Effect of Orange Aroma on Nausea, Vomiting and Anxiety During Autologous Stem Cell Transplantation
Primary Purpose
Nausea, Vomiting, Anxiety State
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inhalation aromatherapy with orange essential oil
Sponsored by
About this trial
This is an interventional supportive care trial for Nausea focused on measuring anxiety, hematopoietic stem cell transplantation, inhalation aromatherapy, nausea, randomized controlled trial
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
inhalation aromatherapy with orange essential oil
routine care
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
anxiety
Patient report State Anxiety Inventory will be used to measure anxiety level.
Full Information
NCT ID
NCT04287595
First Posted
February 22, 2020
Last Updated
February 25, 2020
Sponsor
Hacettepe University
1. Study Identification
Unique Protocol Identification Number
NCT04287595
Brief Title
Effect of Orange Aroma on Nausea, Vomiting and Anxiety During Autologous Stem Cell Transplantation
Official Title
Inhalation Aromatherapy on Nausea, Vomiting and Anxiety During Autologous Hematopoietic Stem Cell Transplantation: An Open-label Randmized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2015 (Actual)
Primary Completion Date
January 13, 2017 (Actual)
Study Completion Date
January 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Anxiety State
Keywords
anxiety, hematopoietic stem cell transplantation, inhalation aromatherapy, nausea, randomized controlled trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
inhalation aromatherapy with orange essential oil
Arm Title
control group
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Other
Intervention Name(s)
Inhalation aromatherapy with orange essential oil
Primary Outcome Measure Information:
Title
Change in nausea severity
Description
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.
Time Frame
At 1st minute of each stem cell infusion bag
Title
change in number of vomiting
Description
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.
Time Frame
From 1st minute of the stem cell infusion to completion of the intervention
Secondary Outcome Measure Information:
Title
anxiety
Description
Patient report State Anxiety Inventory will be used to measure anxiety level.
Time Frame
Through stem cell infusion completion, an avarege of 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nur Izgu, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Orange Aroma on Nausea, Vomiting and Anxiety During Autologous Stem Cell Transplantation
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