NCT06424561

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

May 3, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

May 3, 2024

Last Update Submit

February 14, 2025

Conditions

Keywords

VSD drainage surgerysystematic psychological interventionchronic wounds

Outcome Measures

Primary Outcomes (2)

  • Self-rating anxiety scale (SAS)

    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.

    After 4 weeks of intervention

  • self-rating depression scale (SDS)

    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.

    After 4 weeks of intervention

Secondary Outcomes (1)

  • Patient satisfaction with hospitalization

    After 4 weeks of intervention

Study Arms (2)

Psychological Intervention Group

EXPERIMENTAL

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.

Behavioral: Psychological Intervention Group

Routine care group

NO INTERVENTION

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

Interventions

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.

Also known as: Experimental group
Psychological Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 22, 2024

Study Start

December 2, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations