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  • Status : Approved
    • First Submitted Date : 2017/04/20
    • Registered Date : 2017/06/01
    • Last Updated Date : 2017/05/18
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1. Background

Background Information
CRIS
Registration Number
KCT0002344 
Unique Protocol ID EMC 2016-01-003-004 
Public/Brief Title The Effects of Aromatherapy on Stress and Sleep Quality in ICU patients 
Scientific Title Effects on the stress and the quality of sleep applying aromatherapy admitted to ICU patients  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
 

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number EMC 2016-01-003-004 
Approval Date 2016-05-12 
Institutional Review Board  
Name Eulji University Hospital Institutional Review Board 
Address  
Telephone  
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Myung Haeng Hur 
Title Professor 
Telephone +82-42-259-1714 
Affiliation Eulji University 
Address B-617, College of Nursing, Eulji University, 77 Gyeryong-ro 771 beon-gil, Jung-gu, Daejeon, 34824, Korea  
Contact Person for Public Queries
Name Eun Hee Cho 
Title Miss 
Telephone +82-42-259-1714 
Affiliation Eulji University 
Address B-617, College of Nursing, Eulji University, 77 Gyeryong-ro 771 beon-gil, Jung-gu, Daejeon, 34824, Korea  
Contact Person for Updating Information
Name Myung Haeng Hur 
Title Professor 
Telephone +82-42-259-1714 
Affiliation Eulji University 
Address B-617, College of Nursing, Eulji University, 77 Gyeryong-ro 771 beon-gil, Jung-gu, Daejeon, 34824, Korea  

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2016-07-01 , Actual
Target Number of Participant 64
Primary Completion Date 2016-10-15 , Actual
Study Completion Date 2016-10-15 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Eulji University Hospital 
Recruitment Status Completed  
Date of First Enrollment 2016-07-01 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name National Research Foundation 
Organization Type Government  
Project ID NRF-2015R1A1A3A04001 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Eulji University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary <Purpose and background>
Admission to a hospital is a kind of life event that causes changes in daily life and activities as well as physical stress caused by illness, so that the patient experiences mental and social stress. In particular, most patients entering the intensive care unit (ICU) have a high degree of symptoms, a high probability of death, and a high need for nursing care. The intensive care unit is surrounded by many medical staff and various mechanical devices. Therefore, the ICU patients experience serious emotional disparities caused by fear of being an ICU, uncertainty about prognosis, isolation from family, financial burden, and exposure to unfamiliar environment. Aromatherapy, which has recently emerged as an alternative therapy, has been recognized as a part of nature, focusing on balance and harmony, and using therapeutic ingredients of essential oils in flowers, leaves, stems and roots of various natural plants. It is a kind of complementary therapy that promotes the physical, mental and psychological health of the subject. This study, after applying aromatherapy as a nursing intervention to improve the quality of sleep and to reduce the stress in the ICU patients, was tried to evaluate the effects of stress and sleep quality on ICU patients .

<Research hypothesis>
1) 1st hypothesis: There will be a difference in stress between the experimental group applying aromatherapyand the control group.
• Perceived stress of experimental group and control group will be different.
• The stress index of the experimental group and the control group will be different.
• Systolic blood pressure of the experimental group and the control group will be different.
• Diastolic blood pressure of the experimental group and the control group will be different.
• Heart rate between experimental group and control group will be different.

2) 2nd hypothesis: There will be a difference in the quality of sleep (VHS) between the experimental group and the control group.

<Research Method>
Subjects were adult patients with clear consciousness who entered the intensive care unit and slept for 2 days or more. The final study subjects were 30 patients in the experimental group and 30 patients in the control group who satisfied the selection criteria and exclusion criteria. The study was reviewed before the data were collected and received approval from the clinical trial committee of E University Hospital.
The experimental procedure was to inhale essential oils with aromatherapy. To confirm the effectiveness of the aromatherapy, three drops of lavender aroma essential oil were applied to the Aroma stone before the sleep, and deep breathing was performed 10 times. After the incense was taken, the aroma stone was hanged on the bedside railing, The control group was given sleep without providing lavender aroma oil.
Measurements were made within 1 hour of entering the intensive care unit (ICU), 2 days before and after taking the sleep, and stress and sleep quality were measured.
Perceived stress, stress index, systolic and diastolic blood pressures and heart rate were measured and the quality of sleep was assessed using the VSH (Verran & Snyder-Halpern) tool.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Treatment    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation Non-RCT 
Intervention Type Others (Inhalation of Aromatherapy Essential oils)
Intervention Description The subjects of this study were randomly assigned to the experimental group and the control group, the experimental group was the aromatherapy group, and the control group was the no treatment group and did not provide aromatherapy intervention. The experimental treatment was to apply aromatherapy. The experimental procedure was started at 9:00 pm and 3 drops of lavender essential oil were applied to Aroma Stone to perform deep breathing 10 times. After taking the essential oil by deep breathing, aroma stone was placed in the center of the bedside bed so that it was placed within 10cm and sleep was taken (Aromatherapy 1). On the second day of hospitalization, 3 drops of lavender essential oil were applied to Aroma Stone and deep breathing was performed 10 times. Aromatherapy was applied to the center of the bedside bed with a breathing aroma essential oil (Aromatherapy 2). The control group did not provide any experimental treatment.  
Number of Arms
Arm 1 Arm Label Aromatherapy group 
Target Number of Participant 32 
Arm Type Experimental 
Arm Description The application of aromatherapy in this study is as follows. ① Experimental treatment was to apply aromatherapy. The experimental procedure was started at 9:00 pm and 3 drops of lavender essential oil were applied to Aroma Stone to perform deep breathing 10 times. After taking the essential oil by deep breathing, Aroma stone was placed in the center of the bedside bed and hanged so that it could be placed within 10cm (Aromatherapy 1). Aroma stone was removed at 8:00 am when the essential oil was inhaled and the sleep was over. ② On the second day of hospitalization, 3 drops of lavender essential oil were applied to Aroma stone and deep breathing was performed 10 times. After deep breathing, the aroma stone was placed in the middle of the bedside bed, and placed to be placed within 10cm to take sleep (Aromatherapy 2). Aroma stone was removed at 8:00 am when the essential oil was inhaled and the sleep was over. 
Arm 2 Arm Label Control group 
Target Number of Participant 32 
Arm Type No intervention 
Arm Description The procedure for the control group of this study is as follows. ① The control group did not provide experimental treatment, the control group did a pre-pretest, and after that, they did not provide any treatment and took sleep. We conducted the first post-test at 8 am, the end of the next day's sleep. ② On the second day of admission, the control group did not provide any experimental treatment, and the second post-test was performed at 8:00 am the next day after the end of sleep 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of the circulatory system
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 70 Year
Description &lt;Selection Criteria&gt; <br />① Patients between the ages of 18 and 70 <br />② Those who are conscious and have enough communication <br />③ Those who enter the intensive care unit and sleep for 2 days or more <br />④ Understand the purpose of this study and allow the participant to participate in this study  
Exclusion Criteria &lt;Exclusion criteria&gt; <br />① Those with mental illness <br />② Those taking an antianxiety drugs and sleeping pills <br />③ Those who have side effects and allergies to aromatic essential oils <br />④ Those who enter the intensive care unit between 7 pm and 5 am <br />⑤ Those whose systolic blood pressure is less than 100 mmHg (except for blood pressure may be lowered due to the nature of lavender essential oil) <br />⑥ Those with arrhythmia <br />  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Not applicable 
Primary Outcome(s) 1 
Outcome Perceived Stress 
Timepoint 1 hour after admission on the first day, 8:00 pm on the first day, 8:00 am and 8pm on the second day, 8:00 am on the third day 
Primary Outcome(s) 2 
Outcome Sleep Quality 
Timepoint 1 hour after admission on the first day, 8:00 am on the second day, 8:00 am on the third day 
Primary Outcome(s) 3 
Outcome Stress index 
Timepoint 1 hour after admission on the first day, 8:00 pm on the first day, 8:00 am and 8pm on the second day, 8:00 am on the third day 
Secondary Outcome(s) 1 
Outcome Blood Pressure 
Timepoint 1 hour after admission on the first day, 8:00 pm on the first day, 8:00 am and 8pm on the second day, 8:00 am on the third day 
Secondary Outcome(s) 2 
Outcome Heart Rate 
Timepoint 1 hour after admission on the first day, 8:00 pm on the first day, 8:00 am and 8pm on the second day, 8:00 am on the third day 

11. Study Results and Publication

Study Results and Publication Information
Result Registered

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

Sharing of Study Data Information
Sharing Statement No 
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