An Online 5-week Professional Identity Group Psychotherapy for Nursing Student During Clinical Rotation Practice
Phase: NA
Conditions: Identification (Psychology)
Sponsor: Central South University

Full study protocol and statistical analysis plan 
 
Official Title of the study: 
An online 5-week professional identity group psychotherapy for nursing 
student during clinical rotation practice 
 
Date of the document: 
3rd June 2020 
 
Contents: 
1. Participant Flow 
2. Baseline Characteristics 
3. Outcome Measures 
4. Adverse Event Information 
5. Limitations and Caveats 
6. Certain Agreements 
7. Results Point of Contact 
 
 
 

1. Participant Flow 
Recruitment Details  
We will choose School of Nursing, FudanUniversity to recruit the participants. The recruitment 
will start at May 1st 2020. The recruitment announcement will be distributed to the participants 
via online notice transmission software used by the school. 
Pre-assignment Details [*]  
We firstly will assess the recruited people to ensure meeting the inclusion and exclusion criteria.  
Than the final enrolled participants can be sure and randomized assignment will be conducted. 
Enrollment (total, anticipatory) 
110 
Record the number of the eligible 
and the excluded 
Allocation (randomized)  
Group A 
Group B 
Record the number of the received 
and the unreceived 
 
55 
55 
Follow-up  
(immediately after intervention)  
 
 
Record the number of the received 
and the unreceived 
 
Arm/Group Information *  
There are two groups in the study.  
Arm/Group Title *  
Intervention group= Group A 
Controlled group= Group B 
Arm/Group Description *§  
Intervention group: Students will be intervened by an online 5-week professional identity group 
psychotherapy. 
Controlled group will receive online messages of self-care knowledge forward by researchers. 
 
Period(s) *  
There is only one stage in the study.  
Period Title *  
Overall Study.  
Started *  
There will be 110 participants initiating the intervention.  
Those 110 participants come from two classes in the same grade. One will be randomly allocated 
as the intervention group, the other will be control group.  
Completed *  
We will do follow-up post intervention, and the number in the follow-up will be recorded. 
Milestone Title [*]  
Before the intervention, we will measure the participants, and the stage is defined as T0. 
We will do follow-up immediately after intervention, defined as T1.  
Reason Not Completed Type [*]  
We will record the exact reason (Adverse Event) why participants do not complete the study. The 
reason may be not interested, lack of efficacy, lost to follow-up, withdrawal by subject or others. 
 
2. Baseline Characteristics 
Arm/Group Information *  
Chi-square test will be applied to figure out the difference of enumeration data between two 
groups. ANOVA will be applied to test the difference of measurement data between two groups. 
F values and χ2 values will be displayed to show the baseline data are no different in two groups.  
Arm/Group Title *  
Intervention group= Group A 
Controlled group= Group B 
Arm/Group Description *§  
Those 110 participants come from two classes in the same grade. One will be randomly allocated 
as the intervention group, the other will be control group.  
 

Overall Number of Baseline Participants *  
There will be 110 participants initiating the intervention.  
Baseline Measure Information *  
A group of demographic characteristics will be measured in the study, including gender, age, 
income per month of the family, etc. 
Baseline Measure Title *  
• 
Age * : Continuous(years) 
• 
Gender * : Female, Male  
• 
Income per month: Categorical: 
• 
<=1000 RMB 
• 
>1000 and <2000 RMB 
• 
>=2000 RMB 
• 
The reason of being a nurse: nominal: 
• 
Out of interest 
• 
Advice from parents 
• 
Others 
Measure Type *  
• 
Count of Participants: Gender 
• 
Mean: Age 
• 
Number: Income per month, The reason of being a nurse 
Measure of Dispersion *  
• 
Standard Deviation 
• 
Inter-Quartile Range 
• 
Full Range 
Baseline Measure Data *  
The value(s) for each baseline measure, for each group and overall cannot obtain right now since 
the study has not been started.  
 
 
 3. Outcome Measures 
Outcome Measure Information *  
A questionnaire will be used during each measurement, including several scales in it. 
Outcome Measure Type *  
• 
Primary and secondary 
Outcome Measure Title *  
• 
Professional identity: professional identity in recent one week measured by Chinese 
Profession identity scale for nursing student. It is a self-reported scale by adding up 17 
items and the total score ranges from 17-85, with higher score reflects higher 
professional identity.  
• 
Career self-efficacy: career self-efficacy in recent one week measured by Chinese career 
self-efficacy scale for nursing student. It is a self-reported scale by adding up 27 items 
and the total score ranges from 27-135, with higher score reflects higher career 
self-efficacy.  
• 
Stress: a reflection of one's perceived stress in recent month measured by the subscale 
from the Depression, Anxiety, and Stress Scale (DASS-21). It is a self-reported scale, with 
7 items in the stress subscale scoring from 0-21. The higher score, the higher stress.  
• 
Resilience: resilience in recent one week measured by Chinese version of 
Connor-Davidson Resilience Scale-10. It is a self-reported scale by adding up 10 items 
and the total score ranges from 0-40, with higher score reflects higher resilience.  
• 
General rating: several descriptive question to gather the feedback of the intervention. 
Outcome Measure unit * 
The professional identity, career self-efficacy, stress, and resilience are measured by scales with 
no unit. 
 

Outcome Measure Time Frame *  
There will be two measurements, before the intervention and immediately after intervention. 
They are defined as T0, T1. 
Analysis Population Information  
Overall Number of Participants Analyzed *  
There will be 110 participants totally enrolled in the study.  
Outcome Measure Data Table  
Measure Type *  
• 
Mean 
Measure of Dispersion/Precision *  
• 
Standard Deviation 
Outcome Data *  
The measurement value(s) for each outcome measure cannot obtain right now since the study 
has not been started. 
 
Statistical Analysis Overview  
Comparison Group Selection [*]  
We will compare two groups’ data.  
Type of Statistical Test [*]  
• 
Superiority 
• 
Other (descriptive analysis) 
P-Value [*]  
P-Value will be set at 0.05. 
Method [*]  
• 
ANOVA 
• 
Chi-Squared 
• 
t-Test, 2-Sided 
• 
Other: repeated measurement of variance analysis within different measurements 
among different groups  
Estimation Parameter [*]  
• 
Mean Difference (Final Values) 
 
 
 4. Adverse Event Information 
Time Frame *§  
The intervention lasts around 35 days, with 5 times, and we will record the adverse event at each 
time.  
Adverse Event Reporting Description [*]  
We will add relevant information about adverse event after finishing the study.   
Collection Approach for Table Default *§ 
• 
Systematic Assessment: The psychotherapist will routinely determine whether or not 
certain adverse events have occurred through regular investigator assessment during 
intervention and in each follow-up. 
• 
Non-Systematic Assessment: Self-reporting by participants or occasional assessment by 
the psychotherapist. 
Adverse Event Term *  
The most possible adverse event may be the psychological discomfort because the participants.  
We will provide information for in two tables summarizing adverse events in each group, 
including serious adverse events, and other (not including serious) adverse events.  
Organ System *  
• 
Psychiatric Disorders 
 
 
 

5. Limitations and Caveats 
The measurements are mostly based on self-reported scales and may lead to unreliable data. We 
will give instruction before fulfilling the questionnaire to ensure the participants understood. 
 
 
6. Certain Agreements 
Are all PIs Employees of Sponsor? *  
• 
No: The principal investigator is not an employee of the sponsor 
There is no agreement between the agent (university) and the principal investigators. The 
principal investigators are graduate students in the university. The principal investigators (PIs) can 
discuss the results of the study at a scientific meeting or any other public or private forum, or to 
publish in a scientific or academic journal information concerning the results of the study. 
 
 
7. Results Point of Contact 
Name or Official Title *  
Lecturer: Anni Wang 
Organization Name *  
School of Nursing, Fudan University 
Phone: *§  
+86-13467620600 
Email: *§  wanganni1990@163.com