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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04287595
Enrollment
70
Registered
2020-02-27
Start date
2015-03-28
Completion date
2017-01-13
Last updated
2020-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State, Nausea, Vomiting

Keywords

anxiety, hematopoietic stem cell transplantation, inhalation aromatherapy, nausea, randomized controlled trial

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.

Interventions

OTHERInhalation aromatherapy with orange essential oil

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in nausea severityAt 1st minute of each stem cell infusion bagPatient 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 vomitingFrom 1st minute of the stem cell infusion to completion of the interventionObservation 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

MeasureTime frameDescription
anxietyThrough stem cell infusion completion, an avarege of 30 minutesPatient report State Anxiety Inventory will be used to measure anxiety level.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026