Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04549857 |
Other study ID # |
TYGH108056 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 19, 2020 |
Est. completion date |
May 10, 2021 |
Study information
Verified date |
July 2021 |
Source |
National Yang Ming University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 comfort group shows no significant
differences.
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.