search
Back to results

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

Primary Purpose

Behavior Disturbance, Muscle Hypotonia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Multisensory environment (MSE)
Massage therapy (MT)
Control group
Massage therapy in multisensory environment (MT-MSE)
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Behavior Disturbance focused on measuring massage, multisensory environment, challenging behaviours, relaxation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Siu Lam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Other

Active Comparator

Arm Label

Multisensory environment

Massage therapy

Control group

Massage in multisensory environment

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours
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)
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)
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.
Behavior Problem Inventory (BPI-01)
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
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
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
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.
Respiration and Pulse Rate
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.

Secondary Outcome Measures

Alertness Observation Checklist (AOC)
With the Alertness Observation Checklist (AOC), four levels of alertness of the participants can be distinguished: active, inactive and withdrawn, sleeping or drowsy, and agitated and discontented. Each level will be assigned with a color for presentation, including green for active level, orange for inactive and withdrawn state, red for sleepy or drowsy state, and blue for an agitated and discontented state. Frequency of alertness levels will be observed during the interventions. The averaged frequency is used for outcome analysis.
Alertness Observation Checklist (AOC)
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 5.
Alertness Observation Checklist (AOC)
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 10.
Alertness Observation Checklist (AOC)
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 12.
Behaviour Checklist (BC)
The Behaviour Checklist (BC) was developed by Shapiro et al. (1997) to assess the behavioral reactions toward multi-sensory environment and relevant psychological interventions. It consists of 22 items in which 16 items are for self-stimulating behaviours and 6 items for adaptive behaviours. Frequency of each of the listed behaviors in the checklist will be observed and counted at 1-minute intervals during the intervention sessions.
Behaviour Checklist (BC)
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 5.
Behaviour Checklist (BC)
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 10.
Behaviour Checklist (BC)
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 12.

Full Information

First Posted
April 16, 2014
Last Updated
August 8, 2017
Sponsor
The Hong Kong Polytechnic University
search

1. Study Identification

Unique Protocol Identification Number
NCT02120820
Brief Title
Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities
Acronym
MT-MSE
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 15, 2013 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Disturbance, Muscle Hypotonia
Keywords
massage, multisensory environment, challenging behaviours, relaxation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multisensory environment
Arm Type
Active Comparator
Arm Description
Multisensory environment (MSE): 30 minutes/session, twice a week for 10 weeks
Arm Title
Massage therapy
Arm Type
Active Comparator
Arm Description
Massage therapy (MT): 15 minutes/session, twice a week for 10 weeks
Arm Title
Control group
Arm Type
Other
Arm Description
Control group: usual care for 10 weeks, with attention and interactions with the caregivers only.
Arm Title
Massage in multisensory environment
Arm Type
Active Comparator
Arm Description
Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Multisensory environment (MSE)
Other Intervention Name(s)
Sensory stimulation, Snoezelen
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Massage therapy (MT)
Other Intervention Name(s)
Massage, Manual massage
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Placebo, no intervention
Intervention Description
Usual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Massage therapy in multisensory environment (MT-MSE)
Other Intervention Name(s)
Massage, Sensory environment
Intervention Description
Participants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks.
Primary Outcome Measure Information:
Title
Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours
Description
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.
Time Frame
Baseline (at recruitment)
Title
Behavior Problem Inventory (BPI-01)
Description
Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 5.
Time Frame
5 weeks after intervention started (interim assessment)
Title
Behavior Problem Inventory (BPI-01)
Description
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.
Time Frame
10 weeks after intervention started (Post-test 1)
Title
Behavior Problem Inventory (BPI-01)
Description
Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 12.
Time Frame
12 weeks after intervention started (Post-test 2)
Title
Respiration and Pulse Rate
Description
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.
Time Frame
Baseline (at recruitment)
Title
Respiration and Pulse Rate
Description
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.
Time Frame
5 weeks after intervention started (interim assessment)
Title
Respiration and Pulse Rate
Description
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.
Time Frame
10 weeks after intervention started (Post-test 1)
Title
Respiration and Pulse Rate
Description
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.
Time Frame
12 weeks after intervention started (Post-test 2)
Secondary Outcome Measure Information:
Title
Alertness Observation Checklist (AOC)
Description
With the Alertness Observation Checklist (AOC), four levels of alertness of the participants can be distinguished: active, inactive and withdrawn, sleeping or drowsy, and agitated and discontented. Each level will be assigned with a color for presentation, including green for active level, orange for inactive and withdrawn state, red for sleepy or drowsy state, and blue for an agitated and discontented state. Frequency of alertness levels will be observed during the interventions. The averaged frequency is used for outcome analysis.
Time Frame
Baseline (At recruitment)
Title
Alertness Observation Checklist (AOC)
Description
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 5.
Time Frame
5 weeks after intervention started (interim assessment)
Title
Alertness Observation Checklist (AOC)
Description
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 10.
Time Frame
10 weeks after intervention started (Post-test 1)
Title
Alertness Observation Checklist (AOC)
Description
Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 12.
Time Frame
12 weeks after intervention started (Post-test 2)
Title
Behaviour Checklist (BC)
Description
The Behaviour Checklist (BC) was developed by Shapiro et al. (1997) to assess the behavioral reactions toward multi-sensory environment and relevant psychological interventions. It consists of 22 items in which 16 items are for self-stimulating behaviours and 6 items for adaptive behaviours. Frequency of each of the listed behaviors in the checklist will be observed and counted at 1-minute intervals during the intervention sessions.
Time Frame
Baseline (at recruitment)
Title
Behaviour Checklist (BC)
Description
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 5.
Time Frame
5 weeks after intervention started (interim assessment)
Title
Behaviour Checklist (BC)
Description
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 10.
Time Frame
10 weeks after intervention started (Post-test 1)
Title
Behaviour Checklist (BC)
Description
Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 12.
Time Frame
12 weeks after intervention started (Post-test 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Tong CHIEN, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siu Lam Hospital
City
Tuen Mun
State/Province
New Territories
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28387017
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.
Results Reference
result

Learn more about this trial

Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities

We'll reach out to this number within 24 hrs