within the group. Psychological intervention is also provided to family members, as they are the primary caregivers, and guiding their thoughts is crucial. Timely identification of patients with psychological abnormalities is conducted, with psychological consultations if necessary. Targeted measures are taken for patients with psychological abnormalities. Upon discharge, one-on-one consultation and tracking services are provided by designated nurses to alleviate patients' feelings of helplessness and despair, continuing until the patient fully recovers.

**Name:** Psychological Intervention Group

**Other Names:**

- Experimental group

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The Self-Rating Anxiety Scale (SAS) was developed by W.K. Zung in 1971. This scale consists of 20 items reflecting subjective feelings of anxiety, with each item rated on a four-point scale based on the frequency of symptoms. The scoring criteria are as follows: "1" indicates none or very little time; "2" indicates some of the time; "3" indicates a good part of the time; "4" indicates most or all of the time.According to normative results, in China, the standard deviation cutoff for SAS is 53 points. The divisions are as follows:53 to 62 points: Mild anxiety，63 to 72 points: Moderate anxiety，Above 72 points: Severe anxiety.

**Measure:** Self-rating anxiety scale (SAS)

**Time Frame:** After 4 weeks of intervention

**Description:** The Self-Rating Depression Scale (SDS) was developed by W.K. Zung in 1965. This scale comprises 20 items reflecting subjective feelings of depression, with each item rated on a four-point scale based on the frequency of symptoms. For positively scored items, the ratings are 1, 2, 3, 4 respectively, while for negatively scored items, they are 4, 3, 2, 1. The normal upper limit for the total raw score of SDS is 41 points, with lower scores indicating better states. The standard score is obtained by multiplying the total raw score by 1.25 and taking the integer part. The standard deviation cutoff for SDS is 53 points. The divisions are as follows:53 to 62points:Mild depression，63 to 72 points: Moderate depression，Above 73 points: Severe depression.

**Measure:** self-rating depression scale (SDS）

**Time Frame:** After 4 weeks of intervention

#### Secondary Outcomes

**Description:** The satisfaction was calculated using our hospital's unified discharge satisfaction questionnaire for inpatients. Each item is rated on a scale of 1 to 5, with a total of 20 items and a maximum score of 100 points. Scores above 95 are considered satisfied, scores between 90 and 95 are deemed basically satisfied, and scores below 90 indicate dissatisfaction.

**Measure:** Patient satisfaction with hospitalization

**Time Frame:** After 4 weeks of intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

- A mentally healthy, communicative adult. Patients and their families are cooperative, understanding, and supportive of this study.

Adult patients undergoing VSD surgery for chronic wounds.

Exclusion Criteria:

- Patients who are unable to effectively cooperate with nursing questionnaires due to auditory or visual impairments, cognitive impairments, or low levels of cultural literacy.

Patients with poor compliance or those who harbor skepticism and hostility towards this research.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: HIGH

- As Found: Wound

- ID: M17684

- Name: Wound Infection

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014947

- Term: Wounds and Injuries

### Misc Info Module

- Version Holder: 2024-05-31
