Sleeping DisordersNCT05377697
The Effect of Lavender on Sleep and Balance
A study testing Dry lavender flower scent in people with Sleeping Disorders and Nursing, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
With aging, deterioration in sleep structure and balance occurs. In particular, individuals over the age of 65 often have sleep problems, and non-pharmacological methods used to solve this problem are much more reliable than pharmacological methods. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleeping Disorders, Nursing
- What is being tested?
- Dry lavender flower scent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Apr 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Volunteer to participate in the study.
- Working in shifts for at least three months
- Individuals who do not have a disease that would prevent research and communication will be included in the research.
Who cannot join
- Lavender allergy
- Patients with asthma, bronchitis
- Use of drug(s) that induce sleep
- Individuals who have received a medical diagnosis for attention will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lavender Scent Recommended to the Elderly on Sleep Quality and Physical Balance
With aging, deterioration in sleep structure and balance occurs. In particular, individuals over the age of 65 often have sleep problems, and non-pharmacological methods used to solve this problem are much more reliable than pharmacological methods. It is important for nurses who contribute most to their care to regulate and facilitate sleep, which is one of the basic needs of people. Thanks to this study, it is planned to solve the sleep-related problems of elderly individuals by using the sedative and relaxing effect of the lavender plant, which is used in many areas, thus increasing their quality of life, and it is planned to prevent falls by increasing their physical balance controls. This study aims to determine the effect of lavender scent recommended for the elderly in Konya on sleep quality and physical balance. This research is a randomized experimental design with pretest-posttest control group. The research is planned to be carried out between January 2023 and November 2023. The population of the research consists of elderly individuals living in society. In order to determine the sample size, power
analysis will be made using the G-Power (v3.1.9.2) program. Personal Information Form and Pittsburgh Sleep Quality Index will be used in
Read more
data collection. The data obtained as a result of the research; It will be analyzed with IBM SPSS program. p<0.05 will be considered statistically
significant.
Read the detailed description
The research data is planned to be collected between January 2023 and November 2023. Data will be collected from elderly individuals from the community. After the elderly individuals who meet the appropriate criteria are informed about the research, their verbal and written consent will be obtained that they agree to participate in the research.
Experimental Group In order to collect the pre-test data of the experimental group, individuals who accept the study will be asked to fill in the Personal Information Form, Sleep Quality Scale and Berg Balance Scale. The forms will be collected after the individuals mark the options closest to them on the forms. It is planned to last approximately 25-30 minutes. It is planned to recommend lavender scent as a nursing intervention to improve sleep quality in individuals with irregular sleep and low sleep quality. Participants in the experimental group will be informed about the effects of lavender scent on sleep and will be given lavender pouches. They will be informed that they should put these lavender pouches in their pillows where they sleep every day and that they should sleep with the lavender pouch for the next month, and that they should not make any changes in their rooms or beds other than the lavender pouch. After the one-month lavender scent application of the experimental group is completed, the post-test data will be collected for the experimental group. After the individuals who gave the closest answer to themselves completed the forms, the post-test data will be collected and the data collection phase of the research will be completed.
Control Group The study will start by collecting the pre-test data of the control group. Individuals who agree to participate in the study will be asked to fill in the Personal Information Form, Sleep Quality Scale and Berg Balance Scale to collect pre-test data. The forms will be collected after the individuals mark the options closest to them on the forms. After collecting the pre-test data, no intervention will be made to the participants for one month. At the end of one month, the control group will be administered the post-test with the same data collection tools.
- Conditions
- Sleeping Disorders, Nursing
- Being tested
- Dry lavender flower scent
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry lavender flower scentOther
Participants in the experimental group will be informed about the effects of lavender scent on sleep and lavender sachets will be given. They will be informed that they should put these lavender sachets in their pillows every day and sleep with a lavender sachet for the next month, and that they should not make any changes in their rooms or beds other than the lavender sachet.
| Study group | Role | What they receive |
|---|---|---|
| Lavender group | Experimental | Participants in the experimental group were informed about the effects of lavender scent on sleep and were given lavender sachets. They were instructed to place these lavender sachets on their pillows every day and to sleep with the lavender sachets for the following month, and were advised not to make any changes to their rooms or beds other than the lavender sachets. Receives: Other: Dry lavender flower scent |
| Control group | No intervention | No intervention was made to the participants in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality İndex (PSQI)
The total score has a value between 0-21, a high total score indicates poor sleep quality. A total PSQI score of less than 5 indicates the good sleep quality and a score of more than 5 indicates the poor sleep quality
Measured: Pretest (measurement taken during the initial encounter)
Berg Balance Scala (BBS)
Items include daily activities such as static sitting and standing balance, as well as transferring, turning, picking up objects, etc. Each item is rated on a scale of 0 to 4. The maximum total score is 56. A high score indicates good balance.
Measured: Pretest (measurement taken during the initial encounter)
Secondary outcomes (2)
Pittsburgh Sleep Quality İndex (PSQI)
The total score has a value between 0-21, a high total score indicates poor sleep quality. A total PSQI score of less than 5 indicates the good sleep quality and a score of more than 5 indicates the poor sleep quality.
Measured: Posttest (measurement one month after the pre-test)
Berg Balance Scala (BBS)
Items include daily activities such as static sitting and standing balance, as well as transferring, turning, picking up objects, etc. Each item is rated on a scale of 0 to 4. The maximum total score is 56. A high score indicates good balance.
Measured: Posttest (measurement one month after the pre-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start23 Apr 2022
- Primary completion30 Jul 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleeping DisordersStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berna Bayır, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377697
- Sponsor's protocol ID
- KaratayUBB
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozcihan H, Bayir B. The effect of lavender scent recommended to the elderly on sleep quality and physical balance: A randomized controlled trial. Geriatr Nurs. 2026 Aug 20;73:104248. doi: 10.1016/j.gerinurse.2026.104248. Online ahead of print.
PubMed 42623910
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lavender Scent Recommended to the Elderly on Sleep Quality and Physical Balance
- ClinicalTrials.gov ID
- NCT05377697
- Acronym / sponsor ID
- KaratayUBB
- Conditions
- Sleeping Disorders, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 23 Apr 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With aging, deterioration in sleep structure and balance occurs. In particular, individuals over the age of 65 often have sleep problems, and non-pharmacological methods used to solve this problem are much more reliable than pharmacological methods. It is important for nurses who contribute most to their care to regulate and facilitate sleep, which is one of the basic needs of people. Thanks to this study, it is planned to solve the sleep-related problems of elderly individuals by using the sedative and relaxing effect of the lavender plant, which is used in many areas, thus increasing their quality of life, and it is planned to prevent falls by increasing their physical balance controls. This study aims to determine the effect of lavender scent recommended for the elderly in Konya on sleep quality and physical balance. This research is a randomized experimental design with pretest-posttest control group. The research is planned to be carried out between January 2023 and November 2023. The population of the research consists of elderly individuals living in society. In order to determine the sample size, power
analysis will be made using the G-Power (v3.1.9.2) program. Personal Information Form and Pittsburgh Sleep Quality Index will be used in
data collection. The data obtained as a result of the research; It will be analyzed with IBM SPSS program. p<0.05 will be considered statistically
significant.
Detailed description
The research data is planned to be collected between January 2023 and November 2023. Data will be collected from elderly individuals from the community. After the elderly individuals who meet the appropriate criteria are informed about the research, their verbal and written consent will be obtained that they agree to participate in the research.
Experimental Group In order to collect the pre-test data of the experimental group, individuals who accept the study will be asked to fill in the Personal Information Form, Sleep Quality Scale and Berg Balance Scale. The forms will be collected after the individuals mark the options closest to them on the forms. It is planned to last approximately 25-30 minutes. It is planned to recommend lavender scent as a nursing intervention to improve sleep quality in individuals with irregular sleep and low sleep quality. Participants in the experimental group will be informed about the effects of lavender scent on sleep and will be given lavender pouches. They will be informed that they should put these lavender pouches in their pillows where they sleep every day and that they should sleep with the lavender pouch for the next month, and that they should not make any changes in their rooms or beds other than the lavender pouch. After the one-month lavender scent application of the experimental group is completed, the post-test data will be collected for the experimental group. After the individuals who gave the closest answer to themselves completed the forms, the post-test data will be collected and the data collection phase of the research will be completed.
Control Group The study will start by collecting the pre-test data of the control group. Individuals who agree to participate in the study will be asked to fill in the Personal Information Form, Sleep Quality Scale and Berg Balance Scale to collect pre-test data. The forms will be collected after the individuals mark the options closest to them on the forms. After collecting the pre-test data, no intervention will be made to the participants for one month. At the end of one month, the control group will be administered the post-test with the same data collection tools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavender group | Experimental | Other: Dry lavender flower scentParticipants in the experimental group were informed about the effects of lavender scent on sleep and were given lavender sachets. They were instructed to place these lavender sachets on their pillows every day and to sleep with the lavender sachets for the following month, and were advised not to make any changes to their rooms or beds other than the lavender sachets. |
| Control group | No intervention | –No intervention was made to the participants in the control group. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Volunteer to participate in the study.
- Working in shifts for at least three months
- Individuals who do not have a disease that would prevent research and communication will be included in the research.
Key exclusion criteria (4 listed)
- Lavender allergy
- Patients with asthma, bronchitis
- Use of drug(s) that induce sleep
- Individuals who have received a medical diagnosis for attention will not be included in the study.
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 |
|---|---|---|
| Dry lavender flower scentParticipants in the experimental group will be informed about the effects of lavender scent on sleep and lavender sachets will be given. They will be informed that they should put these lavender sachets in their pillows every day and sleep with a lavender sachet for the next month, and that they should not make any changes in their rooms or beds other than the lavender sachet. | Other | Lavender group |
Primary outcome
Pittsburgh Sleep Quality İndex (PSQI)
Time frame: Pretest (measurement taken during the initial encounter)
The total score has a value between 0-21, a high total score indicates poor sleep quality. A total PSQI score of less than 5 indicates the good sleep quality and a score of more than 5 indicates the poor sleep quality
Berg Balance Scala (BBS)
Time frame: Pretest (measurement taken during the initial encounter)
Items include daily activities such as static sitting and standing balance, as well as transferring, turning, picking up objects, etc. Each item is rated on a scale of 0 to 4. The maximum total score is 56. A high score indicates good balance.
2 secondary outcomes
Pittsburgh Sleep Quality İndex (PSQI)
Time frame: Posttest (measurement one month after the pre-test)
Berg Balance Scala (BBS)
Time frame: Posttest (measurement one month after the pre-test)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42623910Ozcihan H, Bayir B. The effect of lavender scent recommended to the elderly on sleep quality and physical balance: A randomized controlled trial. Geriatr Nurs. 2026 Aug 20;73:104248. doi: 10.1016/j.gerinurse.2026.104248. Online ahead of print.
- 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.
Berna Bayır principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry lavender flower scent in people with Sleeping Disorders and Nursing, run by KTO Karatay 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 3 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 20 Aug 2026. 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. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pittsburgh Sleep Quality İndex (PSQI) (time frame: Pretest (measurement taken during the initial encounter)). The study lists 2 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 NCT05377697, 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 20 Aug 2026.