Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities
Condition: Behavior Disturbance; Muscle Hypotonia
MeSH terms: Intellectual Disability; Muscle Hypotonia
Study type: Interventional

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.
    

Intervention name(s): Multisensory environment (MSE); Massage therapy (MT); Control group; Massage therapy in multisensory environment (MT-MSE)
Intervention type(s): Behavioral; Behavioral; Other; Behavioral
Intervention description(s): 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.; 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.; Usual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided.; Participants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks.
Other intervention name(s): Sensory stimulation; Snoezelen; Massage; Manual massage; Placebo; no intervention; Massage; Sensory environment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: massage; multisensory environment; challenging behaviours; relaxation