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  • Status : Approved
    • First Submitted Date : 2018/12/10
    • Registered Date : 2019/02/12
    • Last Updated Date : 2019/01/21
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1. Background

Background Information
CRIS
Registration Number
KCT0003491 
Unique Protocol ID EMC 2018-05-012-002 
Public/Brief Title Effects of aromatherapy foot bath and aroma spray on nurse’s lower extremity edema, pain, fatigue, stress 
Scientific Title Effects of aromatherapy foot bath and aroma spray on nurse’s lower extremity edema, pain, fatigue, stress  
Acronym  
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 EMC 2018-05-012-002 
Approval Date 2018-08-15 
Institutional Review Board  
Name Eulji University Hospital clinical examination committee 
Address Eulji University Hospital 1306, Dungsan 2-dong, Seo-gu, Daejeon 302-799 
Telephone 042-611-3199 
Data Monitoring Committee    

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Han A Ri 
Title Graduate student 
Telephone +82-42-611-3627 
Affiliation Eulji University Hospital 
Address Daejeon Metropolitan City, Seong-gu, Dunsan-gu, Korea 95, Eulji University Hospital 
Contact Person for Public Queries
Name Han A Ri 
Title Graduate student 
Telephone +82-42-611-3627 
Affiliation Eulji University Hospital 
Address Daejeon Metropolitan City, Seong-gu, Dunsan-gu, Korea 95, Eulji University Hospital 
Contact Person for Updating Information
Name Han A Ri 
Title Graduate student 
Telephone +82-42-611-3627 
Affiliation Eulji University Hospital 
Address Daejeon Metropolitan City, Seong-gu, Dunsan-gu, Korea 95, Eulji University Hospital 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Active, not recruiting  
Date of First Enrollment 2018-08-15 , Actual
Target Number of Participant 78
Primary Completion Date 2018-10-11 , Actual
Study Completion Date 2019-01-31 , Anticipated
Recruitment Status by Participating Study Site 1
Name of Study Site Eulji University Hospital 
Recruitment Status Active, not recruiting  
Date of First Enrollment 2018-08-15 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Eulji University Hospital 
Organization Type Medical Institute  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Eulji University Hospital 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary The purpose of this study was to investigate the effects of aroma foot bath or aroma spray on nurses' lower extremities edema, lower extremities pain, fatigue and stress.
Because nurses are more likely to stand and work than to sit and work, the ower extremities edema and lower extremities pain are reported to be common job related health problems.
In addition, due to the increasing demand of various nursing care of medical consumers, stressful job and fatigue are frequent in shift work.
Aroma foot bath and aroma spray are applied to promote the physical and mental health of nurses.
The hypothesis of this study is as follows.
First hypothesis: There will be differences in the effect of lower extremities edema in experimental group 1, experimental group 2 and control group after experimental treatment.
1-1) Part 1: The calf circumference of experimental group 1, experimental group 2 and control group will be different after experimental treatment.
1-2) Part 2: There will be differences in the ankle circumference of experimental group 1, experimental group 2 and control group after experimental treatment.
Second hypothesis: There will be differences in lower extremity pain in experimental group 1, experimental group 2 and control group after experimental treatment.
Third hypothesis: There will be a difference in fatigue between experimental group 1, experimental group 2 and control group after experimental treatment.
3-1) Part 1: Subjective fatigue of experimental group 1, experimental group 2 and control group after experimental treatment will be different.
3-2) Part 2: Fatigue index of experimental group 1, experimental group 2 and control group after experimental treatment will be different.
Fourth Hypothesis: There will be a difference in the stress between the experimental group 1 and the experimental group 2 and the control group after the experimental treatment.
4-1) Part 1: The perceived stress of experimental group 1, experimental group 2 and control group will be different after experimental treatment.
4-2) Part 2: Stress index of experimental group 1, experimental group 2 and control group after experimental treatment will be different.
This study is a randomized, comparative control study to compare the effects of aromatherapy foot bath and aroma spray on lower extremities edema, lower extremities pain, fatigue and stress.
In this study, aroma foot bath was applied to experimental group 1, aroma spray was applied to experimental group 2, and no treatment was applied to the control group.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Basic Science    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Behavioral  
Intervention Description Experimental group 1 (Aroma foot bath): Grapefruit and peppermint were selected and blended with oil. Then, foot was dropped by 0.5 cc into 9 L of water and the foot was held at a depth of 20 cm from the ankle using a foot bath (SHF-M850, Kores) And immersed at 40 ℃ for 30 minutes.
Experiment 2 (Aromatherapy Spray): Grapefruit and peppermint are selected and blended. The blended oil is dissolved in a solubilizer and diluted in distilled water. The spray is sprayed three times in 10 minute intervals on both sides in a way that it is applied to the skin with small droplets by putting it in a container capable of spraying the aqueous solution.  
Number of Arms
Arm 1 Arm Label aroma foot bath group 
Target Number of Participant 26 
Arm Type Experimental 
Arm Description Experimental group 1 (Aroma foot bath): Grapefruit and peppermint were selected and blended with oil. Then, foot was dropped by 0.5 cc into 9 L of water and the foot was held at a depth of 20 cm from the ankle using a foot bath (SHF-M850, Kores) And immersed at 40 ℃ for 30 minutes. 
Arm 2 Arm Label aroma spray group 
Target Number of Participant 26 
Arm Type Experimental 
Arm Description Experimental group 2 (aroma spray group) : Grapefruit and peppermint were blended at a ratio of 1: 1, and distilled water was used as a solvent. It was placed on a chair with a backrest and sprayed on both legs by a spraying method, and each of them was rested for 30 minutes during a total of 3 injections every 10 minutes. It was used by shaking with each use. The injection amount was 4cc per one injection, and the total injection amount was 12cc per 3 times. 
Arm 3 Arm Label Untreated group 
Target Number of Participant 26 
Arm Type No intervention 
Arm Description Control group: sat on a chair with a backrest and took a rest for 30 minutes without any intervention. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the circulatory system
lower extremities edema  
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 20 Year ~ 40 Year
Description 1. Those who understand the research purpose and voluntarily agree to participate in the research
2. Among nurses who are 20 years of age or older and under 40 years of age,  
Exclusion Criteria ① Those who have open wounds on their feet or legs.
② Those who have skin diseases
③ Those with contraindications to aromatic essential oils
④ a pregnant person
⑤ a person with high blood pressure  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Safety 
Primary Outcome(s) 1 
Outcome lower extremities edema 
Timepoint Before work, before experiment, after 30 minutes of experiment 
Primary Outcome(s) 2 
Outcome lower extremities pain 
Timepoint Before working, before experiment, after 10 minutes, after 20 minutes, after 30 minutes 
Primary Outcome(s) 3 
Outcome fatigue 
Timepoint Before working, before experiment, after 10 minutes, after 20 minutes, after 30 minutes 
Primary Outcome(s) 4 
Outcome stress 
Timepoint Before working, before experiment, after 10 minutes, after 20 minutes, after 30 minutes 
Secondary Outcome(s) 1 
Outcome stress index 
Timepoint Before the experiment, 30 minutes after the experiment 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

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

Sharing of Study Data Information
Sharing Statement No 
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