Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000659808
Ethics application status
Approved
Date submitted
19/06/2012
Date registered
20/06/2012
Date last updated
20/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of foot massage on long-term care staff stress levels, anxiety, mood state, somatic symptoms and experiences of working with people with dementia
Scientific title
The effect of foot massage on long-term care staff stress levels, anxiety, mood state, somatic symptoms and experiences of working with people with dementia: A pilot randomized controlled trial.
Secondary ID [1] 280620 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress levels 286633 0
Anxiety 286738 0
Somatic Symptoms 286739 0
Condition category
Condition code
Mental Health 286916 286916 0 0
Other mental health disorders
Alternative and Complementary Medicine 286977 286977 0 0
Other alternative and complementary medicine
Mental Health 287039 287039 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Foot massage involving long gliding, rhythmical strokes of the entire foot and ankle, and light pressure massage by a certified therapist before the start of each of the staff participant rostered shifts over 4 weeks. All foot massages will be conducted in a quiet, separate room with a closed door displaying a ‘Do not disturb’ sign to enhance privacy and create a more conducive, therapeutic environment. The intervention consists of 5 minutes massage for each foot and depending on the number of shifts each participant works per week, participants will receive between 12-20 massages over the 4 week period. Following a 2-week ‘washout’ period of no activity, intended to reduce potential treatment carryover effects, participants will then ‘cross-over’ into the opposite treatment group and the protocol will be repeated for another 4 weeks.
Intervention code [1] 285061 0
Treatment: Other
Intervention code [2] 285118 0
Prevention
Comparator / control treatment
Control group (silent resting) will not receive foot massage but, instead, will sit with their eyes closed and legs slightly elevated off the floor resting on a stool/beanbag. This procedure will assist in the interpretation as to whether the foot massage specifically is having the hypothesised effects on participants or whether the effects reflect special attention and the opportunity for silent resting. To mirror the foot massage condition, the control activity will also be conducted in a quiet, separate room with a closed door displaying a ‘Do not disturb’ sign. Similarly, depending on the shift pattern of recruited care staff, silent resting will be experienced by each participant between 12-20 times over the 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 287312 0
Change in stress level - Perceived Stress Scale version 10 (PSS-10); a 10-item scale asking participants to rate, on a scale from '0-never' to '4-very often', the frequency with which they have experienced a number of instances of stress over the last month.
Timepoint [1] 287312 0
a) Pre-massage/rest intervention period (baseline)
b) Post-massage/rest intervention period (before cross over/wash-out)
c) Post-cross over treatment
Primary outcome [2] 287313 0
Change in mood states - The Profile Of Mood States- Bipolar (POMS-Bipolar) 15: a 72-item measure that makes up 6 bipolar subscales measuring both positive and negative affects. Participants rate each item on a 4-point scale that ranges from '0-much unlike this' to '3-much like this'.
Timepoint [2] 287313 0
a) Pre-massage/rest intervention period (baseline)
b) Post-massage/rest intervention period (before cross over/wash-out)
c) Post-cross over treatment
Primary outcome [3] 287314 0
Change in somatic symptoms - Patient Health Questionnaire-15 (PHQ-15) 17: a 15-item somatic symptom instrument that asks participants to rate the bother-someness of 15 symptoms on a scale of '0-not bothered at all' to '2-bothered a lot'.
Timepoint [3] 287314 0
a) Pre-massage/rest intervention period (baseline)
b) Post-massage/rest intervention period (before cross over/wash-out)
c) Post-cross over treatment
Secondary outcome [1] 297887 0
Change in staff experience - Staff Experience of Working with Demented Residents Questionnaire (SEWDRQ) 18: a 21-item assessment of staff experiences and satisfaction, and their relationship with other staff and relatives of residents with dementia. In the proposed study, the instrument will be modified to include culturally appropriate wording (i.e., 'patient' changed to 'resident').
Timepoint [1] 297887 0
a) Pre-massage/rest intervention period (baseline)
b) Post-massage/rest intervention period (before cross over/wash-out)
c) Post-cross over treatment
Secondary outcome [2] 297888 0
Physiological data - blood pressure and heart rate using an Omron HEM-7070 electronic sphygmomanometer, and temperature using a No Touch Temporal Artery Thermometer.
Timepoint [2] 297888 0
Pre- and post- each massage intervention and rest period

Eligibility
Key inclusion criteria
1. A member of staff providing direct care to residents (RNs; ENs; PCW)
2. Regularly working greater than or equal to 3 shifts per week
3. Ability & willingness to complete short, self-report rating scales on aspects of their health (i.e., stress, mood etc)
4. Ability & willingness to have their blood pressure, heart rate, temperature and anxiety recorded after each massage
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Night-shift care staff
2. Non care staff (i.e., cooks, maintenance workers etc)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure allocation concealment, a member of the research team not associated with data collection, will use a computer-generated program to randomly allocate participants to the order in which they will experience the intervention and control activities (i.e., foot massage [A] then silent resting [B] or silent resting [B] then foot massage [A]). A system of sequentially numbered, opaque sealed envelopes will be used to maintain allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer generated program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Firstly, all members of the research team will be blinded to group allocation, as will be contracted Research Assistants (RAs) undertaking all aspects of data collection. Secondly, whilst it is not possible to blind the participants themselves to the treatment they receive, they will be blinded to study hypotheses and proposed outcomes. Finally, other staff working at the LTC facility but not involved with the RCT will be blinded to group allocation, with participants asked not to discuss which treatment group they are in.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285425 0
Government body
Name [1] 285425 0
National Health and Medical Research Council (NHMRC) Dementia Research Grants Program
Country [1] 285425 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 284277 0
None
Name [1] 284277 0
Address [1] 284277 0
Country [1] 284277 0
Other collaborator category [1] 276867 0
Other
Name [1] 276867 0
Churches of Christ Residential Aged Care - Lady Small Haven
Address [1] 276867 0
60 Allchurch Avenue
Benowa
QLD 4217
Country [1] 276867 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287435 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 287435 0
Ethics committee country [1] 287435 0
Australia
Date submitted for ethics approval [1] 287435 0
Approval date [1] 287435 0
30/01/2012
Ethics approval number [1] 287435 0
NRS/54/09/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34269 0
Address 34269 0
Country 34269 0
Phone 34269 0
Fax 34269 0
Email 34269 0
Contact person for public queries
Name 17516 0
Professor Wendy Moyle
Address 17516 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 17516 0
Australia
Phone 17516 0
+61 (0) 7 3735 5526
Fax 17516 0
Email 17516 0
[email protected]
Contact person for scientific queries
Name 8444 0
Professor Wendy Moyle
Address 8444 0
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Country 8444 0
Australia
Phone 8444 0
+61 (0) 7 3735 5526
Fax 8444 0
Email 8444 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIThe effect of foot massage on long-term care staff working with older people with dementia: a pilot, parallel group, randomized controlled trial2013https://doi.org/10.1186/1472-6955-12-5
N.B. These documents automatically identified may not have been verified by the study sponsor.