Acute LeukemiaNCT02445378
Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy
A study testing Aromatherapy and Essential Oils and Questionnaire Administration in people with Acute Leukemia and Anorexia, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized clinical trial studies aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and essential oils may help improve insomnia and other complications caused by chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Leukemia, Anorexia, Anxiety
- What is being tested?
- Aromatherapy and Essential Oils and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2014to 5 Nov 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are newly diagnosed with acute leukemia and hospitalized to receive their initial 4 weeks of intensive induction chemotherapy for this disease
Who cannot join
- Asthma or other reactive airway disease
- Sleep apnea
- Planned less than two week hospitalization
- Change in pain medications/sleeping medications/anxiety medications/antiemetics during the trial
- Patients who have not completed their initial steroids
- Patients who are confused and unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: The Effect of Aromatherapy on Insomnia and Other Common Cancer Patient Symptoms
This randomized clinical trial studies aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and essential oils may help improve insomnia and other complications caused by chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Does the addition of aromatherapy by diffusion of essential oils improve insomnia in newly diagnosed, hospitalized leukemia patients?
SECONDARY OBJECTIVES:
- Does the addition of aromatherapy by diffusion of essential oils improve other common symptoms in newly diagnosed, hospitalized leukemia patients, including pain, nausea, lack of appetite, shortness of breath, depression, anxiety and wellbeing? II. Do newly diagnosed, hospitalized leukemia patients find the use of aromatherapy for symptom management a positive experience?
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.
GROUP II: Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
- Conditions
- Acute Leukemia, Anorexia, Anxiety, Depression, Dyspnea, Insomnia
- Being tested
- Aromatherapy and Essential Oils, Placebo, Questionnaire Administration
- Keywords
- Aromatherapy, essential oils, Acute Leukemia
- Medical subject headings
- Anorexia, Anxiety Disorders, Depression, Dyspnea, Sleep Initiation and Maintenance Disorders, Nausea, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy and Essential OilsProcedure or surgery
Also called Aromatherapy
Undergo aromatherapy and essential oils
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Undergo placebo intervention using rose water
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (aromatherapy and essential oils week 1) | Experimental | Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2. Receives: Procedure: Aromatherapy and Essential Oils; Other: Placebo; Other: Questionnaire Administration |
| Group II (aromatherapy and essential oils week 3) | Experimental | Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2. Receives: Procedure: Aromatherapy and Essential Oils; Other: Placebo; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI)
Statistical analysis will be performed using a mixed effects linear regression model. This model is designed to test the effects of interest (i.e., the effect of aromatherapy relative to baseline and to placebo) while accounting for the within-subject correlation arising from the repeated measures design. A 20% positive change in PSQI score will be seen as significant.
Measured: 1 month
Secondary outcomes (2)
Improvement of common symptoms including pain, nausea, lack of appetite, shortness of breath, depression, anxiety, and wellbeing graded by Edmonton Symptom Assessment Scale - revised (ESASr)
Measured: Baseline to 2 weeks
Rate of positive experience with aromatherapy
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study start28 Dec 2014
- Primary completionSep 2016
- Study completion5 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Blackburn, Ohio State University Comprehensive Cancer Center
- Investigators
- Lisa Blackburn, MS,RN,AOCNS, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445378
- Sponsor's protocol ID
- OSU-14182
- Other IDs
- NCI-2015-00549
- Status last verified
- Mar 2019
- First submitted
- 12 May 2015
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on Insomnia and Other Common Cancer Patient Symptoms
- ClinicalTrials.gov ID
- NCT02445378
- Acronym / sponsor ID
- OSU-14182
- Conditions
- Acute Leukemia, Anorexia, Anxiety, Depression, Dyspnea, Insomnia
- Keywords
- Aromatherapy, essential oils, Acute Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 28 Dec 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 5 Nov 2016 (actual)
- First posted
- 15 May 2015 (estimated)
- 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.
This randomized clinical trial studies aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and essential oils may help improve insomnia and other complications caused by chemotherapy.
Detailed description
PRIMARY OBJECTIVES:
- Does the addition of aromatherapy by diffusion of essential oils improve insomnia in newly diagnosed, hospitalized leukemia patients?
SECONDARY OBJECTIVES:
- Does the addition of aromatherapy by diffusion of essential oils improve other common symptoms in newly diagnosed, hospitalized leukemia patients, including pain, nausea, lack of appetite, shortness of breath, depression, anxiety and wellbeing? II. Do newly diagnosed, hospitalized leukemia patients find the use of aromatherapy for symptom management a positive experience?
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.
GROUP II: Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (aromatherapy and essential oils week 1) | Experimental | Procedure: Aromatherapy and Essential Oils, Other: Placebo, Other: Questionnaire AdministrationPatients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2. |
| Group II (aromatherapy and essential oils week 3) | Experimental | Procedure: Aromatherapy and Essential Oils, Other: Placebo, Other: Questionnaire AdministrationPatients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are newly diagnosed with acute leukemia and hospitalized to receive their initial 4 weeks of intensive induction chemotherapy for this disease
Key exclusion criteria (6 listed)
- Asthma or other reactive airway disease
- Sleep apnea
- Planned less than two week hospitalization
- Change in pain medications/sleeping medications/anxiety medications/antiemetics during the trial
- Patients who have not completed their initial steroids
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 |
|---|---|---|
| Aromatherapy and Essential OilsAlso: AromatherapyUndergo aromatherapy and essential oils | Procedure or surgery | Group I (aromatherapy and essential oils week 1), Group II (aromatherapy and essential oils week 3) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyUndergo placebo intervention using rose water | Other | Group I (aromatherapy and essential oils week 1), Group II (aromatherapy and essential oils week 3) |
| Questionnaire AdministrationAncillary studies | Other | Group I (aromatherapy and essential oils week 1), Group II (aromatherapy and essential oils week 3) |
Primary outcome
Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI)
Time frame: 1 month
Statistical analysis will be performed using a mixed effects linear regression model. This model is designed to test the effects of interest (i.e., the effect of aromatherapy relative to baseline and to placebo) while accounting for the within-subject correlation arising from the repeated measures design. A 20% positive change in PSQI score will be seen as significant.
2 secondary outcomes
Improvement of common symptoms including pain, nausea, lack of appetite, shortness of breath, depression, anxiety, and wellbeing graded by Edmonton Symptom Assessment Scale - revised (ESASr)
Time frame: Baseline to 2 weeks
Rate of positive experience with aromatherapy
Time frame: Up to 2 weeks
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 5 Apr 2019.
- The JameslineLink provided by the sponsor.
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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.
Lisa Blackburn, MS,RN,AOCNS principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Essential Oils and Questionnaire Administration in people with Acute Leukemia and Anorexia, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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 1 inclusion and 6 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 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Improvement of Insomnia graded by Pittsburgh Sleep Quality Index (PSQI) (time frame: 1 month). 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 5 Apr 2019.