NCT05251337

Use of Aromatherapy to Reduce Symptom Burden

Completed Phase 2 Results posted Last updated 16 May 2024

What this trial tests

Phase 2 trial testing Essential oils in Anxiety in 92 participants. Completed in 22 June 2023.

Timeline

7 March 2022

Primary endpoint
22 June 2023

22 June 2023

Quick facts

Lead sponsor	Indiana University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	92
Start date	7 March 2022
Primary completion	22 June 2023
Estimated completion	22 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Essential oils — full drug profile →
• Placebo

Conditions studied

• Anxiety — all drugs for Anxiety →
• Chemotherapy-induced Nausea and Vomiting — all drugs for Chemotherapy-induced Nausea and Vomiting →

Sponsor

Indiana University

Who can join

Adults 18 to 100, any sex, with Anxiety or Chemotherapy-induced Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours Primary · baseline (0 hours) and post-intervention (24, 48 hours)

CINVR involves three gastrointestinal symptoms (nausea, vomiting, retching) influenced by administration of chemotherapy. Nausea is expressed as an unpleasant feeling in the throat/epigastrium that can result in expulsion of stomach content, known as vomiting. Retching is the effort to expel stomach contents without success. The Rhodes Index of Nausea, Vomiting and Retching (INVR) was used to measure CINVR and includes 8 Likert-type items on a 5-point scale. Items are scored from 0 (least amount of distress) to 4 (the most distress) and added after reverse coding items 1,3,6, and 7 to calculat

Baseline

Group	Value	95% CI
Intervention - Nausea/Vomiting	9.6	± 4.6
Control - Nausea/Vomiting	8.5	± 4.4

24 hours

Group	Value	95% CI
Intervention - Nausea/Vomiting	5.2	± 3.1
Control - Nausea/Vomiting	4.9	± 3.5

48 hours

Group	Value	95% CI
Intervention - Nausea/Vomiting	3.9	± 3.5
Control - Nausea/Vomiting	4.4	± 4.4

Anxiety Symptoms at Baseline 24 Hours, and 48 Hours Primary · baseline (0 hours) and post-intervention (24, 48 hours)

Anxiety is defined as excessive or persistent worry about aspects of life. Anxiety was measured using a shortened version of Spielberger's State Anxiety Inventory (SAI). The original SAI contains 20 items to measure state anxiety and items are scored using a 4-point Likert-type scale (almost never-almost always). The shortened SAI retains 6 items (from the original 20) and has evidence supporting good internal reliability consistency and strong construct validity. Items are scored from 1 (not at all) to 4 (very much so) and added after reverse coding anxiety absent items, with higher total sco

Baseline

Group	Value	95% CI
Intervention - Anxiety	14.4	± 3.7
Control - Anxiety	15.4	± 4.1

24 hours

Group	Value	95% CI
Intervention - Anxiety	10.9	± 3.3
Control - Anxiety	13.3	± 3.5

48 hours

Group	Value	95% CI
Intervention - Anxiety	10.5	± 3.4
Control - Anxiety	12.9	± 4.1

Patient Satisfaction at 48 Hours Secondary · post-intervention (48 hours)

An investigator-developed questionnaire was administered at the 48-hour study completion to evaluate patient satisfaction. Participants rated their satisfaction with the intervention on a 1-10 rating scale, with 10 being extremely satisfied (e.g., higher score means higher satisfaction).

Rating = 1

Group	Value	95% CI
Intervention - Nausea/Vomiting	0
Intervention - Anxiety	0
Control - Nausea/Vomiting	0
Control - Anxiety	0

Rating = 2

Group	Value	95% CI
Intervention - Nausea/Vomiting	0
Intervention - Anxiety	0
Control - Nausea/Vomiting	1
Control - Anxiety	0

Rating = 3

Group	Value	95% CI
Intervention - Nausea/Vomiting	0
Intervention - Anxiety	0
Control - Nausea/Vomiting	2
Control - Anxiety	0

Rating = 4

Group	Value	95% CI
Intervention - Nausea/Vomiting	0
Intervention - Anxiety	0
Control - Nausea/Vomiting	1
Control - Anxiety	0

Rating = 5

Group	Value	95% CI
Intervention - Nausea/Vomiting	0
Intervention - Anxiety	2
Control - Nausea/Vomiting	2
Control - Anxiety	1

Rating = 6

Group	Value	95% CI
Intervention - Nausea/Vomiting	1
Intervention - Anxiety	1
Control - Nausea/Vomiting	3
Control - Anxiety	5

Rating = 7

Group	Value	95% CI
Intervention - Nausea/Vomiting	2
Intervention - Anxiety	0
Control - Nausea/Vomiting	3
Control - Anxiety	0

Rating = 8

Group	Value	95% CI
Intervention - Nausea/Vomiting	5
Intervention - Anxiety	3
Control - Nausea/Vomiting	5
Control - Anxiety	2

Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe Secondary · 48 hour intervention timeframe

Medications administered for nausea/vomiting indication (scopolamine, lorazepam, promethazine, prochlorperazine, olanzapine, dexamethasone, Marinol, ondansetron). Medications administered for nausea/vomiting symptom indication were extracted from the electronic medical record for participants in the nausea/vomiting symptom group.

Group	Value	95% CI
Intervention - Nausea/Vomiting	10.0	± 5.0
Control - Nausea/Vomiting	7.1	± 5.3

Inpatient Fall Events at Baseline and During Intervention Secondary · baseline (December 2020-February 2022) and during intervention (March 2022-June 2023)

Fall numbers using total number of falls reported to the National Database of Nurse Quality Indicators. Data were extracted from the bone marrow transplant and hematology/oncology units for baseline (December 2020-March 2022) and intervention (March 2022-June 2023) timeframes.

Baseline

Group	Value	95% CI
Participating Units	32

Post

Group	Value	95% CI
Participating Units	31

Adverse events — posted to ClinicalTrials.gov

Time frame: Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention - Nausea/Vomiting

Serious: 0/24 (0%)

Deaths: 0/24

Intervention - Anxiety

Serious: 1/21 (5%)

Deaths: 0/21

Serious adverse events (2 terms)

Reaction	System	Intervention - Nausea/Vomi…	Intervention - Anxiety
Sepsis	Infections and infestations	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Intervention - Nausea/Vomi…	Intervention - Anxiety
Mucositis	Infections and infestations	—	—
Fatigue	General disorders	—	—
Pancytopenia	Immune system disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Neutropenic Fever	Immune system disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Dysuria	Renal and urinary disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Orthostasis	General disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Abdominal Cramps	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—

Most-reported serious reactions: Sepsis, Respiratory failure.

Data from ClinicalTrials.gov NCT05251337 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the effect of inhaled aromatherapy on symptoms of nausea/vomiting and anxiety in patients who have received a stem cell transplant. Aromatherapy involves essential oils from aromatic plants that can be absorbed into the body in different ways. Our study will be using inhaled aromatherapy, which has been found helpful for symptoms such as nausea/vomiting and anxiety.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
   Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418
2. A Randomized Controlled Trial of Aromatherapy to Reduce Symptom Burden in Patients Undergoing Hematopoietic Stem Cell Transplantation.
   Bates M, Thullen A, Basham L, Carter A, et al · · 2024 · cited 1× · PMID 39933106 · DOI 10.1188/25.onf.e1-e11