Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities
NCT ID: NCT02120820
Last Updated: 2017-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2013-04-15
2017-07-31
Brief Summary
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Since there has not yet been any conclusive evidence to show the clinical efficacy of MT and MSE on relaxation and reducing challenging behaviours, the following null hypotheses are suggested:
1. There will not be any differences on reducing heart and respiration rates between MT-MSE, MT, MSE, and usual care only over the 10-week intervention period and a 2-week follow-up.
2. There will not be any differences on adaptive behaviours and levels of alertness between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week follow-up.
3. There will not be any differences on frequency and severity of challenging behaviours between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week follow-up.
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Detailed Description
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This study adopts a mixed methods research design, in which both quantitative (i.e., randomized controlled trial design) and qualitative (exploratory) approaches will be used.
Methods:
After the study criteria are checked and met and proxy consent has been obtained, the participants will undergo a period of washout (4 weeks) from the current multisensory environment (MSE) and/or massage therapy (MT) sessions. After that, the baseline measurement of all outcome measures will be taken. All of them will then be randomly assigned to one of the four study groups, including three treatment groups, namely massage therapy in MSE (MT-MSE), MSE only and massage therapy in usual care environment (MT), and one control (routine care) group.
The effects of the three proposed interventions and routine care only groups on the study outcomes, including frequency and severity of challenging behaviour, adaptive behaviour, alertness level, and heart and respiration rate, will be compared between groups at baseline, interim (i.e., 5 weeks after the interventions started), immediately after completion of the interventions (i.e. 10 weeks after the interventions started), and 2 weeks follow up (i.e. at 12 weeks from the start of intervention, but no intervention at week 11 and 12). A pilot study will be conducted to review the feasibility and clarity of the study procedure, intervention protocols, and outcome measurements in around 30 patients with similar clinical characteristics (i.e., 8 subjects per groups) before starting the main study.
Primary outcomes of the study are frequency and severity of challenging behaviours, and the physiological signs (i.e., respiration and pulse rate). The secondary outcomes are the levels of alertness and adaptive behaviours.
Primary nurses who are responsible to formulate the individualized MSE and/or MT programs of the participants in the three treatment groups will be invited to participate a face-to-face semi-structured interview in order to explore their perceptions and opinions towards the strengths and limitations of the intervention(s) used, factors influencing the challenging behaviours of the disabled residents, and their suggested strategies in reducing their clients' challenging behaviours in their work setting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Multisensory environment
Multisensory environment (MSE): 30 minutes/session, twice a week for 10 weeks
Multisensory environment (MSE)
Participants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session.
Massage therapy
Massage therapy (MT): 15 minutes/session, twice a week for 10 weeks
Massage therapy (MT)
A trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler.
Control group
Control group: usual care for 10 weeks, with attention and interactions with the caregivers only.
Control group
Usual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided.
Massage in multisensory environment
Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks.
Multisensory environment (MSE)
Participants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session.
Massage therapy (MT)
A trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler.
Massage therapy in multisensory environment (MT-MSE)
Participants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks.
Interventions
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Multisensory environment (MSE)
Participants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session.
Massage therapy (MT)
A trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler.
Control group
Usual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided.
Massage therapy in multisensory environment (MT-MSE)
Participants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* admitted at least 3 months for long-term care
* being dependent on nursing care and physical assistance in daily activities
* aged 18 to 64 years
Exclusion Criteria
* having infectious diseases
* frequently discharged to general hospital for acute care
* frequent home or day leave
* having pressure ulcer and/or severe contracture and deformity
* being restless and reluctant to stay in multisensory environment, or receive massage therapy
18 Years
64 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Wai-Tong Chien
Professor
Principal Investigators
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Wai Tong CHIEN, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hong Kong Polytechnic University
Locations
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Siu Lam Hospital
Tuenmen, New Territories, Hong Kong
Countries
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References
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Chan JSL, Chien WT. A randomised controlled trial on evaluation of the clinical efficacy of massage therapy in a multisensory environment for residents with severe and profound intellectual disabilities: a pilot study. J Intellect Disabil Res. 2017 Jun;61(6):532-548. doi: 10.1111/jir.12377. Epub 2017 Apr 7.
Other Identifiers
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HongKongPU
Identifier Type: -
Identifier Source: org_study_id
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