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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nausea, Vomiting, Anxiety State

Intervention / Treatment
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* Other: Inhalation aromatherapy with orange essential oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>inhalation aromatherapy with orange essential oil | Other: Inhalation aromatherapy with orange essential oil<br> <br> |
| No Intervention: control group<br>routine care | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, hematopoietic stem cell transplantation, inhalation aromatherapy, nausea, randomized controlled trial