Insomnia, PsychophysiologicalNCT06778876
Effect of Lavender on Sleep Quality and Insomnia Severity in Patients
A study testing lavender sachet group in people with Insomnia, Psychophysiological, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
Today, psychophysiological insomnia is the most common persistent insomnia. Lavender essential oil is frequently used in the literature as an aromatherapy method to improve sleep quality. Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia, Psychophysiological
- What is being tested?
- lavender sachet group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2025to 12 Sep 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older,
- Being over 65 years old
- Being diagnosed with psychophysiological insomnia,
- Knowing Turkish at a level that will allow you to read and understand the survey questions,
- Accepting to participate in the study
Who cannot join
- Having a serious physical or cognitive disability that would prevent him/her from answering the survey,
- Being under the age of 18,
- Not accepting to participate in the study,
- Being allergic to lavender,
- Having a chronic additional disease related to the respiratory system,
- Having a psychiatric or neurological additional disease,
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- Using medication(s) that may affect sleep,
- Experiencing a physical activity limitation that causes bedriddenness,
- Having or contracting a disease that will affect the ability to smell.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Ankara, Keçiören, 06010
About this study
Official title: Effect of Lavender on Sleep Quality and Insomnia Severity in Patients With Psychophysiological Insomnia
Today, psychophysiological insomnia is the most common persistent insomnia. Lavender essential oil is frequently used in the literature as an aromatherapy method to improve sleep quality. Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature is reviewed, no studies examining the effects of lavender oil on patients with psychophysiological insomnia were found. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.
Read the detailed description
Today, psychophysiological insomnia is the most common persistent insomnia. The patient's inability to sleep occurs as a result of repetitive negative thoughts such as the thought that he will have difficulty sleeping before going to bed and/or past experiences involving the bedroom or the night. More effort to sleep causes more wakefulness and more difficulty falling asleep.
Numerous studies have shown that insomnia seriously affects health and quality of life and can cause various problems including memory problems, depression, irritability, cardiovascular and cerebrovascular diseases, etc. Therefore, looking for effective ways to improve sleep quality is important for individual and social health. Today, drug therapy, psychotherapy, physiotherapy and cognitive-behavioral therapy are widely used treatments for insomnia. Recently, more and more studies have found that aromatherapy is one of the non-drug treatments to improve sleep quality. Lavender essential oil appears in the literature as an aromatherapy method frequently used to improve sleep quality.
Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature was examined, no studies were found examining the effects of lavender oil on patients with psychophysiological insomnia. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.
- Conditions
- Insomnia, Psychophysiological
- Being tested
- lavender sachet group, control group
- Keywords
- insomnia, sleep quality, Sleepiness, Lavender
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lavender sachet groupOther
The normal procedure applied in the sleep clinic (keeping a sleep diary, sleep hygiene education) will be followed and participants will be asked to sleep with lavender sachets inside their pillows for two weeks.
control groupOther
Participants will follow the normal procedure applied (keeping a sleep diary, sleep hygiene training) in the sleep clinic and no additional intervention will be performed.
| Study group | Role | What they receive |
|---|---|---|
| lavender sachet group | Active comparator | The normal procedure applied in the sleep clinic (keeping a sleep diary, sleep hygiene education) will be followed and participants will be asked to sleep with lavender sachets inside their pillows for two weeks. Receives: Other: lavender sachet group |
| Control group | Sham comparator | Participants will follow the normal procedure applied (keeping a sleep diary, sleep hygiene training) in the sleep clinic and no additional intervention will be performed. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index
PSQI is a 19-item scale, assessed by self-report (19 items) and spouse/roommate responses (5 items). The scale includes components such as sleep quality, duration, and disturbance, and the total score ranges from 0 to 21; a score greater than 5 indicates poor sleep quality.
Measured: two weeks
Secondary outcomes (2)
The Insomnia Severity Index
ISS is a 7-item self-report scale. The total score obtained from this scale varies between 0 and 28, and a score of 15 and above indicates clinical insomnia.
Measured: two weeks
The Epworth Sleepiness Scale
ESS is a four-point Likert-type scale consisting of 8 items. The score range of this scale is 0 to 24, and a score of 10 and above indicates excessive daytime sleepiness.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start21 Jan 2025
- Primary completion21 Jul 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia, PsychophysiologicalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups with a control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bülent devrim akçay, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Bülent D. Akçay, Assoc. Prof., Principal investigator, Saglik Bilimleri UniversitesiMehmet Koçer, MD, Principal investigator, Gulhane Training and Research HospitalDuygu Akçay, Asst.Prof, Principal investigator, Ufuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778876
- Sponsor's protocol ID
- SBU-RSH-BDA-01
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2025
- Last updated
- 16 Sep 2025
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lavender on Sleep Quality and Insomnia Severity in Patients With Psychophysiological Insomnia
- ClinicalTrials.gov ID
- NCT06778876
- Acronym / sponsor ID
- SBU-RSH-BDA-01
- Conditions
- Insomnia, Psychophysiological
- Keywords
- insomnia, sleep quality, Sleepiness, Lavender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 16 Jan 2025 (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.
Today, psychophysiological insomnia is the most common persistent insomnia. Lavender essential oil is frequently used in the literature as an aromatherapy method to improve sleep quality. Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature is reviewed, no studies examining the effects of lavender oil on patients with psychophysiological insomnia were found. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.
Detailed description
Today, psychophysiological insomnia is the most common persistent insomnia. The patient's inability to sleep occurs as a result of repetitive negative thoughts such as the thought that he will have difficulty sleeping before going to bed and/or past experiences involving the bedroom or the night. More effort to sleep causes more wakefulness and more difficulty falling asleep.
Numerous studies have shown that insomnia seriously affects health and quality of life and can cause various problems including memory problems, depression, irritability, cardiovascular and cerebrovascular diseases, etc. Therefore, looking for effective ways to improve sleep quality is important for individual and social health. Today, drug therapy, psychotherapy, physiotherapy and cognitive-behavioral therapy are widely used treatments for insomnia. Recently, more and more studies have found that aromatherapy is one of the non-drug treatments to improve sleep quality. Lavender essential oil appears in the literature as an aromatherapy method frequently used to improve sleep quality.
Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature was examined, no studies were found examining the effects of lavender oil on patients with psychophysiological insomnia. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups with a control group.
| Arm | Type | Receives |
|---|---|---|
| lavender sachet group | Active comparator | Other: lavender sachet groupThe normal procedure applied in the sleep clinic (keeping a sleep diary, sleep hygiene education) will be followed and participants will be asked to sleep with lavender sachets inside their pillows for two weeks. |
| Control group | Sham comparator | Other: control groupParticipants will follow the normal procedure applied (keeping a sleep diary, sleep hygiene training) in the sleep clinic and no additional intervention will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being 18 years of age or older,
- Being over 65 years old
- Being diagnosed with psychophysiological insomnia,
- Knowing Turkish at a level that will allow you to read and understand the survey questions,
- Accepting to participate in the study
Key exclusion criteria (9 listed)
- Having a serious physical or cognitive disability that would prevent him/her from answering the survey,
- Being under the age of 18,
- Not accepting to participate in the study,
- Being allergic to lavender,
- Having a chronic additional disease related to the respiratory system,
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 |
|---|---|---|
| lavender sachet groupThe normal procedure applied in the sleep clinic (keeping a sleep diary, sleep hygiene education) will be followed and participants will be asked to sleep with lavender sachets inside their pillows for two weeks. | Other | lavender sachet group |
| control groupParticipants will follow the normal procedure applied (keeping a sleep diary, sleep hygiene training) in the sleep clinic and no additional intervention will be performed. | Other | Control group |
Primary outcome
The Pittsburgh Sleep Quality Index
Time frame: two weeks
PSQI is a 19-item scale, assessed by self-report (19 items) and spouse/roommate responses (5 items). The scale includes components such as sleep quality, duration, and disturbance, and the total score ranges from 0 to 21; a score greater than 5 indicates poor sleep quality.
2 secondary outcomes
The Insomnia Severity Index
Time frame: two weeks
The Epworth Sleepiness Scale
Time frame: two weeks
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 16 Sep 2025.
- 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.
Bülent D. Akçay, Assoc. Prof. principal investigator
Saglik Bilimleri Universitesi
Mehmet Koçer, MD principal investigator
Gulhane Training and Research Hospital
Duygu Akçay, Asst.Prof principal investigator
Ufuk 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 lavender sachet group in people with Insomnia, Psychophysiological, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi 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 5 inclusion and 9 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 16 Sep 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?
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?
The Pittsburgh Sleep Quality Index (time frame: two weeks). 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 16 Sep 2025.