The impact of humanistic care nursing intervention on the negative emotions of patients undergoing radical surgery for perianal abscess: A randomized controlled trial
| ISRCTN | ISRCTN36050120 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36050120 |
| Sponsor | Weifang People's Hospital Colorectal and Anorectal Surgery Department |
| Funder | Huainan City Science and Technology Project (2025056) |
- Submission date
- 27/01/2026
- Registration date
- 27/03/2026
- Last edited
- 24/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Lirong Fang
Scientific, Public, Principal investigator
Scientific, Public, Principal investigator
No. 203, Huibin Road, Tianjia'an District
Huainan
232007
China
| Phone | +86 18098687117 |
|---|---|
| 774018770@qq.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Supportive care |
| Scientific title | The impact of humanistic care nursing intervention on the negative emotions of patients undergoing radical surgery for perianal abscess: A randomized controlled trial |
| Study objectives | Patients undergoing surgery for perianal abscesses |
| Ethics approval(s) |
Approved 03/09/2025, The First Hospital of Anhui University of Science and Technology (Huainan City, Anhui Province, Huainan, 232007, China; +86 18098687117; 774018770@qq.com), ref: 2025-KY-Y053-001 |
| Health condition(s) or problem(s) studied | Negative emotions of patients undergoing radical surgery for perianal abscess |
| Intervention | Control group: The control group received routine operating room nursing care. ① Preoperative care: Monitoring vital signs, performing blood tests, and coagulation function tests; informing patients of the surgery time, anesthesia method, and preoperative precautions (such as fasting, fluid restriction, and bowel preparation); providing routine preoperative health education, including disease-related knowledge, basic surgical procedures, and postoperative rehabilitation points. ② Intraoperative care: Assisting patients with positioning during surgery, closely monitoring vital signs (heart rate, blood pressure, blood oxygen saturation, etc.), and cooperating with surgeons to complete instrument transfers and other procedures to ensure a smooth surgery. Postoperative care: Guiding patients on dietary adjustments (e.g., initially consuming liquids, gradually transitioning to semi-liquids and then regular foods, avoiding spicy and irritating foods); informing patients of postoperative bowel movement precautions; administering anti-infective and analgesic medications as prescribed, and observing for adverse drug reactions. Observation Group: The day before surgery, the circulating nurse from the operating room made a one-on-one ward visit. They brought a diagram of the operating room environment and explained the layout and equipment usage in simple terms; demonstrated the intraoperative positioning procedure, and emphasized privacy protection and channels for reporting discomfort. The ward nurse played a short video of a patient's postoperative recovery, with consent, including their experience during surgery and the nurse's assistance. This thorough communication with the patient, through individualized preoperative health education, avoided excessive speculation and fear caused by information asymmetry, alleviating anxiety at its source. On the day of surgery, the circulating nurse entered the ward for preoperative handover: the operating room specialist nurse and the ward nurse jointly verified the patient's information. The patient was informed that they would be accompanied throughout the surgery and escorted back to their ward. During transport, divert the patient's attention with lighthearted topics, avoiding words related to surgical difficulty and risks. On the day of surgery, preoperative preparation: Adjust the operating room temperature to 22-25℃ and humidity to 50%-60%, and play soft background music. Gently position the patient in a side-lying position, explaining each step of the procedure in advance. Place soft pillows under pressure points such as the armpits and shoulders, and add cotton padding to the ankle restraints. Prioritize privacy, covering the patient's upper body and lower limbs, exposing only the perianal area. On the day of surgery, intraoperative cooperation: Hold the patient's hand and gently explain the surgical progress and channels for reporting discomfort. If the patient shows signs of tension such as closing their eyes or trembling, gently pat their shoulder and silently accompany them. Instruct the patient on how to relax. Postoperative transport and handover: Clean the patient of disinfectant and bloodstains, change into clean, sterile sheets, and transport them slowly. Lay the limbs flat to avoid dizziness caused by sudden changes in position. Inform the patient that the surgery was successful, keep them warm with a warm blanket during transport, and inquire about their physical sensations. Upon returning to the ward, hand over the patient to the responsible nurse, emphasizing the patient's emotional state and positional tolerance during the operation. Postoperative rehabilitation guidance and pain management: Create and distribute a graphic rehabilitation manual, noting postoperative bowel movements, wound protection, and the time required for normal activity recovery, providing daily on-site guidance. Explain the physiological nature of postoperative pain to the patient and guide them to develop a positive coping mindset. Instruct the patient to adopt a supine or unaffected side-lying position, with a soft pillow between the knees for comfort. Instruct the patient on non-pharmacological pain relief methods such as warm water sitz baths and acupressure massage. Administer analgesics according to the doctor's orders, based on the pain score and individual tolerance, and observe the pain relief effect and adverse drug reactions. Follow-up Total duration of treatment and follow-up for all study groups: from admission to discharge. Randomisation process This study adopted the principles of randomization and double-blindness. The grouping allocation plan and the study numbers were sealed in opaque envelopes by nursing staff who were not involved in the study design. After the patients entered the operating room, the nursing staff would open the envelopes and prepare the intervention measures-related drugs and plans according to the grouping requirements. The implementers of perioperative intervention and the evaluators of the effect were all unaware of the grouping situation. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 18/03/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 17 Years |
| Upper age limit | 82 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | 1. Patients diagnosed with perianal abscess through clinical symptoms, signs, imaging (such as ultrasound) or laboratory tests, and scheduled for radical surgery for perianal abscess 2. Age between 17 and 82 years old, with clear consciousness, normal language communication ability and reading/writing skills, and able to cooperate with the completion of scale assessment and nursing intervention 3. Voluntarily participating in this study and able to ensure the completion of the entire research period (from preoperative to the end of postoperative follow-up). |
| Key exclusion criteria | 1. Patients with severe functional failure of important organs such as the heart, liver, and kidneys, or suffering from malignant tumors, coagulation disorders, etc. that may affect the surgical prognosis and emotional assessment 2. Patients with a previous history of mental illness (such as schizophrenia, bipolar disorder, etc.) or cognitive dysfunction (such as dementia) 3. Patients who cannot cooperate with the preoperative assessment, intraoperative/postoperative nursing intervention and follow-up due to personal reasons (such as planning to transfer after surgery) |
| Date of first enrolment | 03/09/2025 |
| Date of final enrolment | 18/03/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
10/03/2026: Trial's existence confirmed by First Affiliated Hospital of Anhui University of Science and Technology.
