Rheumatoid ArthritisNCT04549857
Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis
A study testing aromatherapy in people with Rheumatoid Arthritis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study aims to explore the effects of aromatherapy on pain, sleep quality, and psychological distress in patients with rheumatoid arthritis. The following hypotheses are tested: The experimental group received aromatherapy will report significant improvement on pain, sleep quality, and psychological distress.The… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- aromatherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Nov 2020to 10 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis.
This study aims to explore the effects of aromatherapy on pain, sleep quality, and psychological distress in patients with rheumatoid arthritis. The following hypotheses are tested: The experimental group received aromatherapy will report significant improvement on pain, sleep quality, and psychological distress.The comfort group shows no significant differences.
Read the detailed description
The purpose of the research was to explore the effects of aromatherapy on pain, sleep quality, and psychological distress in patients with rheumatoid arthritis. The subjects of the study adopted the intentional sampling method, and the place of collection was patients with rheumatoid arthritis in the outpatient department of the rheumatology and immunology department of the hospital. The study was conducted with a randomized controlled trial design. It is estimated that 159 patients with rheumatoid arthritis will be admitted, and the participants will be randomly allocated into the experimental group, the comfort group and the control group with 53 participants. The experimental group received base oil and essential oil massage, the comfort group only received base oil massage for 10 minutes each time, three times a week for three weeks, and the control group did not receive any intervention measures. Repeated measurements were used to collect data using structured questionnaires. Pain was measured by the Numerical Rating Scale, and sleep quality was measured by the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale. Scale) measurement and psychological distress were measured by the Hospital Anxiety and Depression Scale. Data were collected at four time points before the intervention, the first week, the second week, and the third week after the intervention. The data obtained are processed and analyzed using SPSS version 22.00 computer software. Statistical analysis methods include independent sample single-factor variance analysis to compare the differences in basic data and pain levels between the experimental group, the comfort group and the control group; repeated measurement of single-factor variation Analyze the comparison of intra-group differences among the three groups at four time points; finally, compare the effects of the three groups on pain and sleep quality after aromatherapy interventions using the generalized estimation equation.
- Conditions
- Rheumatoid Arthritis
- Being tested
- aromatherapy
- Keywords
- aromatherapy, rheumatoid arthritis, pain, sleep quality, psychological distress
- Medical subject headings
- Arthritis, Rheumatoid, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapyBehavioural
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.
- 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.
- The placebo group only used base oil (sweet almond oil).
- The control group did not provide any interventional measures and only received conventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Behavioral: aromatherapy |
| Placebo group | Placebo comparator | The placebo group only used base oil (sweet almond oil). Receives: Behavioral: aromatherapy |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Numerical Rating Scale scores
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
Measured: 1 week, 2 weeks and 3 weeks
Changes in Pittsburgh Sleep Quality Index scores
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
Measured: 1 week, 2 weeks and 3 weeks
Secondary outcomes (2)
Changes in Hospital Anxiety and Depression Scale scores
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.
Measured: 1 week, 2 weeks and 3 weeks
Changes in Epworth Sleepiness Scale scores
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.
Measured: 1 week, 2 weeks and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start19 Nov 2020
- Primary completion10 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549857
- Sponsor's protocol ID
- TYGH108056
- Status last verified
- Jul 2021
- First submitted
- 10 Sep 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT04549857
- Acronym / sponsor ID
- TYGH108056
- Conditions
- Rheumatoid Arthritis
- Keywords
- aromatherapy, rheumatoid arthritis, pain, sleep quality, psychological distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore the effects of aromatherapy on pain, sleep quality, and psychological distress in patients with rheumatoid arthritis. The following hypotheses are tested: The experimental group received aromatherapy will report significant improvement on pain, sleep quality, and psychological distress.The comfort group shows no significant differences.
Detailed description
The purpose of the research was to explore the effects of aromatherapy on pain, sleep quality, and psychological distress in patients with rheumatoid arthritis. The subjects of the study adopted the intentional sampling method, and the place of collection was patients with rheumatoid arthritis in the outpatient department of the rheumatology and immunology department of the hospital. The study was conducted with a randomized controlled trial design. It is estimated that 159 patients with rheumatoid arthritis will be admitted, and the participants will be randomly allocated into the experimental group, the comfort group and the control group with 53 participants. The experimental group received base oil and essential oil massage, the comfort group only received base oil massage for 10 minutes each time, three times a week for three weeks, and the control group did not receive any intervention measures. Repeated measurements were used to collect data using structured questionnaires. Pain was measured by the Numerical Rating Scale, and sleep quality was measured by the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale. Scale) measurement and psychological distress were measured by the Hospital Anxiety and Depression Scale. Data were collected at four time points before the intervention, the first week, the second week, and the third week after the intervention. The data obtained are processed and analyzed using SPSS version 22.00 computer software. Statistical analysis methods include independent sample single-factor variance analysis to compare the differences in basic data and pain levels between the experimental group, the comfort group and the control group; repeated measurement of single-factor variation Analyze the comparison of intra-group differences among the three groups at four time points; finally, compare the effects of the three groups on pain and sleep quality after aromatherapy interventions using the generalized estimation equation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: aromatherapyThe 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. |
| Placebo group | Placebo comparator | Behavioral: aromatherapyThe placebo group only used base oil (sweet almond oil). |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromatherapyThe 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. 1. 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. 2. The placebo group only used base oil (sweet almond oil). 3. The control group did not provide any interventional measures and only received conventional treatment. | Behavioural | Placebo group, intervention group |
Primary outcome
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
Changes in Pittsburgh Sleep Quality Index scores
Time frame: 1 week, 2 weeks and 3 weeks
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
2 secondary outcomes
Changes in Hospital Anxiety and Depression Scale scores
Time frame: 1 week, 2 weeks and 3 weeks
Changes in Epworth Sleepiness Scale scores
Time frame: 1 week, 2 weeks and 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aromatherapy in people with Rheumatoid Arthritis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain Numerical Rating Scale scores (time frame: 1 week, 2 weeks and 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.