Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 73 for:    aromatherapy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03561844
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
TSANG Hector Wing-Hong, The Hong Kong Polytechnic University

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Other: aromatherapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Chronic Pain
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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



Primary Outcome Measures :
  1. Numerical Rating Scale (NRS) [ Time Frame: the change from baseline to the completion of intervention (16 weeks later) ]
    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 :
  1. Cantonese Version of the Mini-mental State Examination (CMMSE) [ Time Frame: baseline, 8 weeks after baseline, and 16 weeks after baseline ]
    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.

  2. Chinese Version of the Barthel Index-100 [ Time Frame: baseline, 8 weeks after baseline, and 16 weeks after baseline ]
    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.

  3. Index of Social Engagement(ISE) [ Time Frame: baseline, 8 weeks after baseline, and 16 weeks after baseline ]
    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.

  4. Profile of Mood States (POMS)- Shorterned Chinese Version [ Time Frame: baseline, 8 weeks after baseline, and 16 weeks after baseline ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561844


Locations
Layout table for location information
Hong Kong
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University

Layout table for additonal information
Responsible Party: TSANG Hector Wing-Hong, professor and head of rehabilitation science department, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03561844     History of Changes
Other Study ID Numbers: P17-0203-2
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms