UMIN-CTR Clinical Trial

Basic information
Public title	Study on clinical application of aromatherapy for patients with fibromyalgia
Acronym	Study on clinical application of aromatherapy for patients with fibromyalgia
Scientific Title	Study on clinical application of aromatherapy for patients with fibromyalgia
Scientific Title:Acronym	Study on clinical application of aromatherapy for patients with fibromyalgia
Region	Japan

Condition
Condition	fibromyalgia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients with chronic pain, such as fibromyalgia, have adverse effects such as daily emotional instability, depression, and lack of sleep, resulting in lower quality of life. However, there are no drugs available to date that improve patients' quality of life. On the other hand, aromatic phytotherapy (aromatherapy) has long been used in various life situations and has been used to improve the quality of life of healthy individuals. If the usefulness of aromatherapy for fibromyalgia patients is scientifically elucidated, it will lead to the active use of aromatherapy in the medical field. Therefore, in this application, we will study the effects of essential oils for the purpose of acquiring clinical data for scientific elucidation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	At the consultation, the pain clinic doctor measures the numeric rating scale, pain disability assessment scale, EuroQol, and Self-Rating Depression Scale on an outpatient basis.
Key secondary outcomes	Observation and inspection are performed for the following items. Also, we will ask for a response to the questionnaire and use the data for this study. These are activities that go beyond normal practice and are performed for research purposes. 1) Basic patient information: age, gender, medical history, height, weight, etc. 2) Blood test 3) Evaluation items of State trait Anxiety Inventery (STAI), numeric rating scale, Pain disability assessment scale, EuroQol, and Self-Rating Depression Scale measured by the attending physician before and after aromatherapy was performed. 4) Biomarkers in saliva (chromogranin A, cortisol, alpha-amylase) 5) Blood pressure and heart rate 6) Oral medication

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Instruct the patient to be treated daily with oil (excluding geranium essential oil) (3 months), and instruct the patient to treat daily with oil (including geranium essential oil) (3 months)
Interventions/Control_2	Instruct the patient to treat daily with oil (including geranium essential oil) (3 months) and instruct the patient to treat daily with oil (excluding geranium essential oil) (3 months)
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients who visit from June 1, 2019 to June 1, 2020 2. Patients who can obtain written consent from voluntary research participation 3. Patients who are 20 years old or older and younger than 80 years old when obtaining consent 4. Gender: male and female
Key exclusion criteria	1. Women who are pregnant or may be pregnant
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Suda Middle name Last name Yasunori
Organization	International University of Health and Welfare Shioya Hospital
Division name	Anesthesiology
Zip code	329-2145
Address	77 Tomita, Yaita City, Tochigi Prefecture
TEL	0287-44-1155
Email	jariyama@iuhw.ac.jp

Public contact
Name of contact person	1st name Ryuichiro Middle name Last name Masubuchi
Organization	International University of Health and Welfare Shioya Hospital
Division name	Pharmaceutical department
Zip code	329-2145
Address	77 Tomita, Yaita City, Tochigi Prefecture
TEL	0287-44-1155
Homepage URL
Email	ryu.masu@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare Shioya Hospital Anesthesiology
Institute
Department

Funding Source
Organization	International University of Health and Welfare Shioya Hospital Anesthesiology
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	International University of Health and Welfare Hospital
Address	537-3 Iguchi, Nasushiobara City, Tochigi Prefecture
Tel	0287-37-2221
Email	atakaku@iuhw.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	国際医療福祉大学塩谷病院（栃木県）

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 03 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	10
Results	There was no significant difference in blood pressure before and after the treatment in both the control group and the geranium essential oil group. Heart rate after the treatment showed a decreasing trend in the control group and a significant decrease in the geranium essential oil group. The STAI score for assessing pain stress in fibromyalgia patients was not significantly different in the control group and the geranium essential oil group. Translated with www.DeepL.com/Translator (free version)
Results date posted	2021 Year 02 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	After October 2018, patients undergoing outpatient treatment at the pain clinic of the International University of Health and Welfare Hospital who meet the diagnostic criteria for fibromyalgia published by the American College of Rheumatology in 20161) and who do not meet any of the exclusion criteria will be eligible for enrollment.
Participant flow
Adverse events
Outcome measures	1) State trait Anxiety Inventery (STAI) measured by the physician before and after aromatherapy 2) Blood pressure and heart rate
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 11 Month 10 Day
Date of IRB	2019 Year 12 Month 18 Day
Anticipated trial start date	2019 Year 12 Month 18 Day
Last follow-up date	2020 Year 12 Month 10 Day
Date of closure to data entry	2020 Year 12 Month 31 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2021 Year 03 Month 02 Day
Last modified on	2021 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042893