Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Chronic Pain

In recent decades, following an increased longevity in Hong Kong, there is a drastic increase in the prevalence chronic conditions, including chronic pain, seems to be the main reasons of suffering for many older adults. This condition not only pose a burden to the whole family but also the healthcare system.

While conventional treatment of chronic pain using pharmacotherapy and non-pharmacological treatments has been effective for managing symptoms, owing to the adverse side effects caused by anti-psychotic drugs and the short effective period incurred by non-pharmacological interventions, development of alternative and non-pharmacological approaches for the management of pain is of urgent need. Research has shown that aromatherapy (both administered through inhalation and therapeutic massage) has been effective in reducing showing pain-relieving effects. These findings support the premise that aromatherapy and the investigators hope to provide further evidence to support the use of aromatherapy as an evidence-based mainstream intervention for pain relief in older adults with chronic pain.

Whilst there is sufficient evidence to support the effectiveness of aromatherapy, few studies compared the effectiveness of the use of aromatherapy by inhalation and/or therapeutic massage. The investigators aim to address the above research gaps on the clinical application of aromatherapy on chronic pain, with a focus on comparing the differential effectiveness between administration by inhalation and administration by therapeutic massage. The proposed research aims to (1) test the efficacy and effectiveness of aromatherapy on the symptom management of chronic pain in older adults; (2) compare the effects of aromatherapy-scent (i.e., inhalation) and aromatherapy-touch (i.e., therapeutic massage) in older adults with chronic pain. This study also explores the benefits of aromatherapy on cognitive functioning, functional performance and social engagement as secondary outcomes.

A randomized, controlled, and single blinded trial is proposed. 120 older adults with chronic pain will be randomly assigned to aroma inhalation (intervention), aroma-touch or wait-list (control) treatments. Pain intensity and subjective changes in mood states (primary outcome), cognitive functioning, functional performance and social engagement (secondary outcome) will be assessed three times: pre-treatment, mid-treatment, post-treatment. If the study hypotheses are supported, the findings will provide empirical support for a treatment option that could improve manage the symptoms of patients diagnosed with chronic conditions, and also improve cognitive functioning, functional performance, and social engagement of older adults.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: aromatherapy

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 60 years of age or older
• having a CMMSE score over or equal to 15
• having chronic pain or a widespread pain condition such as fibromyalgia for at least 3 months
• be willing to participate in the research, with informed consent signed by their guardian or carer.

Exclusion Criteria:

• being allergic to essential oils
• refusal to give consent
• being over-sensitive to tactile stimulation
• having a history of kidney and liver disease
• no history of an epileptic seizure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aromatherapy-scent	Other: aromatherapy; Each of participants in the aromatherapy (inhalation) group will receive inhalation aromatherapy and those in the aromatherapy (massage) group will receive aromatherapeutic massage. As to the waiting control group, participants will be given either one of these two interventions after the implementation phase is completed.
Active Comparator: aromatherapy-touch	Other: aromatherapy; Each of participants in the aromatherapy (inhalation) group will receive inhalation aromatherapy and those in the aromatherapy (massage) group will receive aromatherapeutic massage. As to the waiting control group, participants will be given either one of these two interventions after the implementation phase is completed.
No Intervention: waiting-list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS)	Numerical Rating Scale (NRS) will be used to measure the changes of pain among three time points within four months. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").	the change from baseline to the completion of intervention (16 weeks later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cantonese Version of the Mini-mental State Examination (CMMSE)	Cantonese Version of Mini-mental State Examination (MMSE) is a brief 30-point questionnaire used to assess the change of the cognitive functions among three time points at four months. The range of the score is from 0 point to 30 points, which a lower score indicates the worse cognitive functions.	baseline, 8 weeks after baseline, and 16 weeks after baseline
Chinese Version of the Barthel Index-100	Chinese Version of the Barthel Index-100 is used to measure the change of the performance in activities of daily living (ADL) among three time points at four months. Scores range from 0 to 100, with higher scores indicating greater independence.	baseline, 8 weeks after baseline, and 16 weeks after baseline
Index of Social Engagement(ISE)	The change of the social engagement among three time points at four months will be measured using the 6-item index of social engagement (ISE). Total scores on the ISE can range from 0 to 6, with a higher score indicating a higher level of social engagement.	baseline, 8 weeks after baseline, and 16 weeks after baseline
Profile of Mood States (POMS)- Shorterned Chinese Version	The Chinese abbreviated version of the Profile of Mood States will be used to subjective changes in mood states among three time points at four months. There are 40 items, where participants will rate on a scale of 0(not at all)-5(extremely) and higher score indicates more distress.	baseline, 8 weeks after baseline, and 16 weeks after baseline

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 25, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: P17-0203-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No