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

NCT04549857 | Completed

• 1 other identifier: TYGH108056
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

aromatherapy; rheumatoid arthritis; pain; sleep quality; psychological distress

Outcome Measures

Primary Outcomes (2)

• 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

  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

  1 week, 2 weeks and 3 weeks

Secondary Outcomes (2)

• Changes in Hospital Anxiety and Depression Scale scores

  1 week, 2 weeks and 3 weeks

• Changes in Epworth Sleepiness Scale scores

  1 week, 2 weeks and 3 weeks

Study Arms (3)

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.

Behavioral: aromatherapy

Placebo group

PLACEBO COMPARATOR

The placebo group only used base oil (sweet almond oil).

Behavioral: aromatherapy

Control group

NO INTERVENTION

No intervention

Interventions

aromatherapy BEHAVIORAL

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. 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.

Placebo group; intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Pain; Sleep Initiation and Maintenance Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 16, 2020
• Study Start: November 19, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: October 13, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)