Tokyo, Sept. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062783) titled 'The Effectiveness of Aromatherapy Massage in Chronic Pain Relief for Parkinson's Disease Patients: A Randomized Controlled Trial' on Sept. 3.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - St.Luke's International University
Condition:
Condition - Parkinson's Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Aromatherapy massage
Interventions/Control_2 - Usual care
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 Size - 28
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065252
Disclaimer: Curated by HT Syndication.