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NCT Number: NCT05302583

Aromatherapy Inhaler Use for HSCT Distress

This randomized controlled trial will evaluate the feasibility and acceptability of an inhaled aromatherapy stick for patients during the acute inpatient phase after hematopoietic cell transplantation (HCT) . The study will also explore whether aromatherapy use is associated with short-term changes in patient-reported cancer-related distress and coping self-efficacy.

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Key information

Conditions

Cancer Distress Aromatherapy Cancer Coping Hematopoetic Stem Cell Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Anna Oh, PhD, MPH, RN

CONTACT

[email protected]

650-512-6691

Anna Oh, PhD, MPH, RN

PRINCIPAL_INVESTIGATOR

About this study

Patients undergoing hematopoietic cell transplantation (HCT) commonly experience high levels of distress and other symptoms during the acute inpatient period. Inhaled aromatherapy is a low-burden, patient-directed supportive care strategy that may be feasible to deliver during hospitalization. This randomized, parallel-group study will evaluate the feasibility and acceptability of an aromatherapy inhaler ("aromatherapy stick") during the early post-transplant inpatient period and will explore short-term changes in patient-reported outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Autologous and Allogeneic patients admitted to E1 for planned HSCT
  • Patients with hematologic malignancies requiring HSCT
  • No allergies to lavender or peppermint essential oils
  • Must have received chemotherapy during preparative regimen (single or multi-agent regimen)
  • Adult patient over 18 years of age
  • Able to speak, read, and comprehend English
  • Willing and capable of providing informed consent

Exclusion criteria

  • Patients admitted for Chimeric Antigen Receptor T cell (CART) infusion
  • Patients receiving a transplant for a germ cell tumor diagnosis
  • Unexpected/unplanned admission (e.g., neutropenic fever, confusion, clinical deterioration)
  • Immune effector cell-associated neurotoxicity syndrome (ICANS) grade 1 through 4
  • History of scleroderma
  • History of atrial fibrillation
  • Known history of G6PD deficiency
  • Allergic to lavender or peppermint essential oils
  • Pediatric patient 18 years of age or less
  • Unable to speak, read, and comprehend English
  • Unwilling or incapable of providing informed consent

Treatment and study plan

Aromatherapy Stick

Other

Participants receive aromatherapy inhaler education and an aromatherapy stick for self-administered inhalation during the early post-transplant inpatient period. Aromatherapy use occurs on the assigned Inhaler Use Day (targeted for Transplant Day +1, +2, or +3) and is documented using an inhaler use log. Total exposure is limited to a maximum of 2 hours.

Standard of care

Other

Participants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided.

Primary outcomes

  1. Change in cancer distress (NCCN Distress Thermometer)

    Time frame: Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)

    Change in NCCN Distress Thermometer score (0-10 visual analog scale). Calculated as follow-up score minus baseline score.

Secondary outcomes

  1. Change in cancer coping self-efficacy (Cancer Behavior Inventory-Brief Form, modified)

    Time frame: Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)

    Change in Cancer Behavior Inventory (Brief Form; modified) total score (Likert-type confidence ratings). Calculated as follow-up score minus baseline score.

  2. Aromatherapy Inhaler Use Log (Inhaler Use Log)

    Time frame: 1 day (Inhaler Use Day)

    Number of aromatherapy inhalations recorded by participants on a paper log during the Inhaler Use Day.

  3. Aromatherapy experience (Final Evaluation of Aromatherapy)

    Time frame: Study Completion Day (Transplant Day +4, +5, or +6)

    Participant-rated aromatherapy experience using a 5-item Likert-type scale (1 = Terrible, 5 = Neutral, 10 = Exceptional). (Group B only.)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Oh, PhD, MPH, RN

CONTACT

[email protected]

650-512-6691

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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