Effects of Orange Oil Aromatherapy on the Pain and Anxiety

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Effects of Orange Oil Aromatherapy on the Pain and Anxiety During Invasive Interventions in Patients With Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Hematopoietic Transplantation, Bone Marrow Transplantation

Intervention / Treatment
-----------------
* Other: Orange oil aromatherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 | Other: Orange oil aromatherapy<br>* 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.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | 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 | 5 minutes before the aromatherapy | 
| The State-Trait Anxiety Inventory (STAI) | 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 | 5 minutes before the aromatherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematopoietic stem cell transplantation, aromatherapy, pain, anxiety