Nursing StudentsNCT06381544
The Effect of Aromatherapy Use in Nursing Skills Training
A study testing Aromatherapy application in people with Nursing Students, run by Fenerbahce University at 2 sites in Turkey (Türkiye).
Trial summary
Nursing education is an education in which theory and practice are intertwined and requires the development of both cognitive and motor skills of students. The laboratory environment is a bridge between classroom learning and clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Students
- What is being tested?
- Aromatherapy application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 Feb 2024to 6 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of any respiratory system disease (asthma, COPD, etc.),
- Not having a cardiovascular disease,
- Not being allergic to any odor,
- Lack of pregnancy,
- Not having any obstacle to smell,
- Not using any medication that will affect heart rate and blood pressure,
- It is the absence of a psychiatric disease.
Who cannot join
- Filling out forms incompletely,
- Not agreeing to participate in the study,
- Having previously received skills training for IV catheter application,
- Any side effects occur during application
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Fenerbahce University
Ataşehir, Istanbul, 34758
Fenerbahce University
Istanbul, Atasehir, 34758
About this study
Official title: The Effect of Aromatherapy Use in Nursing Skills Training on Learning and Anxiety Level: Randomized Controlled Study
Nursing education is an education in which theory and practice are intertwined and requires the development of both cognitive and motor skills of students. The laboratory environment is a bridge between classroom learning and clinical practice. In order for students to transform the target behavior into a skill, it takes place in the laboratory on inanimate models under the supervision of the instructor. It has been assumed that there is a strong relationship between learning and anxiety; while a moderate level of anxiety is necessary for learning, a high level of anxiety causes a decrease in learning.
Many studies have reported that students experience anxiety before their first clinical/practice experience. During skills training, it is observed that students are stressed, their hands are shaking, and they do not feel comfortable, especially before practices involving invasive interventions. This is a factor that makes learning skills training difficult. Therefore, it is important for the student to be comfortable, self-confident, and mentally open to learning during skill training. New applications and different techniques for skill training are important in this sense. It is reported that aromatherapy application has positive effects on reducing anxiety and increasing concentration.
Read more
RESEARCH HYPOTHESES:
H0: Aromatherapy has no effect on students' anxiety and learning levels during skill training.
H1: Aromatherapy reduces the anxiety experienced by students during skills training.
H2: Aromatherapy has a positive effect on students' learning nursing skills.
Read the detailed description
The population of the research consists of 81 students enrolled in the first year of nursing. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G*Power 3.1 program. As a similar study in the relevant literature, the effect size regarding stress change was calculated as 0.760. In order to exceed the 95% value in determining the power of the study; At a significance level of 5% and an effect size of 0.760, 42 people, 21 people in the groups, need to be reached (df=20; t=1.725). To avoid bias in the people to be included in the study, they were recruited by randomization according to the order of arrival. The randomization table was created using "https://www.calculatorsoup.com". In the research, it was reached a total of 77 students (experiment=39, control=38).
Introductory Information Form, State-Trait Anxiety Inventory and IV Catheter Application Check List will be used to collect data.
In this study, it is planned to analyze the data in SPSS program. Normality tests, mean, standard deviation, minimum, maximum, number-percentage distributions in data analysis; Independent Groups t-test, Mann Whitney U test, One-Way Analysis of Variance, Kruskal-Wallis test will be used. Differences between groups in terms of categorical variables will be examined with the chi-square test. Pearson correlation analysis will be used to examine the relationships between variables, and Cohen-d effect size will be used to determine the effect size.
- Conditions
- Nursing Students
- Being tested
- Aromatherapy application
- Keywords
- skills training, nursing students, aromatherapy, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy applicationOther
Applying lemon, orange and frankincense oils via inhalation
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | Aromatherapy Group Aromatherapy will be carried out by spreading the essential oil in the laboratory with the help of a censer. For each censer, 6drops of essential oil mixture (oil mixture ratio, lemon, orange, frankincense oils; 2:2:2 ratio) and two censers will be used. Students will fill out the Introductory Information Form and State Anxiety Scale before being admitted to the laboratory. Students in the experimental group will be taken to the laboratory where aromatherapy is applied, intravenous catheter application will be demonstrated on a simulation model by the researcher during skill training, and each student will practice on the model once. At the end of the application, after students fill out the State Anxiety Scale again, they will be taken to a different room/laboratory and evaluated for skill learning. Receives: Other: Aromatherapy application |
| Control | No intervention | No Intervention: Routine practices Students will fill out the Introductory Information Form and State Anxiety Scale before being admitted to the laboratory. First, the students in the control group will be taken to the laboratory, during the skills training, the intravenous catheter application will be demonstrated on a simulation model by the researcher, and each student will practice on the model once. At the end of the application, after students fill out the State Anxiety Scale again, they will be taken to a different room/laboratory and evaluated for skill learning. The evaluation will be carried out by the researchers for each student individually and with a standard check-list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between skill learning of students in the aromatherapy group and the control group
Determining the effect of aromatherapy application on nursing students' skill scores.
Measured: immediately after intervention
Secondary outcomes (1)
Difference between anxiety levels of students in the aromatherapy group and the control group
Determining the effect of aromatherapy application on the state anxiety scale scores of nursing students.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start12 Feb 2024
- Primary completion19 Feb 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing StudentsStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Elmali Simsek, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381544
- Sponsor's protocol ID
- fbu_nurs_elmali_002
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Use in Nursing Skills Training on Learning and Anxiety Level: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06381544
- Acronym / sponsor ID
- fbu_nurs_elmali_002
- Conditions
- Nursing Students
- Keywords
- skills training, nursing students, aromatherapy, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nursing education is an education in which theory and practice are intertwined and requires the development of both cognitive and motor skills of students. The laboratory environment is a bridge between classroom learning and clinical practice. In order for students to transform the target behavior into a skill, it takes place in the laboratory on inanimate models under the supervision of the instructor. It has been assumed that there is a strong relationship between learning and anxiety; while a moderate level of anxiety is necessary for learning, a high level of anxiety causes a decrease in learning.
Many studies have reported that students experience anxiety before their first clinical/practice experience. During skills training, it is observed that students are stressed, their hands are shaking, and they do not feel comfortable, especially before practices involving invasive interventions. This is a factor that makes learning skills training difficult. Therefore, it is important for the student to be comfortable, self-confident, and mentally open to learning during skill training. New applications and different techniques for skill training are important in this sense. It is reported that aromatherapy application has positive effects on reducing anxiety and increasing concentration.
RESEARCH HYPOTHESES:
H0: Aromatherapy has no effect on students' anxiety and learning levels during skill training.
H1: Aromatherapy reduces the anxiety experienced by students during skills training.
H2: Aromatherapy has a positive effect on students' learning nursing skills.
Detailed description
The population of the research consists of 81 students enrolled in the first year of nursing. Power analysis was performed to determine the number of people to be included in the study. The power of the test was calculated with the G*Power 3.1 program. As a similar study in the relevant literature, the effect size regarding stress change was calculated as 0.760. In order to exceed the 95% value in determining the power of the study; At a significance level of 5% and an effect size of 0.760, 42 people, 21 people in the groups, need to be reached (df=20; t=1.725). To avoid bias in the people to be included in the study, they were recruited by randomization according to the order of arrival. The randomization table was created using "https://www.calculatorsoup.com". In the research, it was reached a total of 77 students (experiment=39, control=38).
Introductory Information Form, State-Trait Anxiety Inventory and IV Catheter Application Check List will be used to collect data.
In this study, it is planned to analyze the data in SPSS program. Normality tests, mean, standard deviation, minimum, maximum, number-percentage distributions in data analysis; Independent Groups t-test, Mann Whitney U test, One-Way Analysis of Variance, Kruskal-Wallis test will be used. Differences between groups in terms of categorical variables will be examined with the chi-square test. Pearson correlation analysis will be used to examine the relationships between variables, and Cohen-d effect size will be used to determine the effect size.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: Aromatherapy applicationAromatherapy Group Aromatherapy will be carried out by spreading the essential oil in the laboratory with the help of a censer. For each censer, 6drops of essential oil mixture (oil mixture ratio, lemon, orange, frankincense oils; 2:2:2 ratio) and two censers will be used. Students will fill out the Introductory Information Form and State Anxiety Scale before being admitted to the laboratory. Students in the experimental group will be taken to the laboratory where aromatherapy is applied, intravenous catheter application will be demonstrated on a simulation model by the researcher during skill training, and each student will practice on the model once. At the end of the application, after students fill out the State Anxiety Scale again, they will be taken to a different room/laboratory and evaluated for skill learning. |
| Control | No intervention | –No Intervention: Routine practices Students will fill out the Introductory Information Form and State Anxiety Scale before being admitted to the laboratory. First, the students in the control group will be taken to the laboratory, during the skills training, the intravenous catheter application will be demonstrated on a simulation model by the researcher, and each student will practice on the model once. At the end of the application, after students fill out the State Anxiety Scale again, they will be taken to a different room/laboratory and evaluated for skill learning. The evaluation will be carried out by the researchers for each student individually and with a standard check-list. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Absence of any respiratory system disease (asthma, COPD, etc.),
- Not having a cardiovascular disease,
- Not being allergic to any odor,
- Lack of pregnancy,
- Not having any obstacle to smell,
Key exclusion criteria (4 listed)
- Filling out forms incompletely,
- Not agreeing to participate in the study,
- Having previously received skills training for IV catheter application,
- Any side effects occur during application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy applicationApplying lemon, orange and frankincense oils via inhalation | Other | Aromatherapy |
Primary outcome
Difference between skill learning of students in the aromatherapy group and the control group
Time frame: immediately after intervention
Determining the effect of aromatherapy application on nursing students' skill scores.
1 secondary outcome
Difference between anxiety levels of students in the aromatherapy group and the control group
Time frame: immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy application in people with Nursing Students, run by Fenerbahce University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between skill learning of students in the aromatherapy group and the control group (time frame: immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.