Clinical trial NCT03561844: Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Chronic Pain
Official title: Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: the change from baseline to the completion of intervention (16 weeks later)
Secondary outcomes:
measure: Cantonese Version of the Mini-mental State Examination (CMMSE)
timeFrame: baseline, 8 weeks after baseline, and 16 weeks after baseline
measure: Chinese Version of the Barthel Index-100
timeFrame: baseline, 8 weeks after baseline, and 16 weeks after baseline
measure: Index of Social Engagement(ISE)
timeFrame: baseline, 8 weeks after baseline, and 16 weeks after baseline
measure: Profile of Mood States (POMS)- Shorterned Chinese Version
timeFrame: baseline, 8 weeks after baseline, and 16 weeks after baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: