Effects of Orange Oil Aromatherapy on the Pain and Anxiety

May 20, 2022 updated by: DİLEK YILDIRIM, Istanbul Aydın University

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

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 Overview

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

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Istanbul Aydin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: Control
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 5 minutes before the aromatherapy
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)
Time Frame: 5 minutes before the aromatherapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

January 30, 2022

Study Registration Dates

First Submitted

May 18, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

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)?

NO

IPD Plan Description

The data that support the findings of this study are available from the researchers (i.e. upon rea-sonable request).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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