An Evaluation of the Clinical Efficacy of Massage Therapy in a Multisensory Environment for Residents With Severe and Profound Intellectual Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours
研究概览
简要总结
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:
- 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.
- 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.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Multisensory environment
Multisensory environment (MSE): 30 minutes/session, twice a week for 10 weeks
干预措施: Multisensory environment (MSE) (Behavioral)
Massage therapy
Massage therapy (MT): 15 minutes/session, twice a week for 10 weeks
干预措施: Massage therapy (MT) (Behavioral)
Control group
Control group: usual care for 10 weeks, with attention and interactions with the caregivers only.
干预措施: Control group (Other)
Massage in multisensory environment
Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks.
干预措施: Multisensory environment (MSE) (Behavioral)
Massage in multisensory environment
Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks.
干预措施: Massage therapy (MT) (Behavioral)
Massage in multisensory environment
Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks.
干预措施: Massage therapy in multisensory environment (MT-MSE) (Behavioral)
结局指标
主要结局
Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours
时间窗: Baseline (at recruitment)
BPI-01 consists of 49 items with three subscales and has been widely employed in people with intellectual disability who are living in residential settings. This instrument is to evaluate the frequency and severity of challenging behaviours over the past two weeks of each assessment time points. Each item of the scale can be assessed on both frequency and severity of each kind of behaviour. The frequency scale is a 5-point rating scale: 0 - never, 1 - monthly, 2 - weekly, 3 - daily, and 4 - hourly. The severity scale is a 4-point Likert scale, denoted by: 0 - no problem, 1 - a slight problem, 2 - a moderate problem, and 3 - a severe problem. If a resident does not exhibit any behaviour listed in the item, "never" and "no problem" should be rated on that item.
Behavior Problem Inventory (BPI-01)
时间窗: 12 weeks after intervention started (Post-test 2)
Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 12.
Respiration and Pulse Rate
时间窗: 12 weeks after intervention started (Post-test 2)
Respiration rate and heart (pulse) rate will be measured 3 minutes by the end of week 12. Their average values will be used for outcome analysis.
Behavior Problem Inventory (BPI-01)
时间窗: 5 weeks after intervention started (interim assessment)
Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 5.
Behavior Problem Inventory (BPI-01)
时间窗: 10 weeks after intervention started (Post-test 1)
Behavior Problem Inventory (BPI-01) (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 10.
Respiration and Pulse Rate
时间窗: Baseline (at recruitment)
Relaxation is a state of parasympathetic activation by vagal nerve, and suppressing the activity of sympathetic nervous system. If massage therapy and/or MSE indicate relaxation effect, the physiological parameters, i.e. pulse and respiration rates, are expected to drop to a lower level as compared with baseline readings after the interventions. Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions. Their average values will be used for outcome analysis.
Respiration and Pulse Rate
时间窗: 5 weeks after intervention started (interim assessment)
Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions by the end of week 5. Their average values will be used for outcome analysis.
Respiration and Pulse Rate
时间窗: 10 weeks after intervention started (Post-test 1)
Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions by the end of week 10. Their average values will be used for outcome analysis.
次要结局
- Alertness Observation Checklist (AOC)(12 weeks after intervention started (Post-test 2))
- Behaviour Checklist (BC)(12 weeks after intervention started (Post-test 2))
- Alertness Observation Checklist (AOC)(Baseline (At recruitment))
- Alertness Observation Checklist (AOC)(5 weeks after intervention started (interim assessment))
- Alertness Observation Checklist (AOC)(10 weeks after intervention started (Post-test 1))
- Behaviour Checklist (BC)(Baseline (at recruitment))
- Behaviour Checklist (BC)(5 weeks after intervention started (interim assessment))
- Behaviour Checklist (BC)(10 weeks after intervention started (Post-test 1))
研究者
Wai-Tong Chien
Professor
The Hong Kong Polytechnic University