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

Not Applicable

Completed

• Conditions: Anxiety State; Nausea; Vomiting
• Interventions: Other: Inhalation aromatherapy with orange essential oil

• Registration Number: NCT04287595
• Lead Sponsor: Hacettepe University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-03-28
• Primary Completion: 2017-01-13
• Study Completion: 2017-01-13
• Status Verified: 2020-02
• Study First Submitted: 2020-02-22
• Study First Submitted QC: 2020-02-25
• Last Update Submitted: 2020-02-25
• Study First Posted: 2020-02-27
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Inhalation aromatherapy with orange essential oil	inhalation aromatherapy with orange essential oil

Primary Outcome Measures

Name	Time	Method
Change in nausea severity	At 1st minute of each stem cell infusion bag	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.
change in number of vomiting	From 1st minute of the stem cell infusion to completion of the intervention	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.

Secondary Outcome Measures

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