Study design and participants
The current study is a single-center randomized controlled trial following CONSORT 2010 clinical trial guidelines11 to explore the role of pain diary in pain management during hospitalization for PHN patients.
This study was managed and supervised by the Ethics Committee of the Affiliated Hospital of Southwest Medical University (KY2019073) and the protocol of this study was registered at the Chinese Clinical Trial Registry (www.chictr.org.cn) on 07/03/2020 (Registration number: ChiCTR2000030565).The protocol of current study can be seen at supplementary material (Supplementary.1). All participants signed informed consent, and was diagnosed with PHN, aged 18-70 years, patients with clear intelligence and correct writing were included in this study. Patients with PHN less than 10 days in hospital and baseline VAS pain scores less than 3 were excluded.
Since there is no data on pain diary in the pain management of PHN patients, the sample size calculation is based on a previous cancer-related pain study. The pain score in the pain diary and the control group was 2.76 (SD = 1.64) and 2.15 (SD = 1.67). The sample size ratio was 1: 1, α error 0.05 and β error 0.2, and effect size 36%. Considering that the subjects were hospitalized patients, we set the lost follow-up rate to 5%. The final calculation required 59 people per group.
Prior to randomization, all patients were interviewed to record VAS scores to determine baseline pain levels, assess the location and nature of pain, and record demographic characteristics. For patients who met the inclusion criteria, after signing the informed consent, they were randomly divided into the diary group and the control group using computer-generated random numbers. Diary group and control group patients are allocated in different wards to avoid interference. As it involves the guidance of patients in the diary group, the blind method cannot be adopted in this study. However, the final data collection and statistical analysis are performed by people who do not know the grouping situation.
All patients were instructed on admission how to describe their pain on a scale of 0 to 10, with 0 being painless and 10 being excruciatingly painful. Trained pain nurses conducted daily dynamic self-assessment of pain in the diary group and kept a pain diary, mainly recording the cause, degree and relief of pain, whether to seek help and some questions about pain treatment (Table.1). Patients in the diary group were interviewed the first two days to ensure that they understood the correct self-assessment of pain and kept a pain diary. Patients were told not to keep a diary when they need urgent help and to call a nurse or doctor immediately. Patients in the control group received routine pain care and were asked about their disease information during the daily ward rounds.
After receiving the pain diary, the nurses proceeded according to the SBAR model. Establish a uniform transfer system between doctors and nurses, and describe patient conditions and problems in a unified and standardized manner. The nurse extracts pain diary information, conducts a preliminary assessment of current problems, and distinguishes between problems that nursing can solve and problems that need to be addressed by a doctor. After processing the patient's needs in a timely manner, the information is fed back to the doctor in accordance with the SBAR communication method, and the doctor is adjusted to the treatment.
The basic information of the enrollees of this trial was collected by the nurses in the inpatient department before randomization, including the patient's gender, age, baseline pain level, pain site, education level. The average daily pain level of the patients, the completion of the Thai-BPI questionnaire and the patient satisfaction survey were completed by a third-party hospital researcher. The trial group assigned them to hide. When assessing pain levels daily, patients were invited to interview rooms individually. The evaluators explained to them the VAS standard and how to describe the degree of pain, and then the patients reported their pain levels for the past day on their own. This assessment was performed only once a day. The third-party evaluator invited the patient to fill in the Thai-BPI questionnaire on the fifth day after the patient was admitted to the hospital. The information extraction of pain diary is performed by trained nurses. They collect the patient's pain diary every day and carefully read the extracted diary information to record the disease information and pain information fed back by the patient. And all the data was filled in using an electronic form. The data was stored in the clinic of the hospital. Research database.
Daily pain level. VAS score was used to assess the pain level of patients in both groups during daily ward rounds (as described above) for 10 consecutive days. Determine the patient's overall pain on a daily basis.
Thai-BPI. The Thai-BP questionnaire is an assessment tool for assessing the pain and physical condition of patients12, which can reflect the pain of patients for a period of time. It can assess the intensity of pain in patients with the most severe pain, the slightest pain, and general pain. In addition, it also includes a 24-hour average pain intensity, with pain levels ranging from 0 to 10; 0 means no pain and 10 means unbearable pain. There are 13 entries, each with a score of 10 points. The higher the score, the worse the situation. We only selected 10 entries that are closely related to our research. Patients were invited to a Thai-BP questionnaire interview at mid-term.
Number of patient's condition information.Pain diaries for patients in the diary group were organized by the nursing staff each day, and the patient's feedback information includes the cause, extent, remission, and treatment effect of pain were recorded. In addition, the condition information reported by the two groups during the morning round were recorded. If the questions obtained during the rounds are similar to those in the diary, they are removed and recorded as only one information. At any time, the condition information that the patient reports directly to the attending doctor or nurse will also be recorded, and the recording principle is the same as before. Finally calculate the total number of information for each patient within 10 days.
Patient satisfaction. On the 10th day, the patient's satisfaction with the nurses and doctors was evaluated. On a scale of 0 to 10, 0 was bad and dissatisfied, and 10 was most satisfied. Patients included need to be evaluated separately for nurses and attending physicians. In addition, in the interview on the last day, the patients in the diary group were asked if the pain diary was good for their pain, and the patients could answer that it was very beneficial, with some benefits and no benefits.
Data entry and sorting are done in Microsoft Excel-2016 software; Data analysis was performed using IBM SPSS version 24.0. Quantitative data conforming to the normal distribution are expressed by mean and standard deviation, and non-normal distribution data are expressed by interquartile range. For the comparison of qualitative data such as demographic characteristics, the chi-square test and Fisher exact probability method were used for statistical description; Comparison of pain scores within the group was performed using one-way analysis of variance (ANOVA); Comparison of pain scores between groups, Thai-BPI scores of the two groups of patients, number of patient's condition information, and satisfaction comparison were performed using Student's t test. Statistical result P <0.05 indicates that the difference is statistically significant.