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The Effect of Lavender Oil on Fatigue and Sleep Quality

Primary Purpose

Hematologic Malignancies, Patient Participation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Lavander oil Aromatherapy
Saline Solution
Sponsored by
Istanbul Aydın University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Malignancies focused on measuring Sleep Disorders, Aroma Therapy, Hematologic Malignancies, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dilek YildirimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experiment

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Descriptive information form
The form includes demographic data such as age, gender and education level
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.
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.
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).
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).

Secondary Outcome Measures

Full Information

First Posted
March 30, 2023
Last Updated
March 30, 2023
Sponsor
Istanbul Aydın University
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1. Study Identification

Unique Protocol Identification Number
NCT05808296
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Aydın University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies, Patient Participation
Keywords
Sleep Disorders, Aroma Therapy, Hematologic Malignancies, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Lavander oil Aromatherapy
Intervention Description
Lavander oil Aromatherapy
Intervention Type
Other
Intervention Name(s)
Saline Solution
Intervention Description
Saline solution application
Primary Outcome Measure Information:
Title
Descriptive information form
Description
The form includes demographic data such as age, gender and education level
Time Frame
1. day.
Title
Richards Campbell Sleep Quality Scale (RCSQ)
Description
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.
Time Frame
1. day
Title
Richards Campbell Sleep Quality Scale (RCSQ)
Description
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.
Time Frame
7. day
Title
Piper Fatigue Scale
Description
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).
Time Frame
1. day
Title
Piper Fatigue Scale
Description
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).
Time Frame
7. day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Dilek Yildirim
City
Istanbul
State/Province
Küçükçekmece
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DİLEK YILDIRIM, PHD
Phone
444 1 428
Ext
20114
Email
dilekaticiyildirim@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Lavender Oil on Fatigue and Sleep Quality

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