Research on the application of continuous nursing in postoperative rehabilitation of patients with lower extremity varicose veins
| ISRCTN | ISRCTN13537163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13537163 |
- Submission date
- 24/10/2024
- Registration date
- 13/11/2024
- Last edited
- 12/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This study aims to investigate the effectiveness of a continuous nursing model in the postoperative rehabilitation of patients with lower extremity varicose veins.
Who can participate?
Patients diagnosed with lower extremity varicose veins who are undergoing surgical treatment, aged between 18 and 75 years old
What does the study involve?
A control group will receive standard postoperative care, and an experimental group will receive a continuous nursing intervention. The control group's care includes routine wound care, standard discharge instructions, and follow-up appointments as per hospital protocol.
What are the possible benefits and risks of participating?
Implementing a continuous nursing model may enhance the postoperative rehabilitation and overall well-being of patients with lower extremity varicose veins.
No risk factors.
Where is the study run from?
Vascular Surgery, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences
When is the study starting and how long is it expected to run for?
January 2023 to December 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Junxia Du, dujunxia2024djx@126.com
Contact information
Public, Scientific, Principal Investigator
Shanxi Academy of Medical Sciences, No. 99 Longcheng Street, Longcheng Street, Xiaodian District
Taiyuan
030032
China
 ORCID ID |
0009-0008-6603-8593 |
|---|---|
| Phone | +86 15234049172 |
| dujunxia2024djx@126.com |
Study information
| Study design | Single-center interventional double-blind randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital, Medical and other records, Telephone |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Research on the application of continuous nursing model in postoperative rehabilitation of patients with lower extremity varicose veins |
| Study objectives | Implementing a continuous nursing model may significantly enhance the postoperative rehabilitation and overall well-being of patients with lower extremity varicose veins. |
| Ethics approval(s) |
Approved 10/04/2024, Ethics Committee of Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences (No. 99 Longcheng Street, Longcheng Street, Xiaodian District, Taiyuan, 030032, China; 8603518379145; dyyllwyh@163.com), ref: YXLL-2024-076 |
| Health condition(s) or problem(s) studied | Lower extremity varicose veins |
| Intervention | A total of 120 patients meeting the inclusion criteria were recruited for the study. Sample size calculation was based on previous studies, assuming a medium effect size with a power of 0.80 and a significance level of 0.05. Participants were randomly assigned to either the control group (n=60) or the experimental group (n=60) using a computer-generated randomization sequence. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes. The control group received standard postoperative care, and the experimental group received a continuous nursing intervention. The control group's care included routine wound care, standard discharge instructions, and follow-up appointments as per hospital protocol. The experimental group received a comprehensive intervention comprising five key components: 1. Pre-discharge education covering recovery information, wound care techniques, and activity guidelines 2. A home-based care plan featuring personalized exercise regimens, dietary recommendations, and compression therapy guidance 3. Scheduled follow-ups including weekly telephone consultations and bi-weekly home visits for the first month, followed by monthly visits for two months, plus 24/7 hotline access 4. Psychological support with regular mental health assessments and provision of coping strategies 5. Lifestyle modification guidance for long-term recurrence prevention and occupational adaptations, if necessary |
| Intervention type | Mixed |
| Primary outcome measure | 1. Wound healing time (in days) measured using data recorded in patient medical notes after surgery 2. Lower extremity function was measured using the Lower Extremity Functional Scale (LEFS) scores at 1, 3, and 6 months post-surgery 3. Pain was measured using the Visual Analog Scale (VAS) at 1 month post-surgery 4. Walking distance (in meters) measured using the standardized 6-minute walk test (6MWT) conducted in a 30-meter indoor corridor at 1-month post-surgery. Patients walked at their self-selected pace for 6 minutes with the total distance recorded. 5. Quality of life measured using the Short Form-36 (SF-36) questionnaire scores at 6 months post-surgery |
| Secondary outcome measures | 1. Psychological status, measured using Beck Depression Inventory (BDI) scoring and Self-Rating Anxiety Scale (SAS) scoring at 6 months post-surgery 2. Activities of daily living measured using Activities of Daily Living (ADL) at 1, 3, and 6 months post-surgery |
| Overall study start date | 06/01/2023 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Patients diagnosed with lower extremity varicose veins who are undergoing surgical treatment 2. Aged between 18 and 75 years 3. Willing and able to provide informed consent |
| Key exclusion criteria | 1. Presence of severe comorbidities (such as uncontrolled diabetes or severe cardiovascular disease) 2. Cognitive impairments that could interfere with following postoperative instructions 3. Participation in other clinical trials 4. Pregnancy or breastfeeding |
| Date of first enrolment | 20/01/2023 |
| Date of final enrolment | 10/12/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Taiyuan
030032
China
Sponsor information
Hospital/treatment centre
Shanxi Bethune Hospital, No. 99 Longcheng Street, Longcheng Street, Xiaodian District
Taiyuan
030032
China
| Phone | +86 0351 8368114 |
|---|---|
| sxyxkxyyljd@163.com | |
| Website | https://m.sxbqeh.com.cn/entry |
"ROR" |
https://ror.org/04tshhm50 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data that support the findings of this study are available from the corresponding author upon reasonable request, Junxia Du, dujunxia2024djx@126.com. |
Editorial Notes
12/11/2024: Study's existence confirmed by the Ethics Committee of Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences. The PI stated that ethics approval was delayed which is why the recruitment started before the official approval date.
