The Effect of Lavender Oil on Fatigue and Sleep Quality

Sponsor
Istanbul Aydın University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05808296
Collaborator
(none)
100
1
2
15.9
6.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lavander oil Aromatherapy
  • Other: Saline Solution
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Lavender Oil on Fatigue and Sleep Quality in Patients With Hematologic Malignancy: A Single Blinding Randomized Controlled Study
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experiment

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

Other: Lavander oil Aromatherapy
Lavander oil Aromatherapy

Sham Comparator: Control

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

Other: Saline Solution
Saline solution application

Outcome Measures

Primary Outcome Measures

  1. Descriptive information form [1. day.]

    The form includes demographic data such as age, gender and education level

  2. Richards Campbell Sleep Quality Scale (RCSQ) [1. day]

    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.

  3. Richards Campbell Sleep Quality Scale (RCSQ) [7. day]

    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.

  4. Piper Fatigue Scale [1. day]

    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).

  5. Piper Fatigue Scale [7. day]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dilek Yildirim Istanbul Küçükçekmece Turkey

Sponsors and Collaborators

  • Istanbul Aydın University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DİLEK YILDIRIM, Assistant Prof., Istanbul Aydın University
ClinicalTrials.gov Identifier:
NCT05808296
Other Study ID Numbers:
  • Lavender Oil on Hematological
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 11, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by DİLEK YILDIRIM, Assistant Prof., Istanbul Aydın University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2023