Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities (MT-MSE)

The Hong Kong Polytechnic University

Status: Completed

Conditions: Muscle Hypotonia; Behavior Disturbance

Treatments: Other: Control group; Behavioral: Massage therapy in multisensory environment (MT-MSE); Behavioral: Multisensory environment (MSE); Behavioral: Massage therapy (MT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02120820

HongKongPU

Details and patient eligibility

About

The aim of this study is to evaluate the effectiveness of multisensory environment (MSE) and/or massage therapy (MT) in residents with severe and profound intellectual disabilities (ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual care environment, or usual care with attention.

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.

Full description

Design:

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• exhibiting at least one type of challenging behavior
• 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

• seriously ill or completely bed-rest residents
• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 4 patient groups

Multisensory environment

Active Comparator group

Description:

Multisensory environment (MSE): 30 minutes/session, twice a week for 10 weeks

Treatment:

Behavioral: Multisensory environment (MSE)

Massage therapy

Active Comparator group

Description:

Massage therapy (MT): 15 minutes/session, twice a week for 10 weeks

Treatment:

Behavioral: Massage therapy (MT)

Control group

Other group

Description:

Control group: usual care for 10 weeks, with attention and interactions with the caregivers only.

Treatment:

Other: Control group

Massage in multisensory environment

Active Comparator group

Description:

Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks.

Treatment:

Behavioral: Massage therapy (MT)

Behavioral: Multisensory environment (MSE)

Behavioral: Massage therapy in multisensory environment (MT-MSE)