The effect of foot massage on agitation in people with dementia living in residential care.

Not Applicable

Completed

• Conditions: Agitated behaviours in people with dementia; Mental Health - Other mental health disorders; Neurological - Dementias; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12612000658819
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) informed consent (i.e., authority received from resident’s themselves and/or relatives and health attorneys to join the research)
2) permanent residence in one of the four chosen residential care facilities in the Brisbane area of South East Queensland for at least 2 months
3) two feet, excluding artificial legs
4) no specific medical-related contraindications (e.g., recent surgery to the area, vessel embolism, peripheral neuropathy, painful bunions or acute illness)
5) a diagnosis of dementia, or met the criteria for probable dementia of Alzheimer’s type as per DSM-IV
6) a Mini Mental State Exam (MMSE) score of < 18 indicating moderate to severe dementia
7) a documented history of agitation on nursing or medical records within the previous two weeks
8) a score of >3 points on the PAS 30 during each day over a period of one week. (the screening component of the PAS is used here and the full observation is used in the data collection)

Exclusion Criteria

1) consent unobtainable
2) those that are not residents of the care facilities chosen for this trial
3) not having two feet
4) those that have specific medical-related contraindications (e.g., recent surgery to the area, vessel embolism, peripheral neuropathy, painful bunions or acute illness)
5) no diagnosis of dementia, or not met the criteria for probable dementia of Alzheimer’s type as per DSM-IV
6) a Mini Mental State Exam (MMSE) score of > 18
7) a score of <3 points on the PAS 30 during each day over a period of one week.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of Agitation using Pittsburgh Agitation Scale (PAS) and Cohen-Mansfield Agitation Inventory (CMAI).[a) Pre-massage/quiet presence intervention period (baseline)<br>b) Post-massage/quiet presence intervention period (before cross over/wash-out)<br>c) Post-cross over treatment]

Secondary Outcome Measures

Name	Time	Method
Measure of Depression using the Geriatric Depression Scale (GDS)[a) Pre-massage/quiet presence intervention period (baseline)<br>b) Post-massage/quiet presence intervention period (before cross over/wash-out)<br>c) Post-cross over treatment];Measure of Emotion and Discomfort using Observed Emotion Rating Scale (OERS) and Discomfort Scale for Dementia of the Alzheimer's Type (DSD).[a) Pre-massage/quiet presence intervention period (baseline)<br>b) Post-massage/quiet presence intervention period (before cross over/wash-out)<br>c) Post-cross over treatment];Measure of physiologic stress by monitoring blood pressure and heart rate using an Omron HEM-7070 electronic sphygmomanometer and body temperature using a No Touch Temporal Artery Thermometer.[Pre- and post- each massage intervention and quiet presence]