Clinical Trials Directory

Trials / Completed

CompletedNCT07286825

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Hong Kong Metropolitan University · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTmassage 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_PRODUCTplain 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.

Timeline

Start date
2025-02-01
Primary completion
2025-07-31
Completion
2025-11-20
First posted
2025-12-16
Last updated
2025-12-16

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT07286825. Inclusion in this directory is not an endorsement.