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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-28

Study Completion Date

2017-01-13

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.

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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.

Conditions

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Nausea Vomiting Anxiety State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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intervention group

inhalation aromatherapy with orange essential oil

Group Type EXPERIMENTAL

Inhalation aromatherapy with orange essential oil

Intervention Type OTHER

control group

routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Inhalation aromatherapy with orange essential oil

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No