UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043490 |
|---|---|
| Receipt number | R000042893 |
| Scientific Title | Study on clinical application of aromatherapy for patients with fibromyalgia |
| Date of disclosure of the study information | 2021/03/03 |
| Last modified on | 2021/03/02 09:28:57 |
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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
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
ryu.masu@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Shioya Hospital
Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042893
