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

NCT03561844 | Completed

• 1 other identifier: P17-0203-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cantonese Version of the Mini-mental State Examination (CMMSE)

  baseline, 8 weeks after baseline, and 16 weeks after baseline

• Chinese Version of the Barthel Index-100

  baseline, 8 weeks after baseline, and 16 weeks after baseline

• Index of Social Engagement(ISE)

  baseline, 8 weeks after baseline, and 16 weeks after baseline

• Profile of Mood States (POMS)- Shorterned Chinese Version

  baseline, 8 weeks after baseline, and 16 weeks after baseline

Study Arms (3)

aromatherapy-scent

ACTIVE COMPARATOR

Other: aromatherapy

aromatherapy-touch

ACTIVE COMPARATOR

Other: aromatherapy

waiting-list control

NO INTERVENTION

Interventions

aromatherapy OTHER

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.

aromatherapy-scent; aromatherapy-touch

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and head of rehabilitation science department

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: June 19, 2018
• Study Start: November 29, 2017
• Primary Completion: September 20, 2018
• Study Completion: October 1, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)