The Effect of Lavender Oil on Fatigue and Sleep Quality
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
April 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedApril 11, 2023
March 1, 2023
1.3 years
March 30, 2023
March 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Descriptive information form
The form includes demographic data such as age, gender and education level
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.
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.
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).
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).
7. day
Study Arms (2)
Experiment
EXPERIMENTALaromatherapy 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 COMPARATORSaline 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dilek Yildirim
Istanbul, Küçükçekmece, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 39775962DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Prof.
Study Record Dates
First Submitted
March 30, 2023
First Posted
April 11, 2023
Study Start
January 1, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
April 11, 2023
Record last verified: 2023-03