The Influence of Systematic Psychological Intervention on Patients About VSD Drainage Surgery
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2024
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
May 3, 2024
CompletedFirst Posted
Study publicly available on registry
May 22, 2024
CompletedStudy Start
First participant enrolled
December 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 17, 2025
February 1, 2025
1.9 years
May 3, 2024
February 14, 2025
Conditions
Keywords
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
EXPERIMENTALThe 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.
Routine care group
NO INTERVENTIONRoutine 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.
Eligibility Criteria
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
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