- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06778876
Effect of Lavender on Sleep Quality and Insomnia Severity in Patients
Effect of Lavender on Sleep Quality and Insomnia Severity in Patients With Psychophysiological Insomnia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Keçiören
-
Ankara, Keçiören, Turkey (Türkiye), 06010
- University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: lavender sachet group
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.
|
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.
|
|
Sham Comparator: Control group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Insomnia Severity Index
Time Frame: two weeks
|
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.
|
two weeks
|
|
The Epworth Sleepiness Scale
Time Frame: two weeks
|
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.
|
two weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bülent D. Akçay, Assoc. Prof., Saglik Bilimleri Universitesi
- Principal Investigator: Mehmet Koçer, MD, Gulhane Training and Research Hospital
- Principal Investigator: Duygu Akçay, Asst.Prof, Ufuk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Mental Disorders
- Sleep Wake Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sleepiness
- Sleep Initiation and Maintenance Disorders
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Control Groups
Other Study ID Numbers
- SBU-RSH-BDA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Insomnia, Psychophysiological
-
Oregon Health and Science UniversityCompletedPrimary Insomnia | Psychophysiological InsomniaUnited States
-
Zan WangRecruiting
-
University of PittsburghCompletedSleep Disorder | Insomnia | Insomnia, PsychophysiologicalUnited States
-
Diakonhjemmet HospitalCompletedSleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Chronic Disease | Sleep Disturbance | Insomnia Chronic | Insomnia Due to Medical Condition | Insomnia, PsychophysiologicalNorway
-
Diakonhjemmet HospitalCompletedSleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep Disturbance | Mental Illness | Depression, Anxiety | Insomnia Chronic | Psychological Disorder | Insomnia Due to Mental Disorder | Insomnia, PsychophysiologicalNorway
-
Oberwaid AGUniversity of Zurich; University of Basel; Institute for Exercise and Health...CompletedDepression | Sleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Sleep Fragmentation | Insomnia Due to Other Mental Disorder | Insomnia, Psychophysiological | Insomnia Related to Another Mental ConditionSwitzerland
-
Uskudar UniversityBeykoz University; Istanbul Nisantasi UniversityRecruitingAnxiety Disorders | Generalized Anxiety Disorder (GAD) | Psychophysiological Disorders | Stress-Related DisordersTurkey
-
Bozok UniversityThe Scientific Research Project Fund of Yozgat Bozok UniversityCompletedAthletes | Sports Performance | Visual-Motor Processing | Neuro-Psychophysiological Responses in AthletesTurkey (Türkiye)
-
Oregon State UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingInsomnia, Psychophysiological | Shift Work Type Circadian Rhythm Sleep DisorderUnited States
-
Christoph NissenRecruitingInsomnia | Insomnia Chronic | Insomnia Disorder | Insomnia, Primary | Insomnia Type; Sleep Disorder | Insomnia Disorders | Insomnia, NonorganicSwitzerland
Clinical Trials on lavender sachet group
-
Alexandria UniversityNot yet recruiting
-
TC Erciyes UniversityCompletedCholecystectomy | AromatherapyTurkey
-
Mike O'Callaghan Military HospitalAmerican Academy of Family PhysiciansCompletedColposcopyUnited States
-
TC Erciyes UniversityThe Scientific and Technological Research Council of TurkeyCompleted
-
TCI Co., Ltd.Completed
-
Corlu State HospitalCompleted
-
TCI Co., Ltd.Completed
-
Ardahan UniversityRecruitingPrimary HypertensionTurkey (Türkiye)
-
Eskisehir Osmangazi UniversityCompleted