Impact of graded nursing interventions based on quantitative risk assessment on psychological stress responses in patients undergoing resection for primary liver cancer
| ISRCTN | ISRCTN81587743 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81587743 |
- Submission date
- 18/04/2025
- Registration date
- 25/04/2025
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Liver cancer is one of the malignancies with high incidence and mortality rates worldwide. This study aims to explore the impact of quantitative graded nursing interventions on psychological stress and postoperative recovery in patients undergoing primary liver cancer resection by constructing a grading assessment system centered on Child-Pugh scores and HAMA/HAMD scales, combined with dynamic nursing resource allocation.
Who can participate?
Patients preparing for liver cancer surgery.
What does the study involve?
Health education and nursing before and after liver cancer surgery.
What are the possible benefits and risks of participating?
Helps liver cancer patients recover after surgery. No potential risks.
Where is the study run from?
The study was conducted at the First Affiliated Hospital of Ningbo University (China)
When is the study starting and how long is it expected to run for?
January 2023 to February 2024
Who is funding the study?
Provincial Medical Project (No.2025KY249) (China)
Who is the main contact?
Dr Qinhong Xu, xuqinhong_xqh03@126.com
Contact information
Public, Scientific, Principal Investigator
59 Liu Ting Street, Haishu District
Ningbo
315000
China
 ORCID ID |
0009-0008-8726-2439 |
|---|---|
| Phone | +86 0574 87085014 |
| xuqinhong_xqh03@126.com |
Study information
| Study design | Single-center interventional double-blind randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | The impact of graded nursing interventions based on quantitative risk assessment on psychological stress responses in patients undergoing resection for primary liver cancer |
| Study objectives | Graded nursing interventions based on quantitative assessment may reduce postoperative psychological stress levels and negative emotions in patients undergoing primary liver cancer surgery, promoting postoperative recovery |
| Ethics approval(s) |
Approved 13/07/2023, Ethics Committee of The First Affiliated Hospital of Ningbo University (59 Liu Ting Street, Haishu District, Ningbo, 315000, China; +86 0574 87085233; sychenjy@163.com), ref: 2023Y-095RS |
| Health condition(s) or problem(s) studied | Nursing care for patients undergoing resection of primary hepatic cancer |
| Intervention | Random number sequences are generated using SPSS 26.0, stratified by Child-Pugh score (A/B grade), with a block size of 4 for each stratum. Sealed opaque envelopes are used to store allocation results, managed by an independent statistician. After enrollment, research nurses assign patients to groups according to the envelope instructions, dividing them into an observation group and a control group, each with 40 patients. The control group receive routine nursing care, which included: Preoperative health education: Nursing staff provided patients with knowledge about liver cancer through oral communication; Postoperative pain management (VAS score ≤ 3): Close monitoring of patients' pain, bowel movements, and drainage tube conditions after surgery; Early ambulation (within 24 hours postoperatively): Guidance on early ambulation to actively prevent complications. A targeted assessment of the condition of enrolled liver cancer patients is conducted. Treatment risk was categorized based on the comprehensive score: low risk medium risk and high risk. Based on the quantitative assessment results, clinical nursing staff from various departments were allocated appropriately, and stratified nursing measures were implemented. Low-risk patients: Assigned N0–N1 nursing staff to provide routine ERAS care + psychological support (10 minutes of mindfulness training daily). Medium-risk patients: Assigned N2 or higher nursing staff to implement low-risk measures + personalized exercise plans (bed activities starting 6 hours postoperatively). High-risk patients: Assigned N3 or higher nursing staff, team leaders, or specialist nurses to implement medium-risk measures + multidisciplinary team interventions (joint daily rounds by psychiatric nurses and nutritionists) . |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Psychological stress response is measured using Psychological Stress Response Questionnaire (SRQ) at one day before surgery, three days after surgery , and at discharge. 2. Depressive state is measured using Hamilton Depression Scale (HAMD) at one day before surgery, three days after surgery , and at discharge. 3. Anxiety level is measured using Hamilton Anxiety Scale (HAMA) at one day before surgery, three days after surgery , and at discharge. |
| Secondary outcome measures | Measured using patient records: 1. Recorded the time to tolerate semi-liquid diet (time from surgery to first intake of ≥200 mL semi-liquid food) 2. Time to first out-of-bed activity (time from surgery to independent standing and walking ≥5 meters) 3. Time to first postoperative anal exhaust, and length of hospital stay |
| Overall study start date | 05/01/2023 |
| Completion date | 06/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 80 |
| Key inclusion criteria | 1. Meeting the surgical indications outlined in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)" (single tumor diameter ≤ 5 cm, no portal vein trunk tumor thrombus, Child-Pugh A/B grade) 2. Age 18-75 years 3. Signed informed consent |
| Key exclusion criteria | 1. Severe cardiovascular disease (NYHA III-IV grade) 2. Immune system disease or coagulation dysfunction (INR > 1.5, PLT < 50 × 10^9/L) 3. Malignant tumors in other locations 4. History of cognitive impairment or mental illness. |
| Date of first enrolment | 06/01/2023 |
| Date of final enrolment | 31/12/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Ningbo
315000
China
Sponsor information
Hospital/treatment centre
59 Liu Ting Street, Haishu District
Ningbo
315000
China
| Phone | +86 0574 87085146 |
|---|---|
| dyyygcp@163.com |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to privacy and ethical restrictions. |
Editorial Notes
22/04/2025: Trial's existence confirmed by Ethics Committee of The First Affiliated Hospital of Ningbo University.
