Effect of Orange Aroma on Nausea, Vomiting and Anxiety During Autologous Stem Cell Transplantation

Inhalation Aromatherapy on Nausea, Vomiting and Anxiety During Autologous Hematopoietic Stem Cell Transplantation: An Open-label Randmized Controlled Trial

Patients undergoing stem cell transplantation for the first time will be entered. Participants will be randomized to one of two study arms: Arm 1: intervention (routine care+ inhalation aromatherapy); Arm 2: Control (Routine care) Hypotheses: (1) Patients receiving inhalation aromatherapy will experience less severe nausea and less frequent vomiting episodes than those receiving only routine care; and (2) patients receiving inhalation aromatherapy will demonstrate lower anxiety levels just after AHSCT than those receiving only routine care.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting; Anxiety State
• Intervention / Treatment: Other: Inhalation aromatherapy with orange essential oil

Detailed Description

Earlier research indicates that aromatherapy is promising to relieve in DMSO related nausea and anxiety in autologous stem cell transplant patients. The current study seeks to confirm and extend these findings in a 2-arm, open-label randomized, controlled study of 70 cancer patients undergoing autologous stem cell transplantation. All patients will receive a standardized premedication. Arm 1: Intervention (inhalation aromatherapy with orange essential oil during stem cell infusion); Arm 2: Control (routine care). The researchers hypothesize that inhalation aromatherapy with orange essential oil will be effective in reducing DMSO related nausea and vomiting and demonstrate lower anxiety levels just after autologous stem cell transplantation.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age > 18 years,
• the absence of any mental conditions including depression, anxiety disorders, psychotic disorders or dementia that may affect the patients' communication abilities

Exclusion Criteria:

• Patients with chronic obstructive pulmonary disease or asthma,
• a history of allergy to orange or orange essential oil,
• presence of persistent nausea and vomiting due to conditioning regimens,
• receiving antiemetic other than routine premedication,
• patients undergoing AHSCT for the second or more time were excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervention group; inhalation aromatherapy with orange essential oil	Other: Inhalation aromatherapy with orange essential oil
NO_INTERVENTION: control group; routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nausea severity	Patient report Nausea severity will be assessed based on patient report by using a visual analog scale. The patients will be asked to rate their nausea severity and place a mark on the scale from 0 to 10.	At 1st minute of each stem cell infusion bag
change in number of vomiting	Observation Number of vomiting and retching episodes will be observed by the researcher who apply aromatherapy and recorded in a vomiting and retching episodes form.	From 1st minute of the stem cell infusion to completion of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety	Patient report State Anxiety Inventory will be used to measure anxiety level.	Through stem cell infusion completion, an avarege of 30 minutes

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2015
• Primary Completion (ACTUAL): January 13, 2017
• Study Completion (ACTUAL): January 13, 2017

Study Registration Dates

• First Submitted: February 22, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (ACTUAL): February 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: randomized controlled trial; nausea; anxiety; hematopoietic stem cell transplantation; inhalation aromatherapy
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Nausea; Vomiting; Anxiety Disorders
• Other Study ID Numbers: 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No