Impact of Foot Massage on Dementia Patients

This assignment delves into the impact of foot massage on individuals with dementia, focusing specifically on its effects on agitation and mood. It analyzes various randomized controlled trials (RCTs) that have investigated this topic, critically evaluating their methodologies and outcomes. The research aims to shed light on whether foot massage serves as a beneficial intervention for managing behavioral challenges associated with dementia.

Running head: RANDOMISED CONTROL TRIAL
Randomised control trial
Name of the student:
Name of the University:
Author’s note

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Screening question:
1.
Yes, the Randomized controlled trial (RCT) gave idea of a clearly focused issue on which
the research was conducted. The aim of the research was to compare the effect of foot massage
(intervention) and quiet presence (comparator and control) on agitation and mood in dementia
patient (population) (Moyle et al. 2014).
2.
Participants were randomized to treatment and control group. This can be understood by
the review of method section of the article which explained that block randomization was used to
achieve equality in the size of intervention and control groups. Allocation concealment was done
by randomizing participants by a computer program. Allocation was concealed from data
collection research assistants, care staffs and patient’s families (Moyle et al. 2014).
3.
Yes, the patients were analyzed in the groups to which they were randomized. This is
also understood because the trial was not stopped in between and all participants were followed
up between baseline and post-test. No participants were lost to follow up after being randomized
to treatment.
Detailed questions:
4.

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Yes, family’s health workers and study personnel were blinded to treatment. This is
understood as Moyle et al. (2014) mentioned about care staffs, data collections research assistant
and families in the section of randomization and blinding. The purpose of blinding in clinical
trial is to eliminate any impact of study findings due to different expectation of staffs (Schulz et
al. 2011). Treatment allocation is not revealed to many research staffs until they enter the trial to
prevent selection bias and any uninfluenced in study results because of knowledge about
concealment (Karanicolas, Farrokhyar and Bhandari 2010). Hence, it serves to prevent
differential treatment of the group at the onset of trial.
5.
The validity of any RCT study is understood by keeping the baseline variables same at
the start of the trial (Piantadosi 2017). This is understood by reviewing the ‘result’ section of the
stud which states that no difference in group at baseline were found for participants on the basis
of age, gender, time spend in facility, living condition, regular medication and PNR medication
for dementia patients. Example of baseline variables includes age, sex, social class, risk factors
and other adverse outcomes in participant. The advantage of keeping groups similar at the start
of the trial is that it helps to prevent baseline imbalance (Doig and Simpson 2014).
6.
The unique feature of a RCT study is that it tries to study the effect of an intervention by
randomization of participants to intervention and control group (Hayes and Moulton 2017). In
such studies, the only different between the intervention group and control group is the
intervention itself and other parameters are kept same (Latimer et al. 2017). In the RCT study by
Moyle et al. (2014), intervention group received foot massage and control group received quiet

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presence. However, other things such as duration of session, time frame of giving intervention
was kept same for the first treatment arm. As it used crossover study design, participants were
exposed to opposite treatment arm after the completion of first treatment arm. The advantage of a
cross-over design is that it reduces variability in participants as both types of treatment are
compared on the same patient (Apiliogullari and Onal 2015).
7.
The main purpose of the research study by Moyle et al. (2014) was to analyze the effect
of foot massage in dementia patients compared to those with quite presence. The size of the
treatment effect can be understood by the final outcome of the study. Both intervention and
control groups were evaluated on the outcome measure of assessing agitation and mood of
patients post the treatment. Agitation was assessed in participants by means of Cohen-Mansfield
Agitation Inventory Short Form (CMAI) and mood was evaluated by observed emotion rating
(OERS) scale. The validity of the RCT study is evident as the researcher also reported about the
consistency and inter-reliability of both the tools. Detailed description of both the tools and the
scale on which agitation and mood were evaluated was also comprehensively described by the
researcher (Moyle et al. 2014).
The primary outcome of the study was that the study showed that increase in agitation
was found in both group, however the effect was greater in the quiet presence group compared to
treatment group. The main reason for increase in total CMAI was the increase in the subscale of
verbal aggression. However, outcome remained same for OERS item and only difference was
found in general alertness in both groups. Therefore, slight effect of intervention was found in
foot massage group as had reduced alertness and agitation compared to control group. In

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addition, the research also gave idea about the variability in research finding due to difference in
the acceptance of treatment by participants, agitation due to unfamiliar assistants (Moyle et al.
(2014). Hence, all this is regarded as the confounding factors in the study that has affected the
efficacy of the foot massage intervention. The validity of the research finding is questionable
because it is not consistent with other studies. For instance, the pilot study by Moyle et al. (2013)
has revealed that foot massage significantly reduced levels of agitation in cognitively impaired
patients. Hence, the transferability of Moyle et al. (2014) is low due to inconsistency with other
research results and presence of confounding factors. Moyle et al. (2014) was also in favor of
foot massage to address stress in dementia patient as the findings shows that close presence of
another person promoted relaxation in patient.
8.
The estimate of the treatment effect is also understood by the method of statistical
analysis of the research data and confidence interval between outcomes in two groups. The
proportion of variance was illustrated and the result data mainly showed that there was more than
10% of variance in CMAI and OERS item indicating different factors playing complex role in
mood and agitation of individuals (Moyle et al. 2014). Hence, with data regarding means,
standard deviation and confidence interval at baseline and post-test for treatment and control
groups, the treatment effect was determined. Confidence interval is used by many health care
journals as it helps to identify whether a treatment has any effect or not (Freemantle et al. 2013).
The overall conclusion regarding the study finding is that desired results was not achieved by
providing foot massage to dementia patients and this is explained by some limitations in research
methods. For example, familiarity was an issue for many participants as they were disturbed by
the presence of a stranger in their room. Hence, if the researcher had considered about familiarity

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issues, then the research outcome would have been different. There is a need to focus on
conditions that will enhance the effect of foot massage (Oliver 2017).
9.
The results of the study cannot be applied in local context because inconsistent result has
been found for effect of foot massage on dementia patient. Certain confounding factors affected
the outcome and so it is necessary to do further research in this area by modifying the condition
under which the treatment was provided. However, moderate benefits were found and it may be
applied as there is no selection bias and similar participant group like real setting was selected
for the study. The inclusion criteria of taking 65 years above patient living in long-term care with
all having recent history of agitation eliminated selection bias. Research has shown that agitation
and aggressive behavior is frequently seen in dementia patients living in nursing homes (Husebo,
Ballard and Aarsland 2011).
10.
As the research mainly aimed to investigate about the effect of foot massage on agitation
and mood in dementia patients, the important clinical outcomes were considered by the
researcher. The main outcome variable for the study included agitation and mood and
appropriate evidence based tool was used evaluate agitation and mood of participants. For
example CMAI tool was used to assess agitation and this is a evidence that has been used in
many research related to agitated behavior. Cooke et al. (2010) used CMAI tool to analyze the
effect of music programme on agitation and anxiety in dementia patient.
11.

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Although the research did not achieved desired results, however the research has benefits
because it is the first trial that considered foot massage to address agitation in dementia patient
and it has highlighted the potential of foot massage only if the conditions in which the
intervention is provided is modified in the future. Hence, the benefits of the research are worth
the harm and the cost involved in doing the research. Aggressive behavior is a challenging issue
for dementia patient because as it has impact on social life of people. Therefore, research by
Kunik et al. (2010) is important as it focused on intervention to reduce aggression in dementia
patient.

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