Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05808296 |
Other study ID # |
Lavender Oil on Hematological |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2022 |
Est. completion date |
April 30, 2023 |
Study information
Verified date |
March 2023 |
Source |
Istanbul Aydin University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.