Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

Reducing the Occurrence and Severity of Mucositis: Oral Comfort

Elecia Trowers
University of South Florida

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

Abstract
Clinical problem: A high number of patients undergoing chemotherapy suffer from oral
mucositis which causes an increase in the length of hospital stay, increased use of pain
medication and a decrease nutritional status (Svanberg, hrn, & Birgegrd, 2010).
Objective: To determine if the use of cryotherapy reduces the severity and incidence of mucositis
in patients undergoing chemotherapy. The search was completed using PubMed and CINAHL,
with the inclusion of key words; cryotherapy and mucositis; cryotherapy reduces mucositis and
cryotherapy therapy randomized trials.
Results: Heydari, Sharifi, & Salek (2008) showed that cryotherapy is a crucial step in reducing
the severity and the incidence of mucositis (p<0 .002). According to Katranci, Ovayolu,
Ovayolu, & Sevinc (2012) cryotherapy is effective in reducing the occurrence and severity of
mucositis in chemotherapy patients (p<0.05). Svanberg et al, (2010) cryotherapy in high dose
chemotherapy proves to be beneficial in reducing the frequency and severity of oral mucositis
and further increases nutrition (p<0.05).
Conclusion: The use of cryotherapy in patients undergoing chemotherapy was shown to be an
essential step in the reducing the occurrence and severity of oral mucositis, it has also shown to
further increase the nutritional outcome.

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

Reducing the Occurrence and Severity of Mucositis: Oral Comfort

Oral mucositis is the inflammation of the oral mucosa resulting from chemotherapy agents
(Svanberg et al., 2010). Oral mucositis is a problem in the facility because it affects many
patients and in some cases decreases nutritional status and increases hospital stay, which could
affect the rate of reimbursement for the hospital. The aim of the facility is to reduce healthcare
cost and improve patient outcome. There are numerous evidence based practices (EBPS) that are
aimed at reducing oral mucositis in chemotherapy patients, this paper will look at the use of
cryotherapy as an option. To aid in the reduction of oral mucositis the question of cryotherapy
use is proposed. In chemotherapy patients will oral care with cryotherapy, compared to no oral
care with cryotherapy impact the severity of, or prevent mucositis, within a 3 month span? The
infrastructure for the change, which includes the evidence based research team, oncology nurses
and doctors would be integrating the proposed initiative into the facilitys operation. The
implementation of cryotherapy requires minimal infrastructural and financial change. The facility
boasts a great oncology floor and has a EBP committee with profound interest in EBP.
Literature Search
The search engines used for the relevant literatures included CINAHL and PubMed. The
key terms used were; cryotherapy and mucositis, cryotherapy reduce mucositis, guideline for
mucositis and cryotherapy therapy randomized trials.
Literature Review
A sum of three randomized controlled trials along with one clinical guideline was
appraised in the use of cryotherapy to reduce the incidence and severity of oral mucositis in
patient receiving chemotherapy (Table1). Heydari, et al, (2010) performed a study which looked
at the effectiveness of cryotherapy in treating and preventing chemotherapy induced oral

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

mucositis. The analysis was done via a randomized controlled trial which entailed 80 cancer
patients. The patients all received an oral exam before undergoing chemotherapy and were then
divided into two groups; control which received no intervention and experimental which was
given cryotherapy ice chips in their mouths five minutes before chemotherapy. The study
measured the number of participants with an incidence of mucositis and also the severity. The
results of the study showed the control group having a higher incidence of oral mucositis (p =
0.01). The experimental group had 45% of the participants developing mucositis while the
control group had 75%. The study also showed a reduction in the severity of mucositis (p =
0.002). The outcome was measured by assessing the patients oral cavity over a number of weeks
for the presence of oral mucositis. Based on the findings of the trial cryotherapy is a crucial step
in preventing and reducing the severity of oral mucositis. It is also shown to be user friendly and
is highly tolerated.
The strengths of the trial entailed: randomized controlled trial and had participants from
similar demographics. The subjects were analyzed over a three week span and were assessed
using the World Health Organization (WHO) mucositis scale; this is a valid and reliable scale for
grading oral mucositis. The weaknesses are that the trial was not double blinded and some of the
results depended on the participants assessing and making daily recording of their own mucositis
status, which was not the most reliable because some participants did not make note of their
progress. In this study the strengths overpower the weaknesses and depict a valid study.
Katranci et al. (2012) executed a randomized controlled trial to evaluate the benefit of
oral cryotherapy in inhibiting oral mucositis, as it relates to the use of chemotherapy agents (5flourouracil and leucovorin). The study consisted of 60 participants; 30 patients from the
experimental group were instructed to hold cryotherapy ice cubes in the mouth a few minutes

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

before undergoing chemotherapy and 30 patients assigned the control group received standard
care. Observation for the presence of oral mucositis was conducted on day 7, 14 and 21 after
chemotherapy. The findings were that 60% of the intervention group and 23.3% of the control
had Grade 0 oral mucositis on day 7 and 14. Likewise the occurrence of grade 1, 2, and 3 oral
mucositis was lower in the interventional group (23%) than in the control group (26.6%). Grade
2 mucositis was significantly higher in the control group 36.6% and was only seen in 13.3% of
the interventional group. There were no notable difference in the control and experimental group
at day 21. Overall the interventional group had significantly less occurrence of mucositis
(p = < 0.05). The measures were assessed using the WHO mucositis scale; this is a valid and
reliable scale for grading oral mucositis. In conclusion cryotherapy was shown to be quite
effective in reducing the severity and occurrence of oral mucositis in chemotherapy patients.
The strengths of this trial are: randomized controlled trial and the participants were
similar in terms of their socio-demographics and individual characteristics. The weaknesses
were: the trial was not double blinded and not all the participant practice oral hygiene and were
already likely to develop oral mucositis, however the strengths outweighs the weaknesses and the
trial is considered a valid one.
Svanberg et al. (2010) performed a randomized controlled trial aimed at assessing the
effectiveness of oral cryotherapy in reducing severity and frequency of oral mucositis with
patients receiving chemotherapy. The trial further looked at the rate of infection and nutrition
status of the patients. The participants of the trial were above the age of 18. There were 78 total
participants, 39 assigned as the control which received routine care and 39 assigned as the
experimental which received cryotherapy treatment. results showed that there were notable fewer
patients in the experimental group with grade 3-4 oral mucositis than with the control group (p <

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

0.05). In conclusion the use of cryotherapy in high dose chemotherapy proves to be beneficial in
reducing the frequency and severity of oral mucositis and further increases nutrition.
The strengths of the trial were: it was a randomized controlled trial, the participants had
similar demographics and characteristics like smoking and age, the study also included nutrition
and infection rate, the outcome was measured using the WHO mucositis assessment scale; this is
a valid and reliable scale for grading oral mucositis. The weaknesses are: the trial was not double
blinded and three of the participants did not follow the care plan by using cryotherapy as
advised. Overall the strengths are greater than the weaknesses and hence the trial is considered
valid.
The guideline from Harris, Eilers, Harriman, Cashavelly, & Maxwell (2011) by the
Oncology Nursing Society gave information in regards to multiple EBPs used to aid in the
reduction of oral mucositis incidence and severity. Harris et al, (2011) recommends the use of
oral care protocols which includes proper oral hygiene and believes that the use of cryotherapy
will be valuable for patients who received bolus mucotoxic chemotherapy with a short half-life
(bolus 5-flourouracil melphalan), another recommendation included palifermin for patients who
receives transplants of hematopoietic stem cell.
Synthesis
Heydari et al. (2010) showed that cryotherapy is a crucial step in reducing the severity
and the incidence of mucositis (p< .002). According to Katranci al. (2012) cryotherapy is
effective in reducing the occurrence and severity of mucositis in patients receiving chemotherapy
agents (5-flourouracil and leucovorin) (p<0.05). According to Svanberg al. (2010) cryotherapy in
high dose chemotherapy proves to be valuable in reducing the frequency and severity of oral
mucositis and further increases nutrition (p<0.05).

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

Research shows that cryotherapy is effective in reducing the severity and incidence of
oral mucositis in chemotherapy patients, but according to Harris et al. (2011) cryotherapy is
contraindicated in certain chemotherapy agent for example oxaliplatin, it is said to result in
potential problems with cold exposure. It is also evident that patient who does not tolerate cold in
their oral cavity will not be able to tolerate cryotherapy; therefore it should not be administered
in those patients. The studies varied in terms of the when cryotherapy is administered; from three
to five minutes before the administration of chemotherapy. The gaps in the study came with the
patients who continued to monitor for mucositis at home, not all patient will keep good oral
hygiene and follow the treatment protocol.
Proposed Practice change
Harris el al, affirms that the use of cryotherapy in patients receiving certain chemotherapy
regimen decreases the frequency and seriousness of oral mucositis. Hence cryotherapy should be
among the treatment of choice for this facility. The guideline requires small ice cubes to be given
at least three minute before the initiation of chemotherapy, the patient will be asked to slowly
move the ice chip around in the mouth until it melts. Ice chips will be replenished until the
initiation of chemotherapy, care will be taken to ensure the ice chips cause no irritation to the
oral mucosa. The patient will continue with ice chips for up to fifteen minutes after
chemotherapy. Cryotherapy along with education for use should be available to the providers.
The target population for this change should include oncology and bone morrow transplant
patient who are being treated with melphalan, (5-flourouracil and leucovorin) or high dose
chemotherapy agents. The exclusion for this change should be patients who have head or neck
malignancies and are unable to drink or eat. Patients who are physically or developmentally
challenged should be excluded if they are not able to perform the intervention. The practice

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

should implement and follow the guidelines of the presented evidence in order to change and
become evidence based.
Change Strategy
There are many ways to go about putting a new change into practice but, this route might
prove more effective; implement an EBP course or presentation to include all parties necessary to
making the change a success and allow staff and stakeholders to voice their concerns on how the
change will affect their productivity and or patient outcomes. Staff should also be encourage to
share their recommendations with stakeholders, and the creation of EBP mentorship programs
could help in assessing the effectiveness of staff in the implementation of the new change. Team
members should be allowed to provide their recommendation to all stakeholders, who should
include; all administrative leaders and who will make and approve the decision of accepting the
practice as standard care (Melnyk & Fineout- Overholt, 2011). The Rosswurm and Larrabee model
of evidence practice will be used to guide the implementation of the practice change.

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

Roll Out Plan

STEPS
Step 1

Definition
Analyze the necessity for modification in practice
Include stakeholders (Administrative
staff, Doctors)
Gather inside data about present practice
(Look at what is currently being done)
Compare inside and outside data.
(Compare available data)
Recognize problems, interventions, and
outcomes. (Be able to identify the present
problems and the necessary action to fix
problems.

Timeframe For Rollout

Concluded January 2015

Step 2

Find the best evidence

Determine types and sources (Understand
the sources needed to aid in finding
evidence)
Assess research concepts
Plan the search (Have ideas of where to
look for the information desired)
Conduct the search (Navigate the
resources)
Critically evaluate the evidence
Analyze and weigh the evidence (Look at
the evidence in-depthly)
Synthesize the best evidence (Pull out the
most effective evidence)
Assess feasibility, benefits, and risks of
new practice (Appraise the benefit of the
evidence and weight the risk)
Design practice change
Interpret proposed change (break down
and explain the change)
Identify needed resources (Recognize the
necessary resources needed)
Design the analysis of the pilot (Draft
analysis of the sample plan)
Design the implementation plan (Create
the plan intended for implementation)
Implement and evaluate change in practice
Implement pilot study (Put the proposed

Concluded February 2015

Step 3

Step 4

Step

Concluded March 2015

April 2015

Implement May 2015

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

10

plan in place)
Analysis August 2015
Analyze processes, outcomes, and cost
(Look at the cost and processes involved)
Develop conclusions and
recommendations (summarize evaluation
and make recommendations)
Step 6
Integrate and maintain change in practice
November 2015
Communicate recommended change to
stakeholders ( Meet with stakeholder and
divulge information about recommended
change)
Integrate into standards of practice.
Monitor process and outcome periodically
Celebrate and disseminate results of
project.
Model of evidence based practice change ((Melnyk & Fineout-Overholt, 2011, p. 255).
Project Evaluation
As of May all patients receiving indicated chemotherapy agents will follow the guideline
that requires small ice cubes to be given at least three minute before the initiation of
chemotherapy, the patient will be asked to slowly move the ice chip around in the mouth until it
melts. Ice chips will be replenished until the initiation of chemotherapy, care will be taken to
ensure the ice chips cause no irritation to the oral mucosa. The patients will be assessed for the
presence of oral mucositis for up to three weeks after chemotherapy. If the patient has an incident
of oral mucositis further assessment will be made to determine the severity. All recipients will be
assessed, and the number of incidents will be recorded along with the severity grade. The results
will then be compared to past results within the same time period and an analysis made to
determine the success rate. If less than 35% of the patients presents with oral mucositis and the
severity grade is less than past result then this could be considered a success.

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

11

Dissemination of EBP
To promote adoption of the implemented practice, dissemination will be done via
conferences, professional presentation and publications such as; PowerPoint presentation,
emailed newsletters, and pre- recorded conferences. This will remind staff and stakeholders of
the guidelines for practice, the progress of the new practice, and the importance of improvement
in EBP. This could promote a culture of learning and encourage a best evidence practice
environment. The practice could be disseminated to other areas of the facility with the use of
EBP committee which shares current and ongoing practices with the other departments of the
facility which could utilize such practice. The use hard copy newsletters and posters along with
publication of the practice could be used to disseminate the practice regionally (Melnyk &
Fineout-Overholt, 2011).

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

12

Reference
Heydari, A., Sharifi, H., & Salek, R. (2012). Effect of oral cryotherapy on combination
chemotherapy-induced oral mucositis: A randomized clinical trial. Middle East Journal
of Cancer, 3(2), 55-64.
Katranci, N., Ovayolu, N., Ovayolu, O., & Sevinc, A. (2012). Evaluation of the effect of
cryotherapy in preventing oral mucositis associated with chemotherapy A randomized
controlled trial. European Journal of Oncology Nursing, 16(4), 339-344.
doi:10.1016/j.ejon.2011.07.008
Melnyk, B. M., & Fineout-Overholt, E. (2011). Evidence-based practice in nursing & healthcare: A
guide to best practice (2nd ed.). Philadelphia, PA: Wolters Kluwer Lippincott Williams &
Williams.

Harris DJ, Eilers J, Harriman A, Cashavelly BJ, Maxwell C. (2008, February 01). Evidence-based
intervention for the management of oral mucositis. Agency for healthcare research and
quality. Retrieved March 21, 2015, from http://www.guideline.gov/content.aspx?
id=15700&search=cryotherapy

Svanberg, A., hrn, K., & Birgegrd, G. (2010). Oral cryotherapy reduces mucositis and
improves nutrition -- a randomised controlled trial. Journal of Clinical Nursing, 19(1516), 2146-2151. doi:10.1111/j.1365-2702.2010.03255.x

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

13

Table 1
Literature Table
Reference

Aims

Designs and
Measures

Heydari, A.,
Sharifi, H., &
Salek, R. (2012).
Effect of oral
cryotherapy on
combination
chemotherapyinduced oral
mucositis: A
randomized
clinical trial.
Middle East
Journal of
Cancer, 3(2), 5564.

The purpose of
this trial was to
look at the
benefit of
cryotherapy in
treating and
preventing
chemotherapy
related oral
mucositis.

Randomized
controlled trial.

Katranci, N.,
Ovayolu, N.,
Ovayolu, O., &
Sevinc, A. (2012).
Evaluation of the
effect of
cryotherapy in
preventing oral
mucositis
associated with
chemotherapy A
randomized
controlled trial.
European Journal
of Oncology
Nursing, 16(4),
339-344.
doi:10.1016/j.ejon
.2011.07.008

The aim of the

trial was to look
at the benefit of
cryotherapy in
preventing oral
mucositis, as it
relates to the
use of
chemotherapy
agents (5flourouracil and
leucovorin).

Randomized
controlled trial.

Measures: The
study measured
the number of
participants with
an incidence of
mucositis and
also the severity.

Measures: The
measures were
assessed using
WHO mucositis
scale, which
graded the
severity of oral
mucositis.

Samples

Outcome/

Statistics
The study entailed
Based on the
80 cancer patient
finding of the
divided into two
trial
groups; control
cryotherapy is
which received no
said to be a
intervention and
crucial step in
experimental which preventing
was given
and reducing
cryotherapy ice
the severity of
chips in their mouths oral mucositis,
five minutes before
it is also easy
chemotherapy.
to use and
highly
tolerated.
The study consisted
of 60 participants,
30 patients from the
experimental group
was instructed to
hold cryotherapy ice
cubes in the mouth a
few minutes before
undergoing
chemotherapy and
30 patient assigned
the control group
received routine
care.

Cryotherapy
was shown to
be quite
effective in
reducing the
severity and
occurrence of
oral mucositis
in
chemotherapy
patients.

Running head: ORAL COMFORT: REDUCING ORAL MUCOSITIS

Svanberg, A.,
hrn, K., &
Birgegrd, G.
(2010). Oral
cryotherapy
reduces mucositis
and improves
nutrition -- a
randomized
controlled trial.
Journal of
Clinical Nursing,
19(15-16), 21462151.
doi:10.1111/j.136
52702.2010.03255.
x

The goal of this

study was to
assess the
benefits of oral
cryotherapy in
reducing
seriousness and
frequency of
oral mucositis
in patients
receiving
chemotherapy.

Randomized
controlled trial
Measures: The
measures were
assessed using
WHO mucositis
scale, which
graded the
severity of oral
mucositis.

The participants of
the trial were above
the age of 18, there
were 78 total
participants, 39
assigned as the
control which
received routine care
and 39 assigned as
the experimental
which received
cryotherapy
treatment.

14
The use of
cryotherapy in
high dose
chemotherapy
proves to be
beneficial in
reducing the
frequency and
severity of
oral mucositis
and further
increases
nutrition.