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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287595
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: March 28, 2015
• Est. completion date: January 13, 2017

Study information

• Verified date: February 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 13, 2017
• Est. primary completion date: January 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Nausea
• Vomiting

Intervention

Other:
• Inhalation aromatherapy with orange essential oil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	anxiety	Patient report State Anxiety Inventory will be used to measure anxiety level.	Through stem cell infusion completion, an avarege of 30 minutes