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  • Status : Approved
    • First Submitted Date : 2020/04/20
    • Registered Date : 2020/04/21
    • Last Updated Date : 2020/04/21
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1. Background

Background Information
CRIS
Registration Number
KCT0004948 
Unique Protocol ID PNU IRB/2017_17_HR 
Public/Brief Title Study on the influence of Emotion Freedom Technique on stress and mental health of students enrolled in School of Korean Medical 
Scientific Title Study on the influence of Emotion Freedom Technique on stress and mental health of students enrolled in School of Korean Medical  
Acronym EFTSKMS 
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number PNU IRB/2017_17_HR 
Approval Date 2017-03-27 
Institutional Review Board  
Name Pusan National University Institutional Review Board 
Address 2, Busandaehak-ro 63beon-gil, Geumjeong-gu, Busan 
Telephone 051-510-3677 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Junghwa Lim 
Title associate professor 
Telephone +82-55-360-5979 
Affiliation Pusan National University 
Address 2, Busandaehak-ro 63beon-gil, Geumjeong-gu, Busan, Republic of Korea 
Contact Person for Public Queries
Name Junghwa Lim 
Title associate professor 
Telephone +82-55-360-5979 
Affiliation Pusan National University 
Address 2, Busandaehak-ro 63beon-gil, Geumjeong-gu, Busan, Republic of Korea 
Contact Person for Updating Information
Name Junghwa Lim 
Title associate professor 
Telephone +82-55-360-5979 
Affiliation Pusan National University 
Address 2, Busandaehak-ro 63beon-gil, Geumjeong-gu, Busan, Republic of Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2017-03-31 , Actual
Target Number of Participant 49
Primary Completion Date 2017-05-17 , Actual
Study Completion Date 2017-05-17 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Pusan National University 
Recruitment Status Completed  
Date of First Enrollment 2017-03-31 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Pusan National University 
Organization Type University  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Pusan National University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary The EFT intervention may be beneficial for medical students controlling their stress for the ease of learning and self-practice. However, clinical research using EFT intervention for the reduction of stress and anxiety in medical students were not reported till now, and the influence of EFT intervention on test anxiety, positive affection and negative affection were not studied yet. So there is a need to analyze the usefulness of EFT intervention on stress management and mental health improvement which was shown in previous studies reported in other countries.
Since the qualitative studies on the effect of EFT intervention on stress management were not reported, the qualitative study on the implementation of EFT education based on the meridian theory of Korean medicine which has the quality of psychotherapy might be required.
The current study would peformed the EFT intervention to the enrolled students of School of Korean Medicine, and analyze its effects on stress and mental health management that might provide foundation for establishing stress management program.
The current study would implement the EFT intervention program to the students of School of Korean Medicine, and analyze its effects on stress, test anxiety, state-trait anxiety, positive affection and negative affection.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Supportive Care    
Phase Not applicable 
Intervention Model Single Group  
Blinding/Masking Open 
Allocation Not Applicable 
Intervention Type Behavioral  
Intervention Description The EFT intervention program used for teaching has seven stages based on EFT manual (Craig, 2011) which has six sessions/3 weeks with 15 minutes length. The first, second and third session is for the basic procedure of EFT, and the fourth, fifth and sixth session is for the training of EFT. The EFT group education is for the self-training program for the stress management considering their time and situation. Movie clips would be provided for the easy introduction, As for the psychological discomfort, examples are provided to incorporate their problems into the EFT basic recipe. And, the participants were asked to repeat the EFT program by them self. The worksheet is also provided for the ease of students’ participation, and the instructor encourage them practice the program more than once a day.  
Number of Arms
Arm 1 Arm Label Emotion Freedom Technique group 
Target Number of Participant 49 
Arm Type Experimental 
Arm Description The EFT program used for the education is a seven step program based on EFT manual by Craig (2011). And the lecture on basic procedure is provided at first, second and third meeting, and the practice of EFT basic program is peformed at fourth, fifth session. The EFT group intervention program is for the self-training, and provides movie clip for their learning and practicing. The stress and mental discomfort would be included in the program following the examples provided by the instructor. The EFT basic recipe is made to encourage the self-training of participants, and the instructor encourage them to repeat. The worksheet is provided for the self-excercise of students, and make them practice more than once a day. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Factors influencing health status and contact with health servisces
 Healthy adults older than 20 years
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 65 Year
Description The students of School of Korean Medicine of Pusan National University are eligible for inclusion of current study. All the participants who agreed to the purpose of current study submitted written informed consent with their signature.  
Exclusion Criteria The one who is participating or has participated in other clinical research during the past one month <br />The one who is on leave of absence from school <br />The one who is considered not to be included for clinical research  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Not applicable 
Primary Outcome(s) 1 
Outcome Perceived Stress Scale, PSS 
Timepoint Baseline(1 day before 1st session), End point Evaluation(after 6th session), Follow-Up(after 2weeks from End point Evaluation) 
Secondary Outcome(s) 1 
Outcome State-Trait Anxiety Inventory, STAI 
Timepoint Baseline(1 day before 1st session), End point Evaluation(after 6th session), Follow-Up(after 2weeks from End point Evaluation) 
Secondary Outcome(s) 2 
Outcome Test Anxiety Inventory, TAI 
Timepoint Baseline(1 day before 1st session), End point Evaluation(after 6th session), Follow-Up(after 2weeks from End point Evaluation) 
Secondary Outcome(s) 3 
Outcome Positive Affection Negative Affection schedule, PANAS 
Timepoint Baseline(1 day before 1st session), End point Evaluation(after 6th session), Follow-Up(after 2weeks from End point Evaluation) 
Secondary Outcome(s) 4 
Outcome a written opinion 
Timepoint End point Evaluation(after 6th session) 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
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