Perioperative self-care ability in patients with acute stroke
| ISRCTN | ISRCTN12931409 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12931409 |
- Submission date
- 27/10/2025
- Registration date
- 29/10/2025
- Last edited
- 28/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study looks at how a more detailed and personalised type of nursing care—called meticulous or fine nursing—might help people recovering from a stroke take better care of themselves. Stroke can affect movement, speech, and independence, so improving self-care ability is an important part of recovery. Researchers wanted to see if this extra level of nursing support could make a difference compared to standard care.
Who can participate?
People who were diagnosed with stroke and admitted to hospital for treatment—either clot-busting therapy or surgery to remove bleeding—were invited to take part. To be included, patients needed to be stable after surgery, have normal vital signs, be awake and able to communicate clearly.
What does the study involve?
100 patients were randomly split into two groups. One group received regular nursing care, while the other group received regular care plus extra support through meticulous nursing. Researchers collected information before and after the care period, including stroke severity, quality of life, ability to walk, and how well patients could care for themselves.
What are the possible benefits and risks of participating?
Participants may benefit from improved recovery and greater independence if the extra nursing care proves helpful. There were no specific risks mentioned, as all care provided was within normal hospital standards and safety procedures.
Where is the study run from?
Tianjin Fifth Central Hospital in China.
When is the study starting and how long is it expected to run for?
June 2024 to December 2025
Who is funding the study?
Funding came from two sources: the National Key Clinical Specialty Emergency Medicine Department Construction Project and the Tianjin Key Medical Development Discipline for Emergency Medicine.
Who is the main contact?
Dr Yan Yang, yangy2025yyan@163.com
Contact information
Public, Scientific, Principal investigator
No. 41 Zhejiang Road, Tanggu, Binhai New Area
Tianjin City
300450
China
| Phone | +86 18698059362 |
|---|---|
| yangy2025yyan@163.com |
Study information
| Study design | Interventional randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| Scientific title | The impact of fine nursing intervention on perioperative self-care ability in patients with acute stroke |
| Study objectives | To explore the effect of meticulous nursing intervention on self-care ability of patients with acute stroke |
| Ethics approval(s) |
Approved 27/08/2025, The ethics committee of Tianjin Fifth Central Hospital (No. 41 Zhejiang Road, Tanggu, Binhai New Area, Tianjin City, 300450, China; +86 022-65665880; wzxyyll@163.com), ref: WZX-EC-KY2025032 |
| Health condition(s) or problem(s) studied | Nursing methods for patients with acute stroke |
| Intervention | This prospective cohort study enrolled 100 stroke patients admitted to our hospital from June 2024 to December 2024 through convenience sampling. Participants were randomly allocated into a control group and an intervention group (50 cases each) using a random number table method. The control group received conventional perioperative interventions, including establishing intravenous access for administering medications such as intracranial pressure-reducing agents, diuretics, antibiotics, and neurotrophic drugs. The nursing team assisted patients in completing necessary examinations, including lipid profiles, blood pressure monitoring, and imaging studies. Preoperatively, vital signs (respiratory rate, heart rate, blood pressure, and body temperature) were closely monitored, with verification of medication and instrument availability in the operating room. Ambient temperature was maintained at 27-30°C. Intraoperative vital sign monitoring continued consistently. Postoperatively, routine health education was provided, covering dietary guidance, sleep hygiene, and exercise recommendations. The intervention group received fine nursing combined with clinical nursing pathway interventions in addition to the standard care provided to the control group. (1) establishment of an FN team: A core FN team comprising one head nurse and four staff nurses was organized. The team conducted specialized meetings to clarify the objectives and requirements of FN, develop optimized protocols with detailed implementation methods, and establish standardized nursing procedures. (2) fine health education: Designated nurses provided comprehensive patient education regarding treatment plans, potential complications, preventive measures, and emphasized the importance of rehabilitation training along with specific methodologies. (3) fine psychological intervention: The nursing team assessed patients' psychological status and closely monitored emotional fluctuations. For patients exhibiting negative emotions, immediate psychological counseling was provided. Regular patient support groups were organized, utilizing psychological intervention videos, case analyses, and testimonials from recovered patients to demonstrate the importance of positive mental health for rehabilitation. Family members were encouraged to provide emotional support, with recommendations such as playing soothing music to alleviate distress and foster a positive disease-coping mindset. Each fine psychological intervention session lasted 20 minutes, administered twice weekly. (4) joint-muscle rehabilitation: For medically stable patients, nurses developed early accelerated rehabilitation plans. This included positioning the affected limb functionally, placing a soft pillow under the calf to maintain 35°knee flexion, and guiding patients through ankle circumduction, dorsiflexion, and toe extension-flexion exercises (5-10s contraction, 5-8s relaxation, repeated cycles). This regimen was performed 4 times daily (10-15min/session). After 30-40 minutes rest, muscle contraction training was initiated: patients in supine position performed ankle dorsiflexion and knee extension (5-10s hold), followed by medial thigh muscle contractions (verified by patellar movement, 8-10s hold). This cyclic training lasted 15-25 minutes, 3-4 times daily, continuing for 1-2 weeks. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Demographic characteristics are measured using patient interviews and hospital records at baseline 2. Surgical parameters are measured using operative reports and hospital records at baseline 3. Neurological impairment is measured using the National Institutes of Health Stroke Scale (NIHSS) at baseline and postoperative day 6 4. Quality of life is measured using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) at baseline and 2 weeks postoperatively 5. Lower extremity motor function is measured using the Fugl-Meyer Assessment (FMA) for lower extremities at baseline and postoperative day 6 6. Ambulation ability is measured using the Functional Ambulation Category (FAC) scale at baseline and postoperative day 6 |
| Secondary outcome measures | Self-care agency is measured using the Exercise of Self-Care Agency (ESCA) scale at baseline and 2 weeks postoperatively |
| Overall study start date | 01/06/2024 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 50 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Meeting the diagnostic criteria for stroke according to clinical guidelines 2. Hospitalized patients scheduled for stroke surgery (thrombolysis or hematoma evacuation) at our institution 3. Postoperative stable condition with normal vital signs 4. Clear consciousness and normal verbal communication postoperatively |
| Key exclusion criteria | 1. Psychiatric disorders 2. Cognitive impairment 3. Severe cardiac, hepatic, or renal insufficiency or malignant tumors |
| Date of first enrolment | 01/06/2024 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Tianjin City
300450
China
Sponsor information
Hospital/treatment centre
No. 41 Zhejiang Road, Tanggu, Binhai New Area
Tianjin City
300450
China
| Phone | +86 18698059362 |
|---|---|
| shixx88xx@21cn.com | |
| Website | http://www.tjwzx.cn/ |
"ROR" |
https://ror.org/01924nm42 |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 01/11/2025 |
|---|---|
| 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 | All data generated or analysed during this study are included in this article. Further enquiries can be directed to the corresponding author (Yan Yang Email:yangy2025yyan@163.com). |
Editorial Notes
27/10/2025: Trial's existence confirmed by the ethics committee of Tianjin Fifth Central Hospital.
