UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062783 |
|---|---|
| Receipt number | R000065252 |
| Scientific Title | The Effectiveness of Aromatherapy Massage in Chronic Pain Relief for Parkinson's Disease Patients: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/09/03 |
| Last modified on | 2026/09/03 10:26:29 |
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Basic information
Public title
The Effectiveness of Aromatherapy Massage in Chronic Pain Relief for Parkinson's Disease Patients: A Randomized Controlled Trial
Acronym
The Effectiveness of Aromatherapy Massage in Chronic Pain Relief for Parkinson's Disease Patients: A Randomized Controlled Trial
Scientific Title
The Effectiveness of Aromatherapy Massage in Chronic Pain Relief for Parkinson's Disease Patients: A Randomized Controlled Trial
Scientific Title:Acronym
The Effectiveness of Aromatherapy Massage in Chronic Pain Relief for Parkinson's Disease Patients: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of aromatherapy massage using essential oils on chronic pain and quality of life in patients with Parkinson's disease . This will be done through a randomized controlled trial comparing a group receiving aromatherapy massage to a group receiving usual care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the Visual Analogue Scale (VAS) score from baseline to 3 weeks after the intervention.
Key secondary outcomes
Change in Conditioned Pain Modulation (CPM) from baseline to 3 weeks after the intervention.
Change in the King's Parkinson's Disease Pain Scale score(KPPS) from baseline to 3 weeks after the intervention.
Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) score from baseline to 3 weeks after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Aromatherapy massage
Interventions/Control_2
Usual care
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Individuals diagnosed with Parkinson's Disease, regardless of gender.
2)No changes or additions to Parkinson's disease medication or deep brain stimulation within the past 4 weeks.
3)A Mini-Mental State Examination (MMSE) score of 18 or higher.
4)Aged 20 years or older.
5)A total score of 1 or higher on the Karnofsky Performance Status Scale (KPPS).
6)Individuals who have provided written informed consent to participate in the study.
Key exclusion criteria
1.Individuals with a history of severe allergic reactions to essential oils or carrier oils (jojoba oil)
2.Individuals who are prone to skin disorders
3.Individuals who are unable to perform aromatherapy massage on their own painful areas
4.Individuals who are scheduled to undergo surgery during the study period
5.Individuals who are unable to understand the study procedures
6.Individuals whose activities of daily living are significantly restricted due to wearing-off
7.Women who are pregnant or may be pregnant
8.Individuals whom the principal investigator considers inappropriate for participation in the study..
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Aoyama |
Organization
St.Luke's International University
Division name
Neuroscience Nursing
Zip code
1040044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
0335436391
hospitarity.aroma@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Aoyama |
Organization
St.Luke's International University
Division name
Neuroscience Nursing
Zip code
104-0044
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
TEL
03-3543-6391
Homepage URL
hospitarity.aroma@tokai.ac.jp
Sponsor or person
Institute
St.Luke's International University
Institute
Department
Personal name
Funding Source
Organization
notheing
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
St. Luke's International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
0335436391
hospitarity.aroma@tokai.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 | 09 | 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
28
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | 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 | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065252
