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Effects of Aromatherapy Combined with Music Therapy on Test Anxiety, State Anxiety, Stress, and Fundamental Nursing Skills Performance in Nursing Students

Status Approved

First Submitted Date

2019/09/06
Registered Date

2019/09/10
Last Updated Date

2019/09/10

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004293
Unique Protocol ID	SSWUIRB 2017-055
Public/Brief Title	Effects of Aromatherapy Combined with Music Therapy on Test Anxiety, State Anxiety, Stress, and Fundamental Nursing Skills Performance in Nursing Students
Scientific Title	Effects of Aromatherapy Combined with Music Therapy on Test Anxiety, State Anxiety, Stress, and Fundamental Nursing Skills Performance in Nursing Students
Acronym	ACMT
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	SSWUIRB 2017-055
Approval Date	2017-09-13
Institutional Review Board Name	Sungshin Women's University Institutional Review Board
Institutional Review Board Address	2, Bomun-ro 34da-gil, Seongbuk-gu, Seoul
Institutional Review Board Telephone	02-920-7739
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Myoungsuk Kim
Title	Assistant Professor
Telephone	+82-33-250-8877
Affiliation	Kangwon National University
Address	Kangwon National University, Chuncheon campus, 55 1 Gangwondaehakgil, Chuncheon-Si, Gangwon-Do
Contact Person for Public Queries
Name	Myoungsuk Kim
Title	Assistant Professor
Telephone	+82-33-250-8877
Affiliation	Kangwon National University
Address	Kangwon National University, Chuncheon campus, 55 1 Gangwondaehakgil, Chuncheon-Si, Gangwon-Do
Contact Person for Updating Information
Name	Myoungsuk Kim
Title	Assistant Professor
Telephone	+82-33-250-8877
Affiliation	Kangwon National University
Address	Kangwon National University, Chuncheon campus, 55 1 Gangwondaehakgil, Chuncheon-Si, Gangwon-Do

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2017-10-01 Actual
Target Number of Participant	107
Primary Completion Date	2017-11-30 , Actual
Study Completion Date	2017-11-30 , Actual
Name of Study	Sungshin Women's University
Recruitment Status	Completed
Date of First Enrollment	2017-10-01 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Kangwon National University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kangwon National University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	-Purpose & Background: Background: Nursing students often experience anxiety and stress over taking fundamental nursing skills performance tests. Complementary alternative methods such as aromatherapy and music therapy have been effective strategies to alleviate negative emotions among nursing students. However, there have been few studies on interventions with combined therapies or on the comparison of effects between interventions. This study aimed to identify the effects of aromatherapy combined with music therapy as well as different interventions on test anxiety, state anxiety, stress, and fundamental nursing skills performance among nursing students in Korea. --Hypothesis 1. The experimental group using aromatherapy combined with music therapy will have lower test anxiety than a single intervention group receiving aromatherapy or music therapy. Hypothesis 2. The experimental group using aromatherapy combined with music therapy will have lower state anxiety than a single intervention group receiving aromatherapy or music therapy. Hypothesis 3. The experimental group using aromatherapy combined with music therapy will have lower stress than a single intervention group receiving aromatherapy or music therapy. Hypothesis 4. Experimental group using aromatherapy combined with music therapy will perform better fundamental nursing skills performance than a single intervention group receiving aromatherapy or music therapy -Methods: A double-blinded randomized controlled trial design was used. The study was conducted at a college of nursing in a university, Seoul, South Korea. Of the 107 eligible participants from college of nursing, 107 participants were enrolled. the participants were randomly assigned to the aromatherapy group(n=36), music therapy group(n=35), and aromatherapy combined with music therapy group(n=36). A total of 98 sophomore nursing students excluding those 9 subjects were analyzed. Aromatherapy was carried out through the inhalation method using an aroma lamp and three drops of Origanum majorana and Citrus sinensis. Music therapy was carried out using Beethoven’s “Moonlight” Sonata and acoustics. Interventions were performed in separate rooms and lasted 20 minutes each before the fundamental nursing skills exam was administered. Data were collected through self-reported questionnaires regarding demographics, test anxiety, state anxiety, and stress, and evaluation of skill performance with regard to Foley catheterization. - Results: Aromatherapy combined with music therapy had a significant effect on test anxiety(F=4.29, p=.016), state anxiety(F=4.77, p=.011), stress(F=4.62, p=.012), and fundamental nursing skills performance(F=8.04, p=.001), compared with aromatherapy and music therapy as a separate intervention.

Study Summary Information

Lay Summary

-Purpose & Background: Background: Nursing students often experience anxiety and stress over taking fundamental nursing skills performance tests. Complementary alternative methods such as aromatherapy and music therapy have been effective strategies to alleviate negative emotions among nursing students. However, there have been few studies on interventions with combined therapies or on the comparison of effects between interventions. This study aimed to identify the effects of aromatherapy combined with music therapy as well as different interventions on test anxiety, state anxiety, stress, and fundamental nursing skills performance among nursing students in Korea.
--Hypothesis 1. The experimental group using aromatherapy combined with music therapy will have lower test anxiety than a single intervention group receiving aromatherapy or music therapy.
Hypothesis 2. The experimental group using aromatherapy combined with music therapy will have lower state anxiety than a single intervention group receiving aromatherapy or music therapy.
Hypothesis 3. The experimental group using aromatherapy combined with music therapy will have lower stress than a single intervention group receiving aromatherapy or music therapy.
Hypothesis 4. Experimental group using aromatherapy combined with music therapy will perform better fundamental nursing skills performance than a single intervention group receiving aromatherapy or music therapy
-Methods: A double-blinded randomized controlled trial design was used. The study was conducted at a college of nursing in a university, Seoul, South Korea. Of the 107 eligible participants from college of nursing, 107 participants were enrolled. the participants were randomly assigned to the aromatherapy group(n=36), music therapy group(n=35), and aromatherapy combined with music therapy group(n=36). A total of 98 sophomore nursing students excluding those 9 subjects were analyzed. Aromatherapy was carried out through the inhalation method using an aroma lamp and three drops of Origanum majorana and Citrus sinensis. Music therapy was carried out using Beethoven’s “Moonlight” Sonata and acoustics. Interventions were performed in separate rooms and lasted 20 minutes each before the fundamental nursing skills exam was administered. Data were collected through self-reported questionnaires regarding demographics, test anxiety, state anxiety, and stress, and evaluation of skill performance with regard to Foley catheterization.
- Results: Aromatherapy combined with music therapy had a significant effect on test anxiety(F=4.29, p=.016), state anxiety(F=4.77, p=.011), stress(F=4.62, p=.012), and fundamental nursing skills performance(F=8.04, p=.001), compared with aromatherapy and music therapy as a separate intervention.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Others (Randomized Controled Trial)
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Others (Relaxation therapy)
Intervention Description	-Aromatherapy Combined with Music Therapy group : Aromatherapy and music therapy were applied for 20 minutes as follows. -Aromatherapy group : Aromatherapy was carried out through the inhalation method using an aroma lamp and three drops of Origanum majorana and Citrus sinensis for 20 minutes. -Music therapy group : Music therapy was carried out using Beethoven’s “Moonlight” Sonata and acoustics. Interventions were performed in separate rooms and lasted 20 minutes each before the fundamental nursing skills exam was administered.
Number of Arms	3
Arm 1	Arm Label Aromatherapy combined with music therapy group
	Target Number of Participant 36
	Arm Type Experimental
	Arm Description -Aromatherapy Combined with Music Therapy group : Aromatherapy and music therapy were applied for 20 minutes as follows. Aromatherapy was carried out through the inhalation method using an aroma lamp and three drops of Origanum majorana and Citrus sinensis for 20 minutes. Music therapy was carried out using Beethoven’s “Moonlight” Sonata and acoustics. Interventions were performed in separate rooms and lasted 20 minutes each before the fundamental nursing skills exam was administered.
Arm 2	Arm Label Aromatherapy group
	Target Number of Participant 36
	Arm Type Active comparator
	Arm Description Aromatherapy was carried out through the inhalation method using an aroma lamp and three drops of Origanum majorana and Citrus sinensis for 20 minutes.
Arm 3	Arm Label Music therapy group
	Target Number of Participant 35
	Arm Type Active comparator
	Arm Description Music therapy was carried out using Beethoven’s “Moonlight” Sonata and acoustics. Interventions were performed in separate rooms and lasted 20 minutes each before the fundamental nursing skills exam was administered.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Quality of life Students, Nursing
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~No Limit
	Description -Sophomore nursing students -Nursing college students who need to evaluate fundamental nursing skills performance
Exclusion Criteria	-Nursign students who were allergic to the aroma of essential oils -Nursing students who had hearing impairments that prevented them from undergoing music therapy. -Nursing students who participating in relaxation interventions that affected their anxiety and stress -Nursing students who were taking medicine for mental and bodily relaxation
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Test anxiety
Timepoint	Pre and post the fundamental nursing skills performance
Primary Outcome(s) 2
Outcome	Fundamental Nursing Skills Performance
Timepoint	Post the fundamental nursing skills performance
Primary Outcome(s) 3
Outcome	State anxiety
Timepoint	Pre and post the fundamental nursing skills performance
Secondary Outcome(s) 1
Outcome	Stress
Timepoint	Pre and post the fundamental nursing skills performance

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	Yes Results Upload
Final Enrollment Number	98
Number of Publication	0
Results Upload	result.pdf
Date of Posting Results	2019/09/10
Protocol URL or File Upload	protocol.pdf
Brief Summary	Aromatherapy combined with music therapy had a significant effect on test anxiety(F=4.29, p=.016), state anxiety(F=4.77, p=.011), stress(F=4.62, p=.012), and fundamental nursing skills performance(F=8.04, p=.001), compared with aromatherapy and music therapy as a separate intervention.

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

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2019. 9
Way of Sharing	Available on Request (033-250-8877(cellylife@gmail.com))

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