Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Chronic Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
aromatherapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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.
Sites / Locations
- The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
aromatherapy-scent
aromatherapy-touch
waiting-list control
Arm Description
Outcomes
Primary Outcome Measures
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").
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT03561844
First Posted
June 8, 2018
Last Updated
January 23, 2019
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT03561844
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aromatherapy-scent
Arm Type
Active Comparator
Arm Title
aromatherapy-touch
Arm Type
Active Comparator
Arm Title
waiting-list control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
aromatherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
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").
Time Frame
the change from baseline to the completion of intervention (16 weeks later)
Secondary Outcome Measure Information:
Title
Cantonese Version of the Mini-mental State Examination (CMMSE)
Description
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.
Time Frame
baseline, 8 weeks after baseline, and 16 weeks after baseline
Title
Chinese Version of the Barthel Index-100
Description
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.
Time Frame
baseline, 8 weeks after baseline, and 16 weeks after baseline
Title
Index of Social Engagement(ISE)
Description
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.
Time Frame
baseline, 8 weeks after baseline, and 16 weeks after baseline
Title
Profile of Mood States (POMS)- Shorterned Chinese Version
Description
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.
Time Frame
baseline, 8 weeks after baseline, and 16 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Chronic Pain
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