- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05391347
Effects of Orange Oil Aromatherapy on the Pain and Anxiety
Effects of Orange Oil Aromatherapy on the Pain and Anxiety During Invasive Interventions in Patients With Hematopoietic Stem Cell Transplantation
Study Overview
Status
Intervention / Treatment
Detailed Description
Introduction: Invasive interventions such as peripheral intravenous cannula and port needle placement, and blood collection are often required for both inpatient and outpatient follow-up patients with hematological malignancies and hematopoietic stem cell transplantation patients. This long and difficult treatment process causes anxiety and emotional disorders in most patients. Although invasive initiatives in the treatment and monitoring process are widely implemented, they lead to pain, anxiety and discomfort, which is often ignored. This study conducted to assess the effect of orange oil inhalation used in aromatherapy on pain and anxiety levels in invasive interventions to treat patients with hematological malignancies and hematopoietic stem cells transplantation.
Methods: This randomized controlled experimental study was conducted prospectively with 80 patients with hematological malignancies were treated in the adult bone marrow transplant unit and adult hematology service of a private hospital between May 2021 and January 2022. Orange oil inhalation used in aromatherapy was applied to patients in the intervention group. Visual Analogue Scale and the State-Trait Anxiety Inventory used for data collection.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul Aydin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients older than 18 years old,
- without communication problems,
- without allergy and respiratory system problems,
- who agreed to participate in the study
Exclusion Criteria:
- severe hypotension
- other allergic complications that made it difficult for patients to continue the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
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Experimental: Intervention
3 ml of orange oil were dripping onto the sponge, and the patient was told to breathe slowly at a distance of 3 cm and to smell during the process
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5 minutes before the invasive procedure, 3 ml of orange oil were dripping onto the sponge, and the patient was told to breathe slowly at a distance of 3 cm and to smell during the process.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analog Scale (VAS)
Time Frame: 5 minutes before the aromatherapy
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Visual Analog Scale; A scale applied on a straight line by marking a millimeter horizontal or vertical line.
In this line, the 0 cm dot means "No Pain", while the 10 cm dot means "very bad pain".
The patient marks the pain level on the scale.
The marked point is measured using a tape measure and scored.
Most studies so far show that visual analogue scale (VAS) is a reliable tool to use to assess the pain level
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5 minutes before the aromatherapy
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The State-Trait Anxiety Inventory (STAI)
Time Frame: 5 minutes before the aromatherapy
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In scale; there are 20 questions in the state area.
It provides a four-point Likert type measurement.
Scoring varies between 20-80.
Although there is not a clear cut-off point, 39-40 points are often considered as the cut-off point of inventory.
High score indicates high level of anxiety
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5 minutes before the aromatherapy
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Orange oil aromatherapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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