AromatherapyNCT06474793
Aromatherapy Applied to Intensive Care Nurses Effect on Fatigue and Sleep Quality
A study testing Aromatherapy Intervention Group-1 and Aromatherapy Intervention Group-2 in people with Aromatherapy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
TSummary Project Scope: This study aimed to determine the effect of aromatherapy applied to intensive care nurses on fatigue and sleep quality. Method: The research will be carried out in two stages, qualitative and quantitative, to determine the effect of aromatherapy applied to intensive care nurses on fatigue and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aromatherapy
- What is being tested?
- Aromatherapy Intervention Group-1 and Aromatherapy Intervention Group-2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Not pregnant
- Understands and speaks Turkish
- No hearing or visual impairment
- Without chronic disease
- Not allergic to odors,
- Sleeping pill non-user
Show all 12Show fewer
- Nurses who work the same shifts
- They will not change the perfume used within a month.
- Complaints of moderate and severe fatigue (Visual Analog Scale (VAS) fatigue score of 3 on a scale score between 0-10),
- Pittsburg Sleep Quality Scale score of 5 and above,
- Not diagnosed with psychiatric disease
- Those who volunteer to participate in the study will be recruited.
Who cannot join
- Those who are allergic to lavender oil,
- Those who are allergic to chamomile oil,
- Those who have a disability in smelling
- Those on annual leave and sick leave,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri City Hospital
Kayseri, Kocasinan, 38010
Fatma Gönül BURKEV, 05071549118
Fatma Gönül BURKEV, Phd.Student
About this study
TSummary Project Scope: This study aimed to determine the effect of aromatherapy applied to intensive care nurses on fatigue and sleep quality.
Method: The research will be carried out in two stages, qualitative and quantitative, to determine the effect of aromatherapy applied to intensive care nurses on fatigue and sleep quality.
Read more
Quantitative Phase of the Research; The application areas and duration of massage will be explained practically by the researcher. Nurses experiencing fatigue and sleep problems in the intensive care unit were treated once a day, 30 minutes before going to bed, for a total of 8 minutes, 4 minutes at the edges of the right and left nostrils, and 4 minutes behind the right and left ears. , for four weeks. It is a randomized controlled, single-blind study conducted to determine the effect of 3% chamomile and 3% lavender oil mixture in the intervention-2 group and 3% vetiver oil in the intervention-2 group on fatigue and sleep quality. Individuals in the placebo control group will be massaged with jojoba oil.
Data in the study; It will be collected with the Personal Information Form, Visual Analogue Scale (VAS), Piper Fatigue Scale, pittsburgh Sleep Quality Index, Practice Monitoring Schedule-Researcher Form, Practice Monitoring Schedule and Nurse Form (Visual Analog Scale/VAS Scale) and Oil Application. Nurse Opinion Form.
The universe of the research; It will consist of 260 intensive care nurses working on the same shifts in the intensive care units of SBÜ Kayseri City Training and Research Hospital, located in the city center of Kayseri.
The sample size of the study was initially determined as 60 people in total, including 20 people in the intervention group-1, 20 people in the intervention group-2 and 20 people in the placebo group. Taking into account the research data, the selection of people will continue until the sufficient number is reached according to the results of statistical power analysis.
Qualitative phase of the research; At the end of the four-week application, it will be carried out with a total of 15 people, 5 from the intervention-1, intervention-2 and placebo-control groups. Interviews will continue until data saturation is reached.
As a result of the research, it is expected that the fatigue and sleep problems of the individuals in the intervention groups will improve and their sleep quality will increase.
Read the detailed description
In the research planned as mixed design, qualitative and quantitative type; In the quantitative section, 3% massage was applied to patients with IBD who have fatigue and sleep problems, once a day, 30 minutes before going to bed, for a total of 8 minutes, including 4 minutes on the edges of the right and left nostrils and 4 minutes behind the right and left ears, for four weeks. A randomized controlled trial will be conducted to determine the effect of a mixture of chamomile and 3% lavender oil and 3% vetiver oil on fatigue and sleep quality levels.
The effects of the oil mixture application shown by the researcher and applied by the nurses during the study, Assoc. Dr. Ali Çetinkaya and Dr. It will be carried out under the medical support/supervision of Ali Saz.
In the qualitative part of the research, it was planned using in-depth interview method and semi-structured survey before and after the aromatherapy massage applied to the earlobes and neck muscles for three weeks to the nurses in the intervention group.
- Conditions
- Aromatherapy
- Being tested
- Aromatherapy Intervention Group-1, Aromatherapy Intervention Group-2, Aromatherapy Placebo Control Group
- Keywords
- Nursing, Aromatherapy, Sleep, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy Intervention Group-1Other
For four weeks, once a day, 30 minutes before going to bed, a mixture of 3% chamomile and 3% lavender oil, diluted with 2% jojoba oil, is dropped into the palm of the palm of 2 ml, and after rubbing the hands together, rub the right and left nose for 4 minutes. It is the group that massages the edges of the hole with the index finger in circular movements from top to bottom, and then drops 2 ml of the oil mixture into the palm of the hand, rubs the hands mutually, and gently massages the edges of the ear with the index finger in circular movements from top to bottom behind the right and left ears for 4 minutes.
Aromatherapy Intervention Group-2Other
For four weeks, once a day, 30 minutes before going to bed, 3% vetiver oil diluted with 2% jojoba oil is dropped into the palm of the palm of 2 ml, and after rubbing the hands together, rub the edges of the right and left nostrils from top to bottom with the index finger for four minutes. It is a group where massage is applied with a massager and then 2 ml of the oil mixture is dropped into the palm of the hand, the hands are rubbed mutually, and then a gentle massage is applied behind the right and left ears with circular movements from top to bottom for 4 minutes.
Aromatherapy Placebo Control GroupOther
For four weeks, once a day, 30 minutes before going to bed, 2 ml of jojoba oil is dropped into the palm of the hand and after rubbing the hands mutually, massage the edges of the right and left nostril with circular movements from top to bottom with the index finger for four minutes and apply jojoba oil to the palm again. It is a group in which 2 ml is dropped and the hands are rubbed together and then gently massaged behind the right and left ears with circular movements from top to bottom for 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy Intervention Group-1 | Active comparator | Participants in the Intervention-1 group will apply a 2 ml mixture of 3% chamomile and 3% lavender oil diluted with 2% jojoba oil, dropped into the palm and rubbed into the palm.. Receives: Other: Aromatherapy Intervention Group-1 |
| Aromatherapy Intervention Group-2 | Active comparator | Participants in the intervention-2 group will use a mixture of 3% vetiver oil diluted with 2% jojoba oil by dropping 2 ml into the palm. Receives: Other: Aromatherapy Intervention Group-2 |
| Aromatherapy Placebo Control Group | Placebo comparator | Participants in the placebo control group will apply by dropping 2 ml of jojoba oil. Receives: Other: Aromatherapy Placebo Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) -Fatigue
Nurses experiencing fatigue will be asked to mark the point on the VAS that will accurately reflect the severity of fatigue felt at that moment by explaining the scale as "0" meaning I do not feel tired and "10" meaning "I feel very tired". The distance between the point marked by the nurses themselves and the starting point "0" will be measured using a ruler. The distance measurement will be measured in millimeters and will be evaluated as a "fatigue score".
Measured: up to 3 months
Piper Fatigue Scale
It consists of 27 items in total. Scale score calculation; The scores of the sub-dimensions are divided by the number of items by adding up the scores of all items in each sub-dimension. In calculating the total fatigue score; It is obtained by adding 22 item scores and dividing by the number of items. High scores obtained from the scale indicate that perceived fatigue is at a high level. The Turkish validity and reliability study of the scale was conducted by Can (2001) and the Cronbach's alpha coefficient was reported as 0.94.
Measured: up to 3 months
Pittsburg Sleep Quality Index (PUKI)
In calculating the total PSQI score, a value between 0-21 is obtained by summing the subscales. In total score evaluation; It is evaluated as "5-6= 3 points", "3-4= 2 points", "1-2= 1 point" and "0= 0 points". High scores from the scale indicate poor sleep quality. If the PSQI total score is between 0 and 4, it is defined as "good" sleep quality, and if it is 5 or more, it is considered as "poor" sleep quality.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start15 Jun 2025 (estimated)
- Primary completion28 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AromatherapyStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Gonul Burkev, TC Erciyes University
- Investigators
- Sultan TAŞCI, Prof.Dr., Study director, Erciyes Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474793
- Sponsor's protocol ID
- 10631029
- Status last verified
- May 2025
- First submitted
- 11 Jun 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burkev FG, Tasci S, Cetinkaya A, Aktas E. The Effect of Aromatherapy on Fatigue and Sleep Quality in Intensive Care Nurses: A Randomised Placebo-Controlled Trial. Nurs Crit Care. 2026 Sep;31(5):e70602. doi: 10.1111/nicc.70602.
PubMed 42630137
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy Applied to Intensive Care Nurses Effect on Fatigue and Sleep Quality
- ClinicalTrials.gov ID
- NCT06474793
- Acronym / sponsor ID
- 10631029
- Conditions
- Aromatherapy
- Keywords
- Nursing, Aromatherapy, Sleep, Fatigue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 28 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Jun 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.
TSummary Project Scope: This study aimed to determine the effect of aromatherapy applied to intensive care nurses on fatigue and sleep quality.
Method: The research will be carried out in two stages, qualitative and quantitative, to determine the effect of aromatherapy applied to intensive care nurses on fatigue and sleep quality.
Quantitative Phase of the Research; The application areas and duration of massage will be explained practically by the researcher. Nurses experiencing fatigue and sleep problems in the intensive care unit were treated once a day, 30 minutes before going to bed, for a total of 8 minutes, 4 minutes at the edges of the right and left nostrils, and 4 minutes behind the right and left ears. , for four weeks. It is a randomized controlled, single-blind study conducted to determine the effect of 3% chamomile and 3% lavender oil mixture in the intervention-2 group and 3% vetiver oil in the intervention-2 group on fatigue and sleep quality. Individuals in the placebo control group will be massaged with jojoba oil.
Data in the study; It will be collected with the Personal Information Form, Visual Analogue Scale (VAS), Piper Fatigue Scale, pittsburgh Sleep Quality Index, Practice Monitoring Schedule-Researcher Form, Practice Monitoring Schedule and Nurse Form (Visual Analog Scale/VAS Scale) and Oil Application. Nurse Opinion Form.
The universe of the research; It will consist of 260 intensive care nurses working on the same shifts in the intensive care units of SBÜ Kayseri City Training and Research Hospital, located in the city center of Kayseri.
The sample size of the study was initially determined as 60 people in total, including 20 people in the intervention group-1, 20 people in the intervention group-2 and 20 people in the placebo group. Taking into account the research data, the selection of people will continue until the sufficient number is reached according to the results of statistical power analysis.
Qualitative phase of the research; At the end of the four-week application, it will be carried out with a total of 15 people, 5 from the intervention-1, intervention-2 and placebo-control groups. Interviews will continue until data saturation is reached.
As a result of the research, it is expected that the fatigue and sleep problems of the individuals in the intervention groups will improve and their sleep quality will increase.
Detailed description
In the research planned as mixed design, qualitative and quantitative type; In the quantitative section, 3% massage was applied to patients with IBD who have fatigue and sleep problems, once a day, 30 minutes before going to bed, for a total of 8 minutes, including 4 minutes on the edges of the right and left nostrils and 4 minutes behind the right and left ears, for four weeks. A randomized controlled trial will be conducted to determine the effect of a mixture of chamomile and 3% lavender oil and 3% vetiver oil on fatigue and sleep quality levels.
The effects of the oil mixture application shown by the researcher and applied by the nurses during the study, Assoc. Dr. Ali Çetinkaya and Dr. It will be carried out under the medical support/supervision of Ali Saz.
In the qualitative part of the research, it was planned using in-depth interview method and semi-structured survey before and after the aromatherapy massage applied to the earlobes and neck muscles for three weeks to the nurses in the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy Intervention Group-1 | Active comparator | Other: Aromatherapy Intervention Group-1Participants in the Intervention-1 group will apply a 2 ml mixture of 3% chamomile and 3% lavender oil diluted with 2% jojoba oil, dropped into the palm and rubbed into the palm.. |
| Aromatherapy Intervention Group-2 | Active comparator | Other: Aromatherapy Intervention Group-2Participants in the intervention-2 group will use a mixture of 3% vetiver oil diluted with 2% jojoba oil by dropping 2 ml into the palm. |
| Aromatherapy Placebo Control Group | Placebo comparator | Other: Aromatherapy Placebo Control GroupParticipants in the placebo control group will apply by dropping 2 ml of jojoba oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Not pregnant
- Understands and speaks Turkish
- No hearing or visual impairment
- Without chronic disease
- Not allergic to odors,
Key exclusion criteria (4 listed)
- Those who are allergic to lavender oil,
- Those who are allergic to chamomile oil,
- Those who have a disability in smelling
- Those on annual leave and sick leave,
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 Intervention Group-1For four weeks, once a day, 30 minutes before going to bed, a mixture of 3% chamomile and 3% lavender oil, diluted with 2% jojoba oil, is dropped into the palm of the palm of 2 ml, and after rubbing the hands together, rub the right and left nose for 4 minutes. It is the group that massages the edges of the hole with the index finger in circular movements from top to bottom, and then drops 2 ml of the oil mixture into the palm of the hand, rubs the hands mutually, and gently massages the edges of the ear with the index finger in circular movements from top to bottom behind the right and left ears for 4 minutes. | Other | Aromatherapy Intervention Group-1 |
| Aromatherapy Intervention Group-2For four weeks, once a day, 30 minutes before going to bed, 3% vetiver oil diluted with 2% jojoba oil is dropped into the palm of the palm of 2 ml, and after rubbing the hands together, rub the edges of the right and left nostrils from top to bottom with the index finger for four minutes. It is a group where massage is applied with a massager and then 2 ml of the oil mixture is dropped into the palm of the hand, the hands are rubbed mutually, and then a gentle massage is applied behind the right and left ears with circular movements from top to bottom for 4 minutes. | Other | Aromatherapy Intervention Group-2 |
| Aromatherapy Placebo Control GroupFor four weeks, once a day, 30 minutes before going to bed, 2 ml of jojoba oil is dropped into the palm of the hand and after rubbing the hands mutually, massage the edges of the right and left nostril with circular movements from top to bottom with the index finger for four minutes and apply jojoba oil to the palm again. It is a group in which 2 ml is dropped and the hands are rubbed together and then gently massaged behind the right and left ears with circular movements from top to bottom for 4 minutes. | Other | Aromatherapy Placebo Control Group |
Primary outcome
Visual Analog Scale (VAS) -Fatigue
Time frame: up to 3 months
Nurses experiencing fatigue will be asked to mark the point on the VAS that will accurately reflect the severity of fatigue felt at that moment by explaining the scale as "0" meaning I do not feel tired and "10" meaning "I feel very tired". The distance between the point marked by the nurses themselves and the starting point "0" will be measured using a ruler. The distance measurement will be measured in millimeters and will be evaluated as a "fatigue score".
Piper Fatigue Scale
Time frame: up to 3 months
It consists of 27 items in total. Scale score calculation; The scores of the sub-dimensions are divided by the number of items by adding up the scores of all items in each sub-dimension. In calculating the total fatigue score; It is obtained by adding 22 item scores and dividing by the number of items. High scores obtained from the scale indicate that perceived fatigue is at a high level. The Turkish validity and reliability study of the scale was conducted by Can (2001) and the Cronbach's alpha coefficient was reported as 0.94.
Pittsburg Sleep Quality Index (PUKI)
Time frame: up to 3 months
In calculating the total PSQI score, a value between 0-21 is obtained by summing the subscales. In total score evaluation; It is evaluated as "5-6= 3 points", "3-4= 2 points", "1-2= 1 point" and "0= 0 points". High scores from the scale indicate poor sleep quality. If the PSQI total score is between 0 and 4, it is defined as "good" sleep quality, and if it is 5 or more, it is considered as "poor" sleep quality.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 42630137Burkev FG, Tasci S, Cetinkaya A, Aktas E. The Effect of Aromatherapy on Fatigue and Sleep Quality in Intensive Care Nurses: A Randomised Placebo-Controlled Trial. Nurs Crit Care. 2026 Sep;31(5):e70602. doi: 10.1111/nicc.70602.
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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.
Sultan TAŞCI, Prof.Dr. study director
Erciyes Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy Intervention Group-1 and Aromatherapy Intervention Group-2 in people with Aromatherapy, run by TC Erciyes University at 1 site 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 12 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: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BURKEV (05071549118, fatmaburkev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) -Fatigue (time frame: up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06474793, which also lists 1 linked publication.
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 22 May 2025.