Clinical trial NCT05808296: The Effect of Lavender Oil on Fatigue and Sleep Quality
Official title: The Effect of Lavender Oil on Fatigue and Sleep Quality in Patients With Hematologic Malignancy: A Single Blinding Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Malignancies
Patient Participation
Keywords: Sleep Disorders
Aroma Therapy
Hematologic Malignancies
Fatigue
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Descriptive information form
timeFrame: 1. day.
measure: Richards Campbell Sleep Quality Scale (RCSQ)
timeFrame: 1. day
measure: Richards Campbell Sleep Quality Scale (RCSQ)
timeFrame: 7. day
measure: Piper Fatigue Scale
timeFrame: 1. day
measure: Piper Fatigue Scale
timeFrame: 7. day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dilek Yildirim
state: Küçükçekmece
Study officials:
References: