Chronic WoundsNCT06424561
The Influence of Systematic Psychological Intervention on Patients About VSD Drainage Surgery
A study testing Psychological Intervention Group in people with Chronic Wounds, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- Psychological Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
wenying wu, +86 0579-89935052, jigoulunli_zy4y@163.com
About this study
Official title: The Influence of Systematic Psychological Intervention on Patients Undergoing VSD Drainage Surgery for Chronic Infected Wounds
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.
Read the 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
- Chronic Wounds
- Being tested
- Psychological Intervention Group
- Keywords
- VSD drainage surgery, systematic psychological intervention, chronic wounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Intervention GroupBehavioural
Also called Experimental 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 4 weeks of intervention
Secondary outcomes (1)
Patient satisfaction with hospitalization
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.
Measured: After 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start2 Dec 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424561
- Sponsor's protocol ID
- KY-2024-085
- Status last verified
- Feb 2025
- First submitted
- 3 May 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Systematic Psychological Intervention on Patients Undergoing VSD Drainage Surgery for Chronic Infected Wounds
- ClinicalTrials.gov ID
- NCT06424561
- Acronym / sponsor ID
- KY-2024-085
- Conditions
- Chronic Wounds
- Keywords
- VSD drainage surgery, systematic psychological intervention, chronic wounds
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological Intervention Group | Experimental | Behavioral: Psychological Intervention GroupThe 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 intervention | –Routine nursing care is carried out by the regular group based on the measures for VSD drainage procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Intervention GroupAlso: Experimental groupThe 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. | Behavioural | Psychological Intervention Group |
Primary outcome
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.
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.
1 secondary outcome
Patient satisfaction with hospitalization
Time frame: After 4 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Intervention Group in people with Chronic Wounds, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-rating anxiety scale (SAS) (time frame: After 4 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.