Clinical trial NCT02120820: Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities
Official title: An Evaluation of the Clinical Efficacy of Massage Therapy in a Multisensory Environment for Residents With Severe and Profound Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior Disturbance
Muscle Hypotonia
Keywords: massage
multisensory environment
challenging behaviours
relaxation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours
timeFrame: Baseline (at recruitment)
measure: Behavior Problem Inventory (BPI-01)
timeFrame: 5 weeks after intervention started (interim assessment)
measure: Behavior Problem Inventory (BPI-01)
timeFrame: 10 weeks after intervention started (Post-test 1)
measure: Behavior Problem Inventory (BPI-01)
timeFrame: 12 weeks after intervention started (Post-test 2)
measure: Respiration and Pulse Rate
timeFrame: Baseline (at recruitment)
measure: Respiration and Pulse Rate
timeFrame: 5 weeks after intervention started (interim assessment)
measure: Respiration and Pulse Rate
timeFrame: 10 weeks after intervention started (Post-test 1)
measure: Respiration and Pulse Rate
timeFrame: 12 weeks after intervention started (Post-test 2)
Secondary outcomes:
measure: Alertness Observation Checklist (AOC)
timeFrame: Baseline (At recruitment)
measure: Alertness Observation Checklist (AOC)
timeFrame: 5 weeks after intervention started (interim assessment)
measure: Alertness Observation Checklist (AOC)
timeFrame: 10 weeks after intervention started (Post-test 1)
measure: Alertness Observation Checklist (AOC)
timeFrame: 12 weeks after intervention started (Post-test 2)
measure: Behaviour Checklist (BC)
timeFrame: Baseline (at recruitment)
measure: Behaviour Checklist (BC)
timeFrame: 5 weeks after intervention started (interim assessment)
measure: Behaviour Checklist (BC)
timeFrame: 10 weeks after intervention started (Post-test 1)
measure: Behaviour Checklist (BC)
timeFrame: 12 weeks after intervention started (Post-test 2)
Other outcomes:
Locations:
city: Tuen Mun
country: Hong Kong
facility: Siu Lam Hospital
state: New Territories
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Wai Tong CHIEN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.