The Effect of Lavender Oil on Fatigue and Sleep Quality

NCT ID: NCT05808296

Last Updated: 2023-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Hematologic Malignancies Patient Participation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Lavander oil Aromatherapy

Intervention Type OTHER

Lavander oil Aromatherapy

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

Group Type SHAM_COMPARATOR

Saline Solution

Intervention Type OTHER

Saline solution application

Interventions

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Lavander oil Aromatherapy

Lavander oil Aromatherapy

Intervention Type OTHER

Saline Solution

Saline solution application

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Aydın University

OTHER

Sponsor Role lead

Responsible Party

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DİLEK YILDIRIM

Assistant Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dilek Yildirim

Istanbul, Küçükçekmece, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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DİLEK YILDIRIM, PHD

Role: primary

444 1 428 ext. 20114

References

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Yildirim D, Harman Ozdogan M, Erdal S, Selcuk S, Guneri A, Simsek EB, Can TB, Gunduz H, Kuni A. The efficacy of lavender oil on fatigue and sleep quality in patients with hematological malignancy receiving chemotherapy: a single-blind randomized controlled trial. Support Care Cancer. 2025 Jan 8;33(2):79. doi: 10.1007/s00520-024-09143-5.

Reference Type DERIVED
PMID: 39775962 (View on PubMed)

Other Identifiers

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Lavender Oil on Hematological

Identifier Type: -

Identifier Source: org_study_id

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