AromatherapyNCT07286825
Aromatherapy on Upper Limb Spasticity on Stroke Survivors
A study testing massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil and plain fractionated coconut organic carrier oil in people with Aromatherapy and Spasticity as Sequela of Stroke, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial summary
This study employed a double-arm, pre- and post-test design. Stroke survivors aged 65 or above with post-stroke upper limbs spasticity were recruited from two RCHEs in Hong Kong between February and June 2025, and were divided into control and intervention groups. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aromatherapy, Spasticity as Sequela of Stroke
- What is being tested?
- massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil and plain fractionated coconut organic carrier oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- he/she is communicable with either Chinese or English, and
- suffering from upper-limb post-stroke spasticity
Who cannot join
- he/she is currently receiving aromatherapy massage therapies
- he/she has external wound on the massage areas.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This study employed a double-arm, pre- and post-test design. Stroke survivors aged 65 or above with post-stroke upper limbs spasticity were recruited from two RCHEs in Hong Kong between February and June 2025, and were divided into control and intervention groups. 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 (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks. The range of motion (ROM) of the upper limbs in three planes, i.e., abduction, flexion and extension and pain level and blood pressure were assessed before and after each massage session. Psychosocial well-being of elders was assessed at baseline and 4 weeks post-intervention using Generalised Anxiety Disorder (GAD-7) and Patient Health Questionnaire (PHQ-9).
Read the 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.
- Conditions
- Aromatherapy, Spasticity as Sequela of Stroke
- Being tested
- massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil, plain fractionated coconut organic carrier oil
- Keywords
- aromatherapy massage, stroke survivors, upper limb spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oilCombination product
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.
plain fractionated coconut organic carrier oilCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil Receives: Combination Product: massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil |
| Control group | Active comparator | using massage oil with plain fractionated coconut organic carrier oil Receives: Combination Product: plain fractionated coconut organic carrier oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (ROM) on shoulder joints
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.
Measured: Before and after each massage session for 4 weeks in total
Secondary outcomes (2)
The Chinese Version of Generalised Anxiety Disorder (GAD-7)
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).
Measured: Week 0 and Week 4 after completing all massage sessions
Patient Health Questionnaire (PHQ-9)
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.
Measured: Week 0 and Week 4 after completing all massage sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Feb 2025
- Primary completion31 Jul 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AromatherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Veronica LAI Sze Ki, Hong Kong Metropolitan University
- Investigators
- Sze Ki Veronica LAI, Dr, Principal investigator, School of Nursing and Health Studies, Hong Kong Metropolitan Universit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286825
- Sponsor's protocol ID
- RD/2024/2.20
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The researchers will guarantee full confidentiality. All data will be kept 2 years after the project completion date. All soft copies of data will be destroyed by reformatting the disk (destroying everything on it). Hard copies will be destroyed by shredding then cross shredding.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07286825
- Acronym / sponsor ID
- RD/2024/2.20
- Conditions
- Aromatherapy, Spasticity as Sequela of Stroke
- Keywords
- aromatherapy massage, stroke survivors, upper limb spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study employed a double-arm, pre- and post-test design. Stroke survivors aged 65 or above with post-stroke upper limbs spasticity were recruited from two RCHEs in Hong Kong between February and June 2025, and were divided into control and intervention groups. 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 (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks. The range of motion (ROM) of the upper limbs in three planes, i.e., abduction, flexion and extension and pain level and blood pressure were assessed before and after each massage session. Psychosocial well-being of elders was assessed at baseline and 4 weeks post-intervention using Generalised Anxiety Disorder (GAD-7) and Patient Health Questionnaire (PHQ-9).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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 (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Combination Product: massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oilusing massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil |
| Control group | Active comparator | Combination Product: plain fractionated coconut organic carrier oilusing massage oil with plain fractionated coconut organic carrier oil |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- he/she is communicable with either Chinese or English, and
- suffering from upper-limb post-stroke spasticity
Key exclusion criteria (2 listed)
- he/she is currently receiving aromatherapy massage therapies
- he/she has external wound on the massage areas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil10-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. | Combination product | Intervention group |
| plain fractionated coconut organic carrier oil10-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. | Combination product | Control group |
Primary outcome
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.
2 secondary outcomes
The Chinese Version of Generalised Anxiety Disorder (GAD-7)
Time frame: Week 0 and Week 4 after completing all massage sessions
Patient Health Questionnaire (PHQ-9)
Time frame: Week 0 and Week 4 after completing all massage sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No. The researchers will guarantee full confidentiality. All data will be kept 2 years after the project completion date. All soft copies of data will be destroyed by reformatting the disk (destroying everything on it). Hard copies will be destroyed by shredding then cross shredding.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sze Ki Veronica LAI, Dr principal investigator
School of Nursing and Health Studies, Hong Kong Metropolitan Universit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil and plain fractionated coconut organic carrier oil in people with Aromatherapy and Spasticity as Sequela of Stroke, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (ROM) on shoulder joints (time frame: Before and after each massage session for 4 weeks in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.