Hematologic MalignanciesNCT05808296
The Effect of Lavender Oil on Fatigue and Sleep Quality
A study testing Lavander oil Aromatherapy and Saline Solution in people with Hematologic Malignancies and Patient Participation, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
This study will be conducted in a randomized, controlled and experimental manner with patients with hematological malignancies admitted to the Adult Bone Marrow Transplant unit and Hematology-Oncology unit of Acıbadem Altunizade Hospital after obtaining the necessary permissions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancies, Patient Participation
- What is being tested?
- Lavander oil Aromatherapy and Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Apr 2023
- 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
- Accepting to participate in the study and being 18 years of age or older
- Cooperation, no communication problems
- Systolic blood pressure above 100 mmHg (lavender can cause hypotension)
- Staying in the bone marrow transplant service for at least two days
Who cannot join
- Known diagnosis of a psychiatric illness (anxiety, panic attacks, depression), a known history of allergy and use of anxiolytic drugs.
- Having arrhythmia
- Do not use sleeping pills
- Allergy to any essential oil
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dilek Yildirim
Istanbul, Küçükçekmece
DİLEK YILDIRIM, PHD, 444 1 428 ext. 20114, dilekaticiyildirim@gmail.com
About this study
Official title: The Effect of Lavender Oil on Fatigue and Sleep Quality in Patients With Hematologic Malignancy: A Single Blinding Randomized Controlled Study
This study will be conducted in a randomized, controlled and experimental manner with patients with hematological malignancies admitted to the Adult Bone Marrow Transplant unit and Hematology-Oncology unit of Acıbadem Altunizade Hospital after obtaining the necessary permissions. The number of patients to be included in the study will be determined by power analysis. The study will include patients who are willing to participate, have no communication problems, are 18 years of age or older, and have no known allergy to lavender oil. Patients with allergies, drug addiction and refusal to participate in the study will not be included in the study. Before the study, patients will be divided into intervention and control groups using a simple random number table. At the beginning of the study, a form including socio-demographic and disease information, Richard Campbell Sleep Quality Scale and Piper Fatigue Scale will be evaluated. Two different options will be used to prevent findings. The first group will be treated with lavender oil and the second group will be treated with saline and 2 drops will be placed on the patient's shoulder 20 minutes before bedtime every night. The application will be started simultaneously with the chemotherapy and will continue until the end of chemotherapy treatment. Sleep and fatigue will be assessed daily using the Richard Campbell Sleep Quality Scale and Piper Fatigue Scale.
Read the detailed description
Insomnia and fatigue symptoms, which are common in patients with hematologic malignancies, affect the quality of life of patients and may increase the severity of other symptoms. Pharmacologic and non-pharmacologic methods can be used in the management of insomnia and fatigue. Nonpharmacologic approaches are also used because pharmacologic methods have side effects and their effects on sleep and fatigue are not fully proven. One of the nonpharmacological approaches used is lavender oil inhalation. The effects of lavender oil on sleep and fatigue have been shown in studies. In addition, no national or international study results evaluating the effect of lavender oil on fatigue and sleep quality in patients with hematologic malignancy were found in the literature. Based on this, the study was planned to examine the effect of lavender oil on sleep quality and vital signs of palliative care patients.
This study will be conducted in a randomized, controlled and experimental manner with patients with hematological malignancies admitted to the Adult Bone Marrow Transplant unit and Hematology-Oncology unit of Acıbadem Altunizade Hospital after obtaining the necessary permissions. The number of patients to be included in the study will be determined by power analysis. The study will include patients who are willing to participate, have no communication problems, are 18 years of age or older, and have no known allergy to lavender oil. Patients with allergies, drug addiction and refusal to participate in the study will not be included in the study. Before the study, patients will be divided into intervention and control groups using a simple random number table. At the beginning of the study, a form including socio-demographic and disease information, Richard Campbell Sleep Quality Scale and Piper Fatigue Scale will be evaluated. Two different options will be used to prevent findings. The first group will be treated with lavender oil and the second group will be treated with saline and 2 drops will be placed on the patient's shoulder 20 minutes before bedtime every night. The application will be started simultaneously with the chemotherapy and will continue until the end of chemotherapy treatment. Sleep and fatigue will be assessed daily using the Richard Campbell Sleep Quality Scale and Piper Fatigue Scale.
Statistical Package for Social Science (SPSS) statistical package program will be used in the evaluation of the data, the conformity of the data to normal distribution will be questioned with Kollmogorov Smirnov test, mean, standard deviation, correlation values will be examined and T-Test will be used to evaluate the relationship between independent groups.
- Conditions
- Hematologic Malignancies, Patient Participation
- Being tested
- Lavander oil Aromatherapy, Saline Solution
- Keywords
- Sleep Disorders, Aroma Therapy, Hematologic Malignancies, Fatigue
- Medical subject headings
- Hematologic Neoplasms, Patient Participation, Sleep Wake Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavander oil AromatherapyOther
Lavander oil Aromatherapy
Saline SolutionOther
Saline solution application
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | aromatherapy will be performed by dropping 2 drops of lavender oil on the shoulder with a sponge 20 minutes before bedtime every night for a week Receives: Other: Lavander oil Aromatherapy |
| Control | Sham comparator | Saline solution will be performed by dropping 2 drops of saline solution on the shoulder with a sponge 20 minutes before bedtime every night for a week Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive information form
The form includes demographic data such as age, gender and education level
Measured: 1. day.
Richards Campbell Sleep Quality Scale (RCSQ)
The sleep quality of the patients was evaluated three times with the Richards Campbell Sleep Quality Scale: preintervention, postintervention day 1 and postintervention day 2. The Richards Campbell Sleep Quality Scale consists of six items evaluating the depth of the patients' night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level in the environment. Each item is evaluated by the patient by questioning the patient's night sleep on a visual analog scale of 0-100. The total score of the scale is obtained from the sum of the five items. The 6th item evaluating the ambient noise level is excluded from the total score evaluation. A score between "0-25" indicates that the quality of the patient's night sleep is very poor and a score between "76-100" indicates that the quality of the patient's night sleep is very good.
Measured: 1. day
Richards Campbell Sleep Quality Scale (RCSQ)
The sleep quality of the patients was evaluated three times with the Richards Campbell Sleep Quality Scale: preintervention, postintervention day 1 and postintervention day 2. The Richards Campbell Sleep Quality Scale consists of six items evaluating the depth of the patients' night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level in the environment. Each item is evaluated by the patient by questioning the patient's night sleep on a visual analog scale of 0-100. The total score of the scale is obtained from the sum of the five items. The 6th item evaluating the ambient noise level is excluded from the total score evaluation. A score between "0-25" indicates that the quality of the patient's night sleep is very poor and a score between "76-100" indicates that the quality of the patient's night sleep is very good.
Measured: 7. day
Piper Fatigue Scale
The scale developed by Piper B. F. et al. in 1998 consists of a total of 22 items and evaluates the patient's subjective perception of fatigue with four sub-dimensions. These are the behavior/severity sub-dimension (6 items; 2-7), which evaluates the impact and severity of fatigue on activities of daily living (ADL); the affect sub-dimension (5 items; 8-12), which covers the emotional meaning attributed to fatigue; the sensory sub-dimension (5 items; 13-17), which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/mental sub-dimension (6 items; 18-23), which reflects the level of fatigue affecting cognitive functions and mental state. In addition, there are 5 items (1 and 24-27).
Measured: 1. day
Piper Fatigue Scale
The scale developed by Piper B. F. et al. in 1998 consists of a total of 22 items and evaluates the patient's subjective perception of fatigue with four sub-dimensions. These are the behavior/severity sub-dimension (6 items; 2-7), which evaluates the impact and severity of fatigue on activities of daily living (ADL); the affect sub-dimension (5 items; 8-12), which covers the emotional meaning attributed to fatigue; the sensory sub-dimension (5 items; 13-17), which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/mental sub-dimension (6 items; 18-23), which reflects the level of fatigue affecting cognitive functions and mental state. In addition, there are 5 items (1 and 24-27).
Measured: 7. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Jan 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (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 Hematologic MalignanciesStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLEK YILDIRIM, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808296
- Sponsor's protocol ID
- Lavender Oil on Hematological
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yildirim D, Harman Ozdogan M, Erdal S, Selcuk S, Guneri A, Simsek EB, Can TB, Gunduz H, Kuni A. The efficacy of lavender oil on fatigue and sleep quality in patients with hematological malignancy receiving chemotherapy: a single-blind randomized controlled trial. Support Care Cancer. 2025 Jan 8;33(2):79. doi: 10.1007/s00520-024-09143-5.
PubMed 39775962
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lavender Oil on Fatigue and Sleep Quality in Patients With Hematologic Malignancy: A Single Blinding Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05808296
- Acronym / sponsor ID
- Lavender Oil on Hematological
- Conditions
- Hematologic Malignancies, Patient Participation
- Keywords
- Sleep Disorders, Aroma Therapy, Hematologic Malignancies, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 11 Apr 2023 (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.
This study will be conducted in a randomized, controlled and experimental manner with patients with hematological malignancies admitted to the Adult Bone Marrow Transplant unit and Hematology-Oncology unit of Acıbadem Altunizade Hospital after obtaining the necessary permissions. The number of patients to be included in the study will be determined by power analysis. The study will include patients who are willing to participate, have no communication problems, are 18 years of age or older, and have no known allergy to lavender oil. Patients with allergies, drug addiction and refusal to participate in the study will not be included in the study. Before the study, patients will be divided into intervention and control groups using a simple random number table. At the beginning of the study, a form including socio-demographic and disease information, Richard Campbell Sleep Quality Scale and Piper Fatigue Scale will be evaluated. Two different options will be used to prevent findings. The first group will be treated with lavender oil and the second group will be treated with saline and 2 drops will be placed on the patient's shoulder 20 minutes before bedtime every night. The application will be started simultaneously with the chemotherapy and will continue until the end of chemotherapy treatment. Sleep and fatigue will be assessed daily using the Richard Campbell Sleep Quality Scale and Piper Fatigue Scale.
Detailed description
Insomnia and fatigue symptoms, which are common in patients with hematologic malignancies, affect the quality of life of patients and may increase the severity of other symptoms. Pharmacologic and non-pharmacologic methods can be used in the management of insomnia and fatigue. Nonpharmacologic approaches are also used because pharmacologic methods have side effects and their effects on sleep and fatigue are not fully proven. One of the nonpharmacological approaches used is lavender oil inhalation. The effects of lavender oil on sleep and fatigue have been shown in studies. In addition, no national or international study results evaluating the effect of lavender oil on fatigue and sleep quality in patients with hematologic malignancy were found in the literature. Based on this, the study was planned to examine the effect of lavender oil on sleep quality and vital signs of palliative care patients.
This study will be conducted in a randomized, controlled and experimental manner with patients with hematological malignancies admitted to the Adult Bone Marrow Transplant unit and Hematology-Oncology unit of Acıbadem Altunizade Hospital after obtaining the necessary permissions. The number of patients to be included in the study will be determined by power analysis. The study will include patients who are willing to participate, have no communication problems, are 18 years of age or older, and have no known allergy to lavender oil. Patients with allergies, drug addiction and refusal to participate in the study will not be included in the study. Before the study, patients will be divided into intervention and control groups using a simple random number table. At the beginning of the study, a form including socio-demographic and disease information, Richard Campbell Sleep Quality Scale and Piper Fatigue Scale will be evaluated. Two different options will be used to prevent findings. The first group will be treated with lavender oil and the second group will be treated with saline and 2 drops will be placed on the patient's shoulder 20 minutes before bedtime every night. The application will be started simultaneously with the chemotherapy and will continue until the end of chemotherapy treatment. Sleep and fatigue will be assessed daily using the Richard Campbell Sleep Quality Scale and Piper Fatigue Scale.
Statistical Package for Social Science (SPSS) statistical package program will be used in the evaluation of the data, the conformity of the data to normal distribution will be questioned with Kollmogorov Smirnov test, mean, standard deviation, correlation values will be examined and T-Test will be used to evaluate the relationship between independent groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: Lavander oil Aromatherapyaromatherapy will be performed by dropping 2 drops of lavender oil on the shoulder with a sponge 20 minutes before bedtime every night for a week |
| Control | Sham comparator | Other: Saline SolutionSaline solution will be performed by dropping 2 drops of saline solution on the shoulder with a sponge 20 minutes before bedtime every night for a week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Accepting to participate in the study and being 18 years of age or older
- Cooperation, no communication problems
- Systolic blood pressure above 100 mmHg (lavender can cause hypotension)
- Staying in the bone marrow transplant service for at least two days
Key exclusion criteria (4 listed)
- Known diagnosis of a psychiatric illness (anxiety, panic attacks, depression), a known history of allergy and use of anxiolytic drugs.
- Having arrhythmia
- Do not use sleeping pills
- Allergy to any essential oil
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 |
|---|---|---|
| Lavander oil AromatherapyLavander oil Aromatherapy | Other | Experiment |
| Saline SolutionSaline solution application | Other | Control |
Primary outcome
Descriptive information form
Time frame: 1. day.
The form includes demographic data such as age, gender and education level
Richards Campbell Sleep Quality Scale (RCSQ)
Time frame: 1. day
The sleep quality of the patients was evaluated three times with the Richards Campbell Sleep Quality Scale: preintervention, postintervention day 1 and postintervention day 2. The Richards Campbell Sleep Quality Scale consists of six items evaluating the depth of the patients' night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level in the environment. Each item is evaluated by the patient by questioning the patient's night sleep on a visual analog scale of 0-100. The total score of the scale is obtained from the sum of the five items. The 6th item evaluating the ambient noise level is excluded from the total score evaluation. A score between "0-25" indicates that the quality of the patient's night sleep is very poor and a score between "76-100" indicates that the quality of the patient's night sleep is very good.
Richards Campbell Sleep Quality Scale (RCSQ)
Time frame: 7. day
The sleep quality of the patients was evaluated three times with the Richards Campbell Sleep Quality Scale: preintervention, postintervention day 1 and postintervention day 2. The Richards Campbell Sleep Quality Scale consists of six items evaluating the depth of the patients' night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep and the noise level in the environment. Each item is evaluated by the patient by questioning the patient's night sleep on a visual analog scale of 0-100. The total score of the scale is obtained from the sum of the five items. The 6th item evaluating the ambient noise level is excluded from the total score evaluation. A score between "0-25" indicates that the quality of the patient's night sleep is very poor and a score between "76-100" indicates that the quality of the patient's night sleep is very good.
Piper Fatigue Scale
Time frame: 1. day
The scale developed by Piper B. F. et al. in 1998 consists of a total of 22 items and evaluates the patient's subjective perception of fatigue with four sub-dimensions. These are the behavior/severity sub-dimension (6 items; 2-7), which evaluates the impact and severity of fatigue on activities of daily living (ADL); the affect sub-dimension (5 items; 8-12), which covers the emotional meaning attributed to fatigue; the sensory sub-dimension (5 items; 13-17), which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/mental sub-dimension (6 items; 18-23), which reflects the level of fatigue affecting cognitive functions and mental state. In addition, there are 5 items (1 and 24-27).
Piper Fatigue Scale
Time frame: 7. day
The scale developed by Piper B. F. et al. in 1998 consists of a total of 22 items and evaluates the patient's subjective perception of fatigue with four sub-dimensions. These are the behavior/severity sub-dimension (6 items; 2-7), which evaluates the impact and severity of fatigue on activities of daily living (ADL); the affect sub-dimension (5 items; 8-12), which covers the emotional meaning attributed to fatigue; the sensory sub-dimension (5 items; 13-17), which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/mental sub-dimension (6 items; 18-23), which reflects the level of fatigue affecting cognitive functions and mental state. In addition, there are 5 items (1 and 24-27).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 39775962Yildirim D, Harman Ozdogan M, Erdal S, Selcuk S, Guneri A, Simsek EB, Can TB, Gunduz H, Kuni A. The efficacy of lavender oil on fatigue and sleep quality in patients with hematological malignancy receiving chemotherapy: a single-blind randomized controlled trial. Support Care Cancer. 2025 Jan 8;33(2):79. doi: 10.1007/s00520-024-09143-5.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavander oil Aromatherapy and Saline Solution in people with Hematologic Malignancies and Patient Participation, run by Istanbul Aydın 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 4 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: status not confirmed, as of the sponsor's last update on 11 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive information form (time frame: 1. day.). The study lists 5 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 NCT05808296, 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 11 Apr 2023.