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Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
aromatherapy
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring aromatherapy, rheumatoid arthritis, pain, sleep quality, psychological distress

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

intervention group

Placebo group

Control group

Arm Description

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).

No intervention

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 10, 2020
Last Updated
October 12, 2022
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04549857
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
aromatherapy, rheumatoid arthritis, pain, sleep quality, psychological distress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group only used base oil (sweet almond oil).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
aromatherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Pain Numerical Rating Scale scores
Description
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
Time Frame
1 week, 2 weeks and 3 weeks
Title
Changes in Pittsburgh Sleep Quality Index scores
Description
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
Time Frame
1 week, 2 weeks and 3 weeks
Secondary Outcome Measure Information:
Title
Changes in Hospital Anxiety and Depression Scale scores
Description
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.
Time Frame
1 week, 2 weeks and 3 weeks
Title
Changes in Epworth Sleepiness Scale scores
Description
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.
Time Frame
1 week, 2 weeks and 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Aromatherapy on Pain, Sleep Quality, and Psychological Distress in Patients With Rheumatoid Arthritis

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