The Effect of Lavender Oil on Fatigue and Sleep Quality

Trial Title: The Effect of Lavender Oil on Fatigue and Sleep Quality

NCT ID: NCT05808296

Condition: Hematologic Malignancies
Patient Participation

Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Fatigue

Conditions: Keywords:
Sleep Disorders
Aroma Therapy
Hematologic Malignancies
Fatigue

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Lavander oil Aromatherapy
Description: Lavander oil Aromatherapy
Arm group label: Experiment

Intervention type: Other
Intervention name: Saline Solution
Description: Saline solution application
Arm group label: Control

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Dilek Yildirim

Address:
City: Istanbul
Country: Turkey

Status: Recruiting

Contact:
Last name: DİLEK YILDIRIM, PHD

Phone: 444 1 428

Phone ext: 20114
Email: dilekaticiyildirim@gmail.com

Start date: January 1, 2022

Completion date: April 30, 2023

Lead sponsor:
Agency: Istanbul Aydın University
Agency class: Other

Source: Istanbul Aydın University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05808296