- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06424561
The Influence of Systematic Psychological Intervention on Patients About VSD Drainage Surgery
The Influence of Systematic Psychological Intervention on Patients Undergoing VSD Drainage Surgery for Chronic Infected Wounds
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Yiwu, Zhejiang, China, 322000
- Recruiting
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
-
Contact:
- wenying wu
- Phone Number: +86 0579-89935052
- Email: jigoulunli_zy4y@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychological Intervention Group
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.
|
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.
Other Names:
|
|
No Intervention: Routine care group
Routine nursing care is carried out by the regular group based on the measures for VSD drainage procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-rating anxiety scale (SAS)
Time Frame: After 4 weeks of intervention
|
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)
Time Frame: After 4 weeks of intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction with hospitalization
Time Frame: After 4 weeks of intervention
|
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.
|
After 4 weeks of intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-2024-085
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Wounds
-
PEMF Systems, Inc.Southern California Institute for Research and Education; VA Long Beach Healthcare...Not yet recruitingChronic Wounds
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
University Hospital, LillePixacareNot yet recruiting
-
SerenaGroup, Inc.MDM Wound Ventures, LLCCompletedChronic Wounds | Acute WoundsUnited States
-
Woundchek Laboratories BVInnovate UK; Pennine Care NHS Foundation Trust; Greater Manchester Academic Health...Completed
-
SerenaGroup, Inc.Anacapa Technologies IncCompleted
-
Lohmann & RauscherRecruitingAcute and Chronic WoundsGermany
-
StimLabsActive, not recruitingChronic Wounds | Diabetic UlcersUnited States
-
Smith & Nephew, Inc.CompletedChronic WoundsUnited Kingdom
-
University Hospital Center of MartiniqueNot yet recruitingChronic WoundsMartinique
Clinical Trials on Psychological Intervention Group
-
University of PadovaRecruitingLoneliness | Psychological Well Being | Social RelationshipItaly
-
The University of The West IndiesTerminatedQuality of Life | Self Efficacy | Self-stigmaBarbados
-
Children's Hospital of PhiladelphiaCompleted
-
Universidad de CórdobaMinisterio de Economía y Competitividad, SpainCompletedDepression | Anxiety Disorders | Somatoform Disorders | Common Mental DisordersSpain
-
Odense University HospitalCenter for Digital PsykiatriRecruitingDiabetes Mellitus, Type 1 | Diabetes DistressDenmark
-
Ruhr University of BochumCompletedPsychological Distress | Psychology, PositiveGermany
-
Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology... and other collaboratorsRecruitingIntermittent Claudication | Peripheral Arterial Disease (PAD)Portugal
-
Cairo UniversityCompletedPublic Health | Somatic Disorders | PsychologicEgypt
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedBlood Pressure | Psychological StressUnited States
-
Guangxi Medical UniversityCompletedBurnout | PsychologicalChina