Primary outcomes are nursing workload and the satisfaction of patients, family members, doctors and nurses. These will be measured as following:
(1) To assess the nursing workload, working hours of nurses spent on the admission guidance in the first 24 hours of admission, and which include the time spent on guidance and addressing the patient’s inquiry, collected by pre-designed forms.
(2) The satisfaction of patients and family members will be evaluated in the pre-designed questionnaire, which consists of 11 domains. These domains are: environment, disease, dietary, daily life and behavior, smoking situation and advice of giving up smoking, enhanced recovery after surgery, health examination, taking medicine, safety knowledge, duration of health education, and the kind of health education Every term of the questionnaire is represented by stars from one to five, also one to five scores, where one star represents unsatisfactory, and five stars represent highly satisfactory. The questionnaire is ranged from 11 to 55, 11-21 represents unsatisfactory, 22-32 represents not quite satisfactory, 33-43 represents generally satisfactory and 44-55 represents highly satisfactory.
(3) The satisfaction of doctor and nurse will be accessed by pre-designed questionnaires.,It assesses doctor’s and nurse’s satisfaction after health education on admission under the following domains environment, disease, dietary, daily life and behavior, smoking situation and advise to give up smoking, rapid recovery, health examination, taking medicine, safety knowledge, duration of health education, and the way of health education,service attitude, professional knowledge, patient's condition and professional image. This questionnaire has 15 satisfaction questions, every term of the questionnaire is represented by stars from one to five, and also one to five scores, where one star represents unsatisfactory, and five stars represent highly satisfactory. The scores range from 15 to 75, where a score of 11-29 represents unsatisfactory, a score of 30-44 represents not quite satisfactory, 45-59 represents generally satisfactory and a score of 60-75 represents highly satisfactory.
The secondary outcomes are patients' anxiety level before and after health education, patients’ family members health education content enquire time, and the health education videos watching time.
(1) Patients' anxiety level before and after health education is measured by the Zung Self-Rating Anxiety Scale (SAS) [16], which is designed by William WK Zung to quantify the level of anxiety for patients experiencing anxiety related symptoms. The SAS consists of twenty questions which are scored as 1-4 points individually (1, rarely; 2, some of the time; 3, very often/often; 4, almost/always) and have fifteen questions about increasing anxiety levels and five questions about decreasing anxiety levels, resulting in 20-80 raw score. The total raw score consequently has to be converted to an “Anxiety Index”. The clinical interpretation of one's level of anxiety is 20-44 represents normal range, 45-59 represents mild to moderate anxiety levels, 60-74 represents marked to severe anxiety levels and 75-80 represents extreme anxiety levels.
(2) The time taken by patients or their family members, in inquiry and watching the health education videos, are recorded by a pre-designed table.
Participant timeline
Please see table 2.
Sample size
Sample size and statistical power has been calculated by health education Group AB of Statistical Analysis Software (SPSS), based on the previous studies [17] assessing the satisfaction of health education. A power calculation was based on the primary outcome of satisfaction score on the health education of patients. Previous studies [18,19] have demonstrated that a difference in the satisfaction score on the health education of patients between two groups constitutes a clinically meaningful change in satisfaction. Based on the computational formulae to compare the two means and other earlier findings regarding effects of satisfaction of health education, we estimated that a sample size of N=184 (i.e. n=92 participants in each group) will reach a ≥ 80% power to detect a similar clinically relevant difference in the primary outcome measure between the treatment groups at an alpha level of 5% (two-sided test).
Statistical analysis
After the data are entered into Excel, the statistician will check the input data in detail to ensure the rationality and integrity of the data. After the inspection, data will be imported into SPSS 22.0 software for the statistical analysis. All statistical tests will be performed using a two-sided test and p-value less than 0.05 (two tailed) will be considered statistically significant. Quantitative data will be summarized using mean and standard deviation (M±SD), qualitative data will be expressed as frequency distribution, and Kolmogorov-Smirnov test will be used to assess whether normal distribution is satisfied. Chi-square test will be used to analyze the relationship between independent qualitative data, t-test will be used to compare the mean values between the two groups for quantitative data satisfying normal distribution, and rank sum test will be used to compare the average values of the two groups for quantitative data not satisfying normal distribution. Analysis of variance will be implemented to compare the continuous variables between the groups.
Recruitment
The recruitment would last 12 months and began in August 2019. This duration was estimated based on the number of patients admitted to the Special Surgery Department of the first hospital of Lanzhou University, in the past 2 years. To obtain the adequate participant enrollment, relevant work on the study would be performed around the clock, including the nights and weekends.
Data management and monitoring
Specially trained study staff will collect the data required for the trial. The research staff will interview each participant at baseline to collect the data on patient characteristics and conduct the assessments for those questionnaire-based outcomes. During the interview, participant will receive paper-based assessment forms (questionnaires), and will be given adequate time for the completion of these. The completeness of each questionnaire will be checked at the end of the interview by the research staff for the quality purposes. To reduce study staff bias, study staff will be retained and supervised weekly to ensure the optimum degree of comparability. The source of information will be the patients and their family members. Data will be recorded on a case table at the time of assessment and data collection will be held at the hospital. All data are controlled by two people and entered into the computer. This allows for plausibility checks at the time of input and will avoid the errors that would otherwise result from transferring the data from written notes to a computer. Written informed consent forms will be kept in a locked filing cabinet, while a password-protected list that matches participant ID numbers with personal information will be stored separately from pseudo-anonymized data. List matching participants’ personal information with their ID number will be deleted and consent forms maculated 5 years after study completion. At this point, all data will be completely anonymous. All trial authors will have access to the ultimate trial dataset.
Harm, and auditing
Serious and nonserious adverse events, considered related to the trial, will be rigorously and carefully recorded. A auditing committee consisting of a surgeon and a nurse will supervise the trial at least once every month. They remain independent audit the frequency, procedures, blind and safety of the trial.
Quality assurance and safety
Research and Design Phase
(1) At the stage of research and design, communicate with qualified teachers, discuss the feasibility of research methods and ensure the correct implementation of each link. (2) Before the start of the study, all researchers should be able to understand and master the purpose, content, steps and precautions of the study, and should be tested. After the start of the study, follow-up guidance should be provided to the researchers to ensure the quality of the study.
Data collection stage
(1) Formulate the strict inclusion and exclusion criteria, and to select research objects strictly according to the inclusion criteria. (2) During the course of the study, the researchers give accurate records of the health education and the patient’s condition every day. (3) All the members of this research group are nurses that have worked in the department of general surgery for more than five years and have received special health education training. The members of the research group include instructors, researchers, data collectors and statisticians. They have a clear division of the labor and all work together. (4) Subject group members regularly give feedback on the research, discuss the existing problems and make plans for the next month.
Data entry and analysis stage
(1) On the data input stage, all data will be checked by two people and entered, and statistical analysis will be carried out on the premise of ensuring the correctness of data.
(2) In the process of data analysis, all are instructed to listen to the advice of the professional statistical instructor.
Ethical considerations
This is a clinical experimental study and will not cause substantial moral hazard. In the process of research, the following principles would be strictly observed: (1) the principle of informed consent would be followed. Only those subjects will be included who understand the nature and purpose of the study and voluntarily agree to participate and sign a written informed consent. (2) Patients would have the right to refuse participation and withdrawal at any time. (3) This research would be beneficial for the patients’ disease recovery and physical and mental development. (4) The researchers would keep the personal information obtained in this research confidential. When research results are published publicly, no matter whether the patients agree or not, are all aliases, and the real name will not appear.
Protocol amendments
Any changes to the inclusion criteria, outcomes, and analyses would require approval from the ethics committee and the clinical trial.
Confidentiality
Data would be treated in a confidential manner. During the whole experiment, the patient's name, hospitalization number, and other sensitive information would not be exposed through coding.
Access to data
All investigators will have access to the final trial data set after the end of the study.
Dissemination
Results will be presented at academic conferences and published in peer-reviewed journals. We will inform the participants of the results via E-mail.