- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286825
Aromatherapy on Upper Limb Spasticity on Stroke Survivors
The Effects of Aromatherapy on Upper Limb Spasticity and Psychosocial Well-being on Stroke Survivors in Residential Care Homes for the Elderly: A Pilot RCT
Study Overview
Status
Conditions
Detailed Description
Study design This study employed a double-arm, pre- and post-test design. The study was conducted in two RCHEs in Hong Kong under a non-government organisation, Po Leung Kuk (PLK).
Participants We took reference from a pilot RCT on the effect of aromatherapy acupressure on hemiplegic shoulder and motor power among stroke patients recruited 30 patients (15 control and 15 intervention) (Shin & Lee, 2007). In our study, 30 elders aged 65 or above with post-stroke upper limbs spasticity were recruited from two RCHEs in Hong Kong and evenly divided in both control and intervention groups (please refer to CONSORT flowchart in Fig. 2). Among both groups, only two elders from the control group dropped out due to admission to hospital during the research period. Participants were considered eligible if: (1) he/she is communicable with either Chinese or English, and (2) suffering from upper-limb post-stroke spasticity. In addition, participants will be excluded if: (1) he/she is currently receiving aromatherapy massage therapies, (2) he/she has external wound on the massage areas.
An information sheet was given, and consent was sought from each carer and elder before the intervention. All elders and carers were free to withdraw consent at any time. Where possible, clarification on the specific area of withdrawal, but not obligatory. Previously collected data was use in the analyses.
Procedures A 10-minute massage was given on elders' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks (8 sessions in total). Massage steps and rhythm and intensity are standardised for all subjects. Range of motion (ROM) and pain level was measured before and after each session of massage and psychosocial well-being will be measured at baseline and 4 weeks after the intervention.
Upper limb massage steps were standardized as follow:
Effleurage was done on the upper limbs and shoulders with mild pressure using hands, which mould themselves to the shape of the body being massaged (Price et al., 2020). 5-Step massage was done with sweet marjoram massage oil on both upper limbs as well as shoulders (as shown below). Whole massage process lasted for 10-15 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Hong Kong Metropolitan University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- he/she is communicable with either Chinese or English, and
- suffering from upper-limb post-stroke spasticity
Exclusion Criteria:
- he/she is currently receiving aromatherapy massage therapies
- he/she has external wound on the massage areas.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention group
using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil
|
10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil.
|
|
Active Comparator: Control group
using massage oil with plain fractionated coconut organic carrier oil
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10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using plain fractionated coconut organic carrier oil as massage oil.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of motion (ROM) on shoulder joints
Time Frame: Before and after each massage session for 4 weeks in total
|
Range of motion (ROM) will be assessed on shoulder joints as the primary outcome.
The shoulder complex consists of four joints: the glenohumeral (GH), sternoclavicular (SC), acromioclavicular (AC) and scapulothoracic joints.
The ROM of shoulder requires coordinated motion of all these joint.
To evaluate the functional ROM of the shoulder, a goniometer will be used for measuring the passive or active ROM values (degrees) before and after each week of massage for 4 weeks in total.
Abduction, flexion and extension ROM will be measured.
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Before and after each massage session for 4 weeks in total
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Chinese Version of Generalised Anxiety Disorder (GAD-7)
Time Frame: Week 0 and Week 4 after completing all massage sessions
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The Chinese version of GAD-7 will be used for assessing the anxiety level severity in clinical practice (Spitzer et al., 2006).
It consists of seven items; each item is scored from 0 to 3 with the total score ranges from 0 to 21.
The internal consistency of the GAD-7 was excellent (Cronbach' α = .92).
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Week 0 and Week 4 after completing all massage sessions
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Patient Health Questionnaire (PHQ-9)
Time Frame: Week 0 and Week 4 after completing all massage sessions
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The Chinese version of PHQ-9, which is widely used in different community settings for depression screening, will be used.
PHQ-9 consists of nine-item depression module with internal consistency (Cronbach' α) of α =0.87.
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Week 0 and Week 4 after completing all massage sessions
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Collaborators and Investigators
Investigators
- Principal Investigator: Sze Ki Veronica LAI, Dr, School of Nursing and Health Studies, Hong Kong Metropolitan Universit
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD/2024/2.20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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