- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04549857
Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis
The Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan, 112
- National Yang-Ming University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed by a doctor as rheumatoid arthritis.
- Over 20 years old.
- No history of allergy to essential oils in the past.
- A person with clear consciousness and able to communicate in Mandarin or Taiwanese.
- Those who are willing to participate in this research after the explanation.
- The main part of the pain in the past month is the joints of the hand.
- Have equipment that can watch movies.
Exclusion Criteria:
- There is a history of wounds or surgery around the wrist or finger joints.
- Those who are contraindicated in aromatherapy and those with high risk such as asthma, epilepsy, and pregnant.
- Receive physical therapy or complementary therapy during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
No intervention
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Experimental: intervention group
The experimental group used the base oil (sweet almond oil) to add Atlantic cedar, sweet marjoram and sweet orange essential oils.
The essential oils were blended into 5% massage oil at a ratio of 3:1:1.
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The intervention measures were taught by the researchers to perform self-massage on both wrists and finger joints in the experimental group and the comfort group, using 5ml each time (2.5ml each for one hand), 10 minutes each time (5 minutes for each hand), three times a week, It lasts for three weeks. The massage steps refer to dōTERRA's Aroma Touch Hand Technique. Before self-massage is performed, a professional must first ensure that the execution process is correct and the professional will use the phone to follow up weekly.
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Placebo Comparator: Placebo group
The placebo group only used base oil (sweet almond oil).
|
The intervention measures were taught by the researchers to perform self-massage on both wrists and finger joints in the experimental group and the comfort group, using 5ml each time (2.5ml each for one hand), 10 minutes each time (5 minutes for each hand), three times a week, It lasts for three weeks. The massage steps refer to dōTERRA's Aroma Touch Hand Technique. Before self-massage is performed, a professional must first ensure that the execution process is correct and the professional will use the phone to follow up weekly.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Pain Numerical Rating Scale scores
Time Frame: 1 week, 2 weeks and 3 weeks
|
Change from baseline Pain Numerical Rating Scale scores at 1 week, 2 weeks and 3 weeks.
The total score range is 0-10; a higher score indicates more pain
|
1 week, 2 weeks and 3 weeks
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Changes in Pittsburgh Sleep Quality Index scores
Time Frame: 1 week, 2 weeks and 3 weeks
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Change from baseline Pittsburgh Sleep Quality Index scores at 1 week, 2 weeks and 3 weeks.
The total score range is 0-21; a higher score indicates poor sleep
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1 week, 2 weeks and 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Hospital Anxiety and Depression Scale scores
Time Frame: 1 week, 2 weeks and 3 weeks
|
Change from baseline Hospital Anxiety and Depression Scale scores with two subscales at 1 week, 2 weeks and 3 weeks.
Each subscale score range is 0-21; a higher score indicates higher anxiety and depression.
|
1 week, 2 weeks and 3 weeks
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Changes in Epworth Sleepiness Scale scores
Time Frame: 1 week, 2 weeks and 3 weeks
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Change from baseline Epworth Sleepiness Scale scores at 1 week, 2 weeks and 3 weeks.
The total score range is 0-24; a higher score indicates more sleepiness.
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1 week, 2 weeks and 3 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TYGH108056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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