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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
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 22, 2020
    Last Updated
    February 25, 2020
    Sponsor
    Hacettepe University
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    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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