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1. J Ren Care. 2021;1–10. wileyonlinelibrary.com/journal/jorc | 1
Received: 2 December 2019 | Revised: 10 March 2021 | Accepted: 18 March 2021
DOI: 10.1111/jorc.12372
O R I G I N A L R E S E A R C H
A nonrandomised pilot study to examine the feasibility
and acceptability of reflexology in patients undergoing
hospital‐based haemodialysis (solitude study)
Michael Matthews MSc, PhD student1
| Claire Carswell BSc2
|
Avril Redmond BSc3
| Stephanie Bolton MB, BcH, BaO, MRCP, PGD (Med Ed)3
|
Kim Murphy BSc3
| Robert Mullan MB, BCh, BAO, MD3
| Helen McAneney PhD4
|
Clare McKeaveney PhD1
| Helen Noble PhD1
1
School of Nursing and Midwifery, Queen's
University, Belfast, UK
2
Department of Health Sciences, University of
York, York, UK
3
Renal Unit, Antrim Area Hospital, Northern
Health and Social Care Trust, Antrim, UK
4
School of Medicine, Dentistry and
Biomedical Sciences, Queen's University,
Belfast, UK
Correspondence
Michael Matthews, MSc, PhD student, School
of Nursing and Midwifery, Queen's University,
Belfast, Northern Ireland, UK.
Email: mmatthews01@qub.ac.uk
Funding information
Northern Health and Social Care Trust,
Grant/Award Number: Research and
Development Fund
Abstract
Background: Patients with end‐stage kidney disease, receiving haemodialysis can
experience complications—hypotension, headache, muscle cramp, chest pain, nausea
and vomiting. Patients who experience all or some of these symptoms will often
report reduced health‐related quality of life (HRQOL) and poor sleep quality, which
may lead to increased morbidity and mortality.
Objective: The objective of this pilot study is to evaluate the feasibility of a larger
randomised controlled trial to determine the effect of foot reflexology on a cohort
of patients undergoing hospital‐based haemodialysis.
Design: A nonrandomised pilot study using a multimethod approach.
Participants: Twenty patients undergoing hospital‐based haemodialysis treatment.
Measurements: HRQOL and quality of sleep were measured using the SF‐12 Health
Survey and the Pittsburgh Sleep Quality Index (PSQI). Semi‐structured interviews
were completed with 10 patients, exploring their experiences, opinions and per-
ceptions of the intervention.
Results: There was an increase in the mean scores examining the total physical
health and mental health components of the SF‐12. All corresponding p values were
statistically significant following the intervention. The mean total sleep score
postintervention signified positive changes in sleep quality, with the corresponding
p values being statistically significant. The study established the feasibility of the
intervention and the benefits for patients undergoing haemodialysis.
Conclusion: This pilot study demonstrated the possibility of recruiting and retaining
patients undergoing haemodialysis to a reflexology study. The study did not impact
the haemodialysis routine and was positively received. The intervention showed
statistically significant improvements in patients' HRQOL and sleep quality.
This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any
medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
© 2021 The Authors. Journal of Renal Care published by John Wiley & Sons Ltd on behalf of European Dialysis & Transplant Nurses Association/European Renal Care
Association

2. K E Y W O R D S
haemodialysis, health related quality of life, pilot study, reflexology, sleep quality
INTRODUCTION
The increasing prevalence of chronic diseases is a substantial
problem facing healthcare services (Sharifi et al., 2018). The in-
cidence of kidney failure is increasing and causes significant
distress to patients, resulting in increased hospital admissions,
loss of productivity, morbidity and early mortality (Elshahat
et al., 2020). The prevalence of this disease in developing coun-
tries is on a growing trend, with the diagnosis being ranked 16th
among the leading causes of death in 2016 and is expected to
increase to being ranked 5th in 2040 (Foreman et al., 2018).
Chronic kidney disease is classified based on abnormal urinalysis
and/or renal tract structure and progresses along a five‐stage
trajectory. Stage 5 kidney failure (Elshahat et al., 2020) occurs
when the glomerular filtration rate of the kidney is less than
15 ml/min, thus necessitating the need for haemodialysis, peri-
toneal dialysis or transplantation (Levey & Coresh, 2012). In
2016, there were 63,162 adult patients receiving renal replace-
ment therapy in the United Kingdom (Byrne et al., 2018). Glob-
ally the number of people with kidney failure receiving renal
replacement therapy is estimated to increase from 2.6 million in
2010 to 5.4 million by 2030 (Liyanage et al., 2015). Haemodia-
lysis remains the most common treatment for 70% of patients
worldwide with kidney failure. Given the 5%–6% growth of
haemodialysis patients consistent with the global growth of
kidney failure patients, haemodialysis is expected to remain the
most common treatment for this group of patients. Despite sig-
nificant medical advances over several decades, the survival of
patients on haemodialysis therapy remains shorter than that of
the general population (Rydell et al., 2019). Patients receiving
haemodialysis experience lower health‐related quality of life
(HRQoL) and physical functioning as compared with individuals
with normal kidney function (Murtagh et al., 2007). Most re-
search focused on improving health outcomes for patients on
haemodialysis has focused on pharmacotherapy and the actual
haemodialysis prescription (Himmelfarb & Ikizler, 2011), while
there is limited data on the use of complementary therapies
among patients with kidney failure receiving haemodialysis and
its impact on the quality of life and symptoms.
LITERATURE REVIEW
Despite technical advances and changes in the way haemodialysis is
delivered, it remains a challenging, arduous treatment for many patients
(Lowney et al., 2015). Common complications of haemodialysis include
hypotension, muscle cramps, nausea and vomiting, headache, chest pain
and back pain, all of which potentially have a drastic effect on both the
physical and mental well‐being of patients receiving haemodialysis
(Asgari et al., 2017). In most patients undergoing haemodialysis, these
complications can be associated with a reduction in blood pressure and
disequilibrium during the treatment (Naseri‐Salahshour et al., 2019).
Patients who experience some or all of the symptoms outlined will often
report reduced HRQOL (Naseri‐Salahshour et al., 2019), including poor
sleep quality (Bonner et al., 2010).
In national and international studies, fatigue has been reported in
more than half the patients receiving haemodialysis (Almutary
et al., 2013; Davey et al., 2019; Sharifi et al., 2018). Fatigue is a subjective
experience in which a person experiences a persistent general feeling of
reduced capacity for mental and physical functioning and is also an im-
portant predictor for the survival of haemodialysis patients (Davey
et al., 2019). It has been reported that between 50% and 80% of patients
undergoing haemodialysis experience poor sleep quality or suffer from
sleep disorders (Turek et al., 2012). The association between inadequate
sleep quality and poor mental health, reduced (HRQoL) and increased
morbidity and mortality for patients undergoing haemodialysis cannot be
underestimated. Furthermore, it may have a direct effect on the dete-
rioration of kidney function in patients undergoing haemodialysis treat-
ment who experience more sleep problems than healthy adults (Colbay
et al., 2007; Edley, 2020; Merlino et al., 2008). Patients undergoing
haemodialysis therapy most commonly present with headache, back pain,
musculoskeletal pain or muscle cramp (Davison & Jhangri, 2010). Chronic
pain in patients receiving haemodialysis treatment often lacks a treatable
underlying cause, and the somatosensory component of the pain as-
sumes greater prominence than in acute pain.
There is increasing evidence that complications experienced by
patients receiving haemodialysis are the most important predictor of
HRQOL (Almutary et al., 2013). Complications, such as muscle cramp,
pain and nausea and vomiting, make haemodialysis unpleasant for pa-
tients and thus may lead to the early discontinuation of haemodialysis,
thereby creating an undesirable inadequacy of haemodialysis despite its
high costs (Weisbord et al., 2014). Self‐confidence may be affected, im-
pacting significantly on work performance, family relationships and daily
routine of life (Picariello et al., 2019). Haemodialysis complications re-
duce patient HRQOL and quality and amount of sleep. Preventing or
minimising such complications will ultimately lead to an increase in pa-
tient HRQOL, improved sleep quality and greater longevity (Naseri‐
Salahshour et al., 2019; Unal & Akpinar, 2016).
Complementary therapies are used to describe treatments, which
are employed alongside or integrated with orthodox medical treatment
with the aim of providing physical, psychological and emotional support
through the relief of symptoms (Sharifi et al., 2018). Even though non-
pharmacological methods have attracted the attention of patients and
their caregivers to control some of the symptoms of chronic diseases, the
dominance of the conventional medical profession continues to limit the
inclusion from some chronic disease groups, one such group being pa-
tients undergoing haemodialysis therapy (Sharifi et al., 2018). The use of
complementary therapies in patients undergoing haemodialysis
2 | MATTHEWS ET AL.

3. treatment is reported to be relatively infrequent (Bahall, 2017) in con-
trast to other chronic disease groups, such as cancer, where it is a sig-
nificant and growing phenomenon (Candy et al., 2020). In healthcare,
reflexology is probably one of the most frequently used complementary
therapies (Candy et al., 2020). Reflexology is the systematic application of
pressure to specific reflex points on the feet or hands with the intention
of promoting homoeostasis (Korkan & Uyar, 2014). Foot massage is
considered a safe and inexpensive method and has significantly dimin-
ished fatigue in haemodialysis (Wilhelm, 2009).
The main mechanism of the reflexology is its effect on the
nervous system. Working from the premise that reflex areas in
the foot are linked to principal organs and glands via energy
zones, it is presumed that the application of pressure to these
areas stimulates nerve reflexes, which are transmitted to the
brain. The brain reacts by restoring the proper flow of blood so
that haemostasis of the body can be maintained. This stimulation
and manipulation, therefore, help to maintain haemostasis by
provoking the chemical system of the nerves, balancing the en-
zymes and regulating endocrine function (Wilkinson et al., 2008).
Many studies have been carried out, highlighting the benefits of
reflexology (Nesami et al., 2014; Rigi et al., 2015; Unal &
Akpinar, 2016). These studies have shown that reflexology can
reduce nausea, vomiting, pain, anxiety, fatigue and sleeplessness
in many conditions, including migraine, pre‐ and postnatal dis-
comfort, cancer, and chronic obstructive pulmonary disease
(Wang et al., 2008) and (Yang, 2005). Reflexology may lead to
increased well‐being amongst patients undergoing haemodialysis
treatment. In patients receiving haemodialysis, studies have
shown that reflexology has proven effective in relation to cramp,
fatigue, and emotional issues. The evidence base, however, is
limited and further research is required (Ozdemir et al., 2013;
Unal & Akpinar, 2016).
The aim of this pilot study was to evaluate the feasibility of a
larger randomised controlled trial to determine the effect of foot
reflexology on patients undergoing hospital‐based haemodialysis
with a non‐randomised pilot study using multimethods. This was
achieved by evaluating the feasibility of patient recruitment within a
single haemodialysis setting for a definitive trial and the feasibility of
delivering foot reflexology as a component of treatment in a hae-
modialysis setting. Outcome measures used in the evaluation were
determined by completion rates and missing data. Analysis of the
collected data was conducted to identify potential outcome mea-
sures to evaluate the effectiveness of reflexology in a definitive trial.
METHODS
Research design
Although traditionally quantitative and qualitative methodolo-
gies have been viewed as two distinctly different paradigms
(Parahoo, 2014), there are areas of inquiry, which can be
enhanced by using a combination of both methods
(Polit & Beck, 2012). Hence both approaches have been included
in this study. The study protocol was approved by the local
Research Ethics Committee (REC reference: 17/NI/0244). The
study was a non‐randomised pilot study that used a multimethod
approach to explore the feasibility of a reflexology intervention
for patients receiving hospital‐based haemodialysis. Non‐
randomised pilot studies are used to explore the feasibility of
intervention and certain aspects of evaluation, such as recruit-
ment and the appropriateness of outcome measures, without
randomly allocating participants to a control and intervention
group (Eldridge et al., 2016).
User involvement
This study was developed in collaboration with members of the
Northern Ireland Kidney Patient Association (NIKPA), who have
personal knowledge and experience of kidney disease and of-
fered insightful input and perspective. An advisory group was
established to support the study, which included service users,
renal healthcare staff, policy makers, key stakeholders and aca-
demics from Queen's University, Belfast. Contact with these in-
dividuals was made by e‐mail. The advisory group that met
quarterly, provided expertise and a strategic view on the devel-
opment of the research. They helped to identify emerging issues
such as those related to the ethical understanding of the work
and how best one might respond to these.
Participants and setting
The study population were patients with kidney failure who were
receiving hospital‐based haemodialysis in a rural renal unit in
Northern Ireland during the period of January–April 2018. Male or
female patients >18 years of age were recruited.
Exclusion criteria
Exclusion criteria included those with broken skin, foot ulceration,
lower limb amputation or a diagnosis of peripheral neuropathy. In-
dividuals with cognitive impairment (as determined by supervising
consultant) were also excluded from the study.
Sampling and recruitment
A sample size of 20 was identified as appropriate for the aims of
this pilot study (LoBiondo‐Wood & Haber, 2017). Qualitative
interviews were completed with 10 participants to elicit personal
experiences of the intervention and outcome measures and any
challenges or barriers. Patients were informed about the study
by posters displayed in the haemodialysis waiting area and by
SOLITUDE STUDY: REFLEXOLOGY AND HAEMODIALYSIS | 3

4. staff members working in the unit. Once patients expressed an
interest in taking part in the study, a member of the research
team along with the supervising consultant applied the inclusion/
exclusion criteria to ensure that the specified criteria were met.
All participants provided written informed consent.
Intervention
The reflexology intervention was delivered by a trained reflexologist
during the patient's regular haemodialysis session. This same reflexologist
carried out all the reflexology treatments. Privacy was maintained during
the delivery of the intervention using curtains, which were drawn around
the bed. Participants were offered a reflexology session three times a
week for 30 min over a 4‐week period. During the intervention, thumb
and finger pressure was applied to the reflex points of both feet. The
treatment sequence began with the right foot and progressed to the left
foot. The same firm but comfortable pressure was used throughout the
treatment with the same amount of time spent on each foot. The same
sequence and time were adhered to for each patient and for each sub-
sequent treatment. Grapeseed oil (5 ml) was used to carry out the
treatments. Grapeseed oil was chosen because it has a light nonsticky
consistency and provides a high slip for reflexology treatments. Grape-
seed oil is suitable for a wide variety of skin types and those with nut
allergies.
Data collection
Quantitative
At baseline, questionnaire data included patient characteristics of
age, gender, time on dialysis, marital status, ethnicity, employ-
ment, income, accommodation status, assessment of (HRQoL)
using the SF12 Health Survey questionnaire (Ware et al., 1996)
and patient quality of sleep using the Pittsburgh Sleep Quality
Index (PSQI) (Buysse et al., 1989). The SF12 includes physical and
health components and is scored such that a higher score is in-
dicative of a better quality of life, with scores ranging from 0 to
100. The PSQI is the most commonly used generic measure to
provide information on a respondent's sleep quality, discriminat-
ing “good” and “poor” sleepers whilst acknowledging the reliability
and validity of the tool. The scores range from 0 to 21, with lower
scores indicating better sleep quality. Participants were required
to complete the same questionnaires one month after the inter-
vention had been completed to compare baseline and post-
intervention responses.
Qualitative
Following the completion of the intervention semistructured inter-
views were completed with ten patients who had received the
intervention. These interviews were carried out by a research as-
sistant during the patient's haemodialysis session to explore their
perceptions and opinions of the reflexology intervention. A topic
guide was prepared covering a list of issues to be covered with each
participant. This flexible approach helped ensure the researcher
elicited the information required whilst giving participants the op-
portunity to elaborate on issues, which the researcher may not have
considered.
Data analysis
Quantitative
Data from the questionnaires were coded to attribute a numeric
value and were entered and analysed in IBM SPSS Statistics for
Windows, Version 22.0 (IBM Corp.). A range of descriptive sta-
tistics was used, including mean and standard deviation for con-
tinuous data, median and interquartile range for ordinal and
frequency and percentages for categorical data. To compare
changes in outcome measures and in the identification of mean
scores before and after the intervention, the paired samples t test
or the Wilcoxon signed ranks test was used. This analysis was
exploratory and assisted in identifying appropriate outcome
measures for a definitive trial, as opposed to evaluating impact
(Eldridge et al., 2016).
Qualitative
All interviews were transcribed verbatim. Thematic analysis was
used to analyse the interview data selected since it allows for a
systematic process that increases accuracy or sensitivity in un-
derstanding and interpreting observations about, for example,
people, events, and situations. The inductive approach to the-
matic analysis was used as coding, and theme development was
directed by the content of the data. In line with thematic analysis
guidance, codes were used to label the key concepts identified
from the data set, which were used to develop themes. NVivo
was used to manage the collected data due to its versatility in
assisting the management of many different types of qualitative
data (Parahoo, 2014).
Progression criteria
To determine the feasibility of a definitive trial of reflexology, we set the
following progression criteria: 80% of the target sample size (n = 20) was
recruited within a single haemodialysis centre. There was less than a 20%
attrition rate following baseline data collection. Acceptability of outcome
measures was reported according to completion rates and missing data,
with the acceptability of the reflexology intervention according to com-
pletion rates and qualitative data.
4 | MATTHEWS ET AL.

5. RESULTS
Recruitment and retention
All 24 patients who expressed interest provided informed consent.
However, only 20 participants received the intervention as 4 with-
drew before implementation. Reasons for ineligibility (after informed
consent had been given) included receiving a renal transplant (n = 3)
and sustaining a fractured ankle (n = 1) after providing informed
consent. This resulted in an attrition rate of 17%. The flow of par-
ticipants is presented in Figure 1, an adapted CONSORT flow dia-
gram from the CONSORT extension for reporting pilot and feasibility
studies (Schulz et al., 2010).
Demographics
The characteristics of the study participants are summarised in
Table 1. The mean age of participants availing of the reflexology
intervention was 72 years and 60% (n = 12) were male. Time on
haemodialysis ranged from less than 6 months to 10 years. Patients
attending all three haemodialysis sessions (morning, afternoon, and
evening) participated in the study (see Table 1). The ethnicity of
those who availed of the reflexology intervention was 100% White,
which is typical of the local population. Finally, 90% (18 out of the
20) who participated in the study were retired.
Feasibility of implementation
All sessions ran as planned, with each participant receiving reflex-
ology three times a week for 30 min over a 4‐week period (n = 12
sessions per patient). There was a 100% completion rate. The re-
flexology intervention was delivered by a trained reflexologist at the
patient's bedside approximately 10–15 min after their haemodialysis
treatment was initiated. It had no negative impact on the patient's
haemodialysis treatment, nor did it impinge on the routine of the
haemodialysis nurses or wider multidisciplinary team (MDT). No
adverse events were reported. The reflexology intervention did not
impact the haemodialysis procedure or functioning of the dialysis
machine. It was well received by all haemodialysis nurses and other
healthcare professionals working within the renal unit. Healthcare
professionals were positive about the reflexology intervention, given
the level of engagement and enthusiasm shown by the participating
patients. Privacy was maintained as the curtains were drawn.
Outcome measures
Acceptability
The data collection tools included the SF12 HRQoL and the PSQI. The
reliability and validity of both these tools have been widely published
(Ware et al., 1996) and (Buysse et al., 1989). Tools were completed with
ease at both time points, namely immediately before commencing and
1‐month postintervention. There were no missing data, and measures
were appropriate for capturing relevant outcome information.
TABLE 1 Summary of descriptive statistics of study sample
Variable Baseline (n = 20)
Age, years
Mean (SD) 71.65 (9.65)
Age categories (years), n (%)
41–50 1 (5%)
51–60 1 (5%)
61–70 6 (30%)
71–80 8 (40%)
81+ 4 (20%)
Gender, n (%)
Female 8 (40%)
Male 12 (60%)
Haemodialysis shift, n (%)
Morning 4 (20%)
Afternoon 7 (35%)
Evening 9 (45%)
Time on haemodialysis, n (%)
Less than 6 months 3 (15%)
6–12 months 2 (10%)
1–2 years 6 (30%)
2–3 years 4 (20%)
3–4 years 2 (10%)
4–5 years 2 (10%)
5–10 years 1 (5%)
Marital status, n (%)
Single/never married 6 (30%)
Married/common law 9 (45%)
Widowed 5 (25%)
Divorced –
Ethnicity, n (%)
White 20 (100%)
Black –
Other –
Accommodation status, n (%)
Live alone 8 (40%)
Live with family/spouse/friends 12 (60%)
Other –
Employment status, n (%)
Retired 18 (90%)
Unemployed, not seeking work 1 (5%)
Previously employed 1 (5%)
Income, n (%)
£5–10,000 9 (45%)
£11–20,000 9 (45%)
£21–40,000 1 (5%)
Declined to answer 1 (5%)
SOLITUDE STUDY: REFLEXOLOGY AND HAEMODIALYSIS | 5

6. FIGURE 1 CONSORT diagram outlining different phases of the pilot study
Qualitave
Themes
Theme1:
Benefits of
reflexology
Enjoyment/
Relaxaon and
stress reducon
Reducon in
symptoms and
improved sleep
Theme2:
Future reflexology
goals
Helping to reduce
the length of
dialysis
Openness to
improving life on
dialysis FIGURE 2 Themes emerging from
qualitative interviews
6 | MATTHEWS ET AL.

7. Quality of life
There was an increase in the mean scores examining the total, physical
health, and mental health components of the SF12 (see Table 2).
Comparison of the pre‐ and postintervention measure was conducted
using a paired samples t test. The assumption of the within‐pair dif-
ferences being drawn from a normal distribution held. The corre-
sponding p‐values are all statistically significant, indicating strong
evidence in a change of the SF12, pre‐ and postintervention, the phy-
sical health component having strong evidence for a change in the
outcome measure of improved health. The information included in
Table 2 suggests that the client's physical and mental health improved
following the reflexology intervention.
Quality of sleep
The mean total sleep score at baseline was 8.80 compared with 4.70,
following the reflexology intervention. A reduction in the mean total
sleep score signifies more positive changes in sleep quality. A paired
samples t test was again used since assumptions on the within‐pair dif-
ferences held. The mean difference was −4.1 (95% confidence interval
[CI] [−5.6‐2.6], p 0.001), thus providing compelling evidence that re-
flexology may have a positive effect on the sleep quality of patients
receiving haemodialysis (Unal Akpinar, 2016) and would be an ap-
propriate outcome measure to evaluate in a definitive trial.
Qualitative findings
We identified two central themes, which incorporated four sub-
themes in total (Figure 2). These are described below, with partici-
pant quotations used to demonstrate key points.
Theme 1: Benefits of reflexology
Enjoyment/relaxation and stress reduction
Most patients expressed general enjoyment when receiving re-
flexology, as one participant stated, “I thought it was very good. I
really enjoyed it” (P2). In addition, patients referred to a greater
sense of relaxation and recommended reflexology for patients on
dialysis; “Lovely, relaxing. You just lay back and closed your eyes
and took yourself whenever you wanted to be” (P7). Patients re-
ceiving haemodialysis can experience high levels of anxiety around
the treatment. However, participants stated that reflexology re-
duced this anxiety. One participant expressed his view thus, “It
just helped my mind to relax and my body to relax …for I was a bit
uptight at the time about dialysis. Since that I seem to have come
to accept it a bit better…It helped to take your mind of the actual
dialysis” (P5).
Reduction in symptoms and improved sleep
Patients reported a reduction in pain relating to their legs and feet as
a result of the reflexology intervention; “Well my legs felt better
after it, you know. My legs felt better” (P3). Improved sleep was
commonly regarded as a primary benefit from reflexology, with one
participant explaining “I actually felt it helped me get into a sleep
pattern better as well, which for me was a good thing. And from it
stopped I have fell back into old ways. So yes, I think it is one of the
best things I've have so far” (P4.)
Theme 2: Future reflexology goals
Future goals: Helping pass time on dialysis
For patients, who spend lengthy blocks of time on dialysis, the re-
flexology helped to pass the time more effectively. This was per-
ceived as a positive aspect of reflexology, as it ameliorated the
boredom most patients experience during haemodialysis: “Just you
come into have dialysis done and you are lying bored most of the
time. Whereas when you are getting the reflexology it was another
arrow to your bow, and you were able to relax more, I would say, for
definite” (P7). In addition, the duration of the reflexology interven-
tion was considered too short, and patients would have been happy
to participate in sessions for longer. As one participant explained, “It
seems a good length of time. But then it suddenly comes to a stop,
sort of thing” (P1).
Future goals: Openness and opportunities to improve life on dialysis
Patients expressed openness to try novel therapies, with one
participant stating clearly, “…I am all for complementary
TABLE 2 Outcome measures before and after the reflexology intervention
Initial score Final score
Quality of life and sleep quality tools Mean (SD) Mean (SD) Mean paired differences [95% CI] p Value
SF12 (PHC) 40.7 (26.9) 54.3 (27.0) 13.6 [7.3,19.9] 0.001
SF12 (MHC) 59.8 (22.5) 73.8 (19.4) 14.0 [4.0,24.1] 0.009
SF12 total 52.7 (22.0) 66.0 (19.0) 13.3 [5.3,21.2] 0.002
Pittsburgh Sleep Quality Index 8.80 4.70 −4.1 [−5.6,‐2.6] 0.001
Abbreviations: CI, confidence interval; MHC, mental health component; PHC, physical health component.
SOLITUDE STUDY: REFLEXOLOGY AND HAEMODIALYSIS | 7

8. therapies…” (P7). This openness was in part because of the per-
ception that interventions, such as reflexology, could improve life
while on dialysis.
…well whenever you are working you don't have time,
sort of thing. Then things come secondary. Whenever
you are not able to walk about as much as you used to,
you enjoy wee things like that a lot more (P1).
DISCUSSION
The present study was undertaken to examine the feasibility of de-
livering intradialytic reflexology for patients undergoing hospital‐
based haemodialysis. The study established that the intervention was
feasible and highly acceptable for patients. All feasibility progression
criteria were successfully met, as 100% of the target sample size was
recruited, and there was an attrition rate of less than 20%. This is
similar to recruitment rates for other pilot and feasibility studies of
intradialytic interventions (Thompson et al., 2016), suggesting that
the provision of interventions during haemodialysis treatment is a
highly acceptable mode of delivery. While there is some evidence
that people may be sceptical about the benefits of reflexology and
other complementary medicines and that this might have an impact
on the uptake of such interventions (Hmwe et al., 2020), this study
has established that there is enough interest and engagement to
support evaluation within a definitive trial.
The intervention did not interfere with clinical practice and
participants demonstrated high levels of adherence. The accept-
ability of the intervention was further reinforced by the qualitative
findings as patients reported that reflexology helped them relax,
reduced stress, improved their sleep and helped pass the time during
haemodialysis. However, it was suggested the reflexology interven-
tion could have been improved by increasing the length of the study
and providing more reflexology sessions.
Additionally, this study established that HRQoL, as measured by the
SF‐12 and sleep quality as measured by the PSQI, are appropriate out-
comes to be used in the definitive evaluation of this intradialytic reflex-
ology intervention. Many haemodialysis patients may be particularly
vulnerable to fatigue and sleep‐related problems. These symptoms are
often inadequately addressed due to the perception that poor sleep
quality is an inevitable part of kidney failure (Edley, 2020). Patients on
haemodialysis treatment find it difficult to fall asleep or stay asleep. They
experience a disturbed sleep pattern and complain of daytime sleepiness
(Agarwal Light, 2011). The causes of poor sleep quality can be multi-
factorial and include uraemia, restless leg syndrome and psychological
problems, such as depression and anxiety (Chu et al., 2018). The presence
of sleep disorders is associated with lower quality of life and higher
mortality in patients receiving haemodialysis therapy (Masoumi
et al., 2013). Although research indicates significant improvements in the
sleep quality of patients undergoing haemodialysis treatment using
nonpharmacological interventions, such as reflexology, no intervention
has improved the sleep quality of this cohort of patients to equate to that
of the general population (Edley, 2020). Given the significant impact and
association between reduced sleep quality, poor mental health and re-
duced HRQoL for patients undergoing haemodialysis therapy, this is an
area that cannot be underestimated. Although improvements were
measured in all outcome measures with regard to HRQoL and sleep
quality, it is important that the results from this current study are not
interpreted as demonstrating the efficacy of this intervention as this is a
non‐randomised pilot study (Eldridge et al., 2016). Instead, these results
imply the measures of HRQoL and sleep quality may be appropriate
clinical outcomes in a definitive trial.
IMPLICATIONS FOR CLINICAL PRACTICE
This nonrandomised pilot study demonstrated that it was possible to
recruit and retain participants to a trial of reflexology for patients
receiving haemodialysis. Implementation of the intervention was
highly acceptable to patients and healthcare professionals who were
asked for their views following completion of the intervention. This
study identified appropriate outcome measures for use within a
definitive trial, as significant improvements were shown in both the
physical and mental scores of the SF‐12 and sleep quality according
to the Pittsburgh Sleep Quality Index. Despite this high level of
feasibility and acceptability, additional considerations regarding
randomisation and longitudinal follow‐up should be made before a
definitive trial can take place. The findings of this study offer renal
units a greater awareness of the potential benefit of reflexology,
which, in turn, may encourage more health professionals to discuss
the use of these therapies with the patients under their care, thus
promoting the use of reflexology as nonpharmacological treatment in
addition to other conventional treatments and care.
LIMITATIONS
This study took place in a single haemodialysis unit with a homo-
geneous population. It is therefore difficult to determine whether
recruitment or attrition rates will differ in more heterogeneous popu-
lations. The exclusion criteria for the intervention included co‐morbid
conditions that are common amongst patients receiving haemodialysis,
including peripheral neuropathy and foot ulceration (Kaminski
et al., 2011), meaning that there may be a large proportion of the
population ineligible for participation. Adjustments to the intervention,
for example, by providing both foot and hand reflexology, could in-
crease the number of eligible participants and not exclude a large
proportion of the population. The inclusion of hand reflexology would
have enhanced this study, thus allowing exploration of an additional
mode of delivery and contributing further to the understanding of in-
tervention feasibility. As this study was a non‐randomised pilot study,
questions surrounding feasibility were limited by the lack of a control
group, randomisation and longitudinal follow‐up. The study was unable
to identify any issues surrounding randomisation procedures, con-
tamination of a control group or attrition over a longer period.
8 | MATTHEWS ET AL.

9. Consequently, there may be more preliminary work required to explore
other feasibility issues that might impact a randomised controlled trial.
However, the qualitative data demonstrated that the intervention was
highly acceptable, which could suggest that a waiting list control group
in a larger study may help attenuate the potential negative impact of
random allocation on the retention of participants.
CONCLUSION
It is possible to recruit and retain participants to a trial of reflexology
for patients receiving haemodialysis, and patients and healthcare
professionals are accepting of the intervention. Introducing reflex-
ology to patients with kidney disease may help people manage and
improve sleeping patterns, ultimately improving wellbeing.
ACKNOWLEDGEMENTS
The authors would like to thank the Northern Health and Social Care
Trust for providing the funding for this study, the Northern Ireland
Kidney Patient Association and the renal unit at Antrim Area Hos-
pital for their input and support throughout the study.
CONFLICT OF INTERESTS
The authors declare that there are no conflict of interests.
AUTHOR CONTRIBUTIONS
The final version of the manuscript has been read and approved by all
authors who agree to the submission of the manuscript to the Journal of
Renal Care. All authors contributed to the study conception and assisted
in the design of the study. Kim Murphy and Michael Matthews carried
out the literature review. Michael Matthews and Kim Murphy were
responsible for the qualitative data collection, Clare McKeaveney
was responsible for carrying out the qualitative interviews. Mi-
chael Matthews and Kim Murphy performed the data analysis in
collaboration with Helen McAneney. Claire Carswell and Michael
Matthews were responsible for drafting the final manuscript.
Helen Noble was responsible for the overall supervision of the
study and made critical revisions for important intellectual
content.
ORCID
Michael Matthews https://orcid.org/0000-0001-6635-0810
Claire Carswell https://orcid.org/0000-0003-3781-3286
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AUTHOR BIOGRAPHY
Michael Matthews completed his BSc in Health
Studies in Palliative Care (Queen's University,
Belfast). He graduated with a Diploma in Specia-
list Renal Nursing (Queen's University, Belfast),
completed a Post Graduate Certificate in Health
and Social Care in Diabetes (Ulster University),
and a Post Graduate Certificate in Professional Education
(Queen's University). He graduated with an MSc in Nursing
(Queen's University, Belfast). Most of Michael's experience has
been within the sphere of renal nursing, having held several
appointments including senior nurse, clinical research nurse and
practice educator. He is currently pursuing a PhD Course of
Study, having secured a scholarship from the Northern Ireland
Kidney Research Fund. His research interests include the needs
of informal caregivers of patients undergoing haemodialysis and
the development of supportive interventions.
How to cite this article: Matthews, M., Carswell, C.,
Redmond, A., Bolton, S., Murphy, K., Mullan, R. et al. (2021) A
nonrandomised pilot study to examine the feasibility and
acceptability of reflexology in patients undergoing
hospital‐based haemodialysis (solitude study). J Ren Care,
1–10. https://doi.org/10.1111/jorc.12372
10 | MATTHEWS ET AL.