UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060536 |
|---|---|
| Receipt number | R000069080 |
| Scientific Title | Effects of Aromatherapy on Stress and Pain in Cancer Related Patients A Single Arm Pre Post Intervention Study |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/28 19:54:04 |
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Basic information
Public title
A Study to Examine the Effects of Aromatherapy on Stress and Pain in Patients with Cancer
Acronym
Cancer Aromatherapy Care Study
Scientific Title
Effects of Aromatherapy on Stress and Pain in Cancer Related Patients A Single Arm Pre Post Intervention Study
Scientific Title:Acronym
Aromatherapy Intervention Pre Post Study in Cancer Patients
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of aromatherapy on stress and pain in patients with cancer using pre and post intervention salivary biomarkers and questionnaire based outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary stress related hormones before and after aromatherapy treatment
Key secondary outcomes
Pain assessed by the Visual Analogue Scale (VAS) and mood assessed by the Two Dimensional Mood Scale (TDMS) before and after aromatherapy treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Aromatherapy treatment
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals diagnosed with cancer who are continuing treatment at home, and who are between 40 and 95 years of age at the time of obtaining informed consent.
2. Individuals who voluntarily request to receive aromatherapy treatment.
3. Individuals who are judged by their attending physicians to be eligible for participation in this study.
4. Individuals who are determined by their attending physicians not to require inpatient treatment for the time being.
5. Individuals who have received a sufficient explanation of this study, have understood its content, and have provided written informed consent to participate.
Key exclusion criteria
1. Individuals with allergies to nuts, particularly those with almond allergy.
2. Individuals who are judged by their attending physician to be likely to experience an adverse impact on their medical treatment as a result of participation in this study.
3. Individuals who have been diagnosed by their attending physician as having terminal cancer or being in an end of life condition.
4. Individuals who show a positive reaction to the essential oils used in this study in a patch test conducted prior to aromatherapy treatment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Japanese Red Cross Hokkaido College of Nursing
Division name
Department of Health Sciences
Zip code
090-0011
Address
664-1, Akebono-chou, Kitami, Hokkaido 090-0011, Japan
TEL
+81-(0)157-66-3390
yama@rchokkaido-cn.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Tokorozawa |
Organization
Tori Aroma Therapy Laboratory
Division name
Director
Zip code
240-0107
Address
1-21-24, Shonan Kokusaimura, Yokosuka, Kanagawa 240-0107, Japan
TEL
+81-(0)46-802-8181
Homepage URL
info@aroma-tori.com
Sponsor or person
Institute
Japanese Red Cross Hokkaido College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Shonan University of Medical Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Japanese Red Cross Hokkaido College of Nursing
Address
664-1, Akebono-chou, Kitami, Hokkaido 090-0011, Japan
Tel
+81-(0)157-66-3311
keiri@rchokkaido-cn.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069080
