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- Status : Approved
- First Submitted Date : 2020/04/20
- Registered Date : 2020/04/21
- Last Updated Date : 2020/04/21
| 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 |
| 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 |
| 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 | |
| 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 |
| Source of Monetary/Material Support 1 | ||
|---|---|---|
| Organization Name | Pusan National University | |
| Organization Type | University | |
| Project ID | ||
| Sponsor Organization 1 | ||
|---|---|---|
| Organization Name | Pusan National University | |
| Organization Type | University | |
| 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. |
|---|
| 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 | 1 | |
| 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. | |
| 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 | |
| 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) |
| Result Registered | No |
|---|
| Sharing Statement | No |
|---|
