Clinical trial NCT04549857: Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis
Official title: The Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: aromatherapy
rheumatoid arthritis
pain
sleep quality
psychological distress
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Pain Numerical Rating Scale scores
timeFrame: 1 week, 2 weeks and 3 weeks
measure: Changes in Pittsburgh Sleep Quality Index scores
timeFrame: 1 week, 2 weeks and 3 weeks
Secondary outcomes:
measure: Changes in Hospital Anxiety and Depression Scale scores
timeFrame: 1 week, 2 weeks and 3 weeks
measure: Changes in Epworth Sleepiness Scale scores
timeFrame: 1 week, 2 weeks and 3 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
References: