NauseaNCT04287595
Effect of Orange Aroma on Nausea, Vomiting and Anxiety During Autologous Stem Cell Transplantation
A study testing Inhalation aromatherapy with orange essential oil in people with Nausea and Vomiting, run by Hacettepe University.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea, Vomiting, Anxiety State
- What is being tested?
- Inhalation aromatherapy with orange essential oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2015to 13 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years,
- the absence of any mental conditions including depression, anxiety disorders, psychotic disorders or dementia that may affect the patients' communication abilities
Who cannot join
- 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
About this study
Official title: Inhalation Aromatherapy on Nausea, Vomiting and Anxiety During Autologous Hematopoietic Stem Cell Transplantation: An Open-label Randmized Controlled Trial
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.
Read the 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.
- Conditions
- Nausea, Vomiting, Anxiety State
- Being tested
- Inhalation aromatherapy with orange essential oil
- Keywords
- anxiety, hematopoietic stem cell transplantation, inhalation aromatherapy, nausea, randomized controlled trial
- Medical subject headings
- Nausea, Vomiting, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhalation aromatherapy with orange essential oilOther
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | inhalation aromatherapy with orange essential oil Receives: Other: Inhalation aromatherapy with orange essential oil |
| control group | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1st minute of each stem cell infusion bag
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.
Measured: From 1st minute of the stem cell infusion to completion of the intervention
Secondary outcomes (1)
anxiety
Patient report State Anxiety Inventory will be used to measure anxiety level.
Measured: Through stem cell infusion completion, an avarege of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start28 Mar 2015
- Primary completion13 Jan 2017
- Study completion13 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Izgu, Hacettepe University
- Investigators
- Nur Izgu, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287595
- Sponsor's protocol ID
- 2
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalation Aromatherapy on Nausea, Vomiting and Anxiety During Autologous Hematopoietic Stem Cell Transplantation: An Open-label Randmized Controlled Trial
- ClinicalTrials.gov ID
- NCT04287595
- Acronym / sponsor ID
- 2
- Conditions
- Nausea, Vomiting, Anxiety State
- Keywords
- anxiety, hematopoietic stem cell transplantation, inhalation aromatherapy, nausea, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Mar 2015 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 13 Jan 2017 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Inhalation aromatherapy with orange essential oilinhalation aromatherapy with orange essential oil |
| control group | No intervention | –routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years,
- the absence of any mental conditions including depression, anxiety disorders, psychotic disorders or dementia that may affect the patients' communication abilities
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhalation aromatherapy with orange essential oil | Other | intervention group |
Primary outcome
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.
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.
1 secondary outcome
anxiety
Time frame: Through stem cell infusion completion, an avarege of 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: No
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Izgu, PhD principal investigator
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation aromatherapy with orange essential oil in people with Nausea and Vomiting, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nausea severity (time frame: At 1st minute of each stem cell infusion bag). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.