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OpenTrials
Completed

NCT Number: NCT04287595

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

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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Key information

Conditions

Nausea Anxiety Disorders Anxiety State Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inhalation aromatherapy with orange essential oil

Other

Primary outcomes

  1. Change in nausea severity

    Time frame: 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.

  2. change in number of vomiting

    Time frame: 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 outcomes

  1. anxiety

    Time frame: Through stem cell infusion completion, an avarege of 30 minutes

    Patient report State Anxiety Inventory will be used to measure anxiety level.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 27, 2020
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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