Keywords Low/middle-income countries - pediatric oncology - preprocedural preparation - procedural
pain
Introduction
Globally, the incidence of childhood cancer is estimated to be around 165,000 new
cases annually, of which 80% occur in low- and middle-income countries (LMIC).[1 ]
[2 ] All cancer patients experience pain at some point in the trajectory of their disease,
which most often can be described as tumor-related pain due to the tumor’s invasive
growth or treatment-related pain due to procedures or to side effects to the given
therapy. According to the International Association for the Study of Pain, pain is
defined as “An unpleasant sensory and emotional experience associated with actual
or potential tissue damage, or described in terms of such damage. Pain is always subjective.
Each individual learns the application of the word through experiences related to
injury in early life.”[3 ]
Pain assessment in children
The various tools used for pain assessment in pediatric patients focus mainly on quantifying
pain intensity and are roughly dividable into self-report tools and behavioral and
physiological pain assessment tools. Due to the subjective nature of pain, self-report
is considered to be the golden standard and should thus be used whenever it is possible.
The most widely used self-report tools, validated for pediatric patients, are as follows:
the Numeric Rating Scale (NRS), the Visual Analog Scale, the Faces Pain Scale (FPS),
the FPS-Revised (FPS-R), the Wong-Baker Faces Pain Rating Scale (WBFPRS), and the
Oucher Pain Scale. In general, pain levels over 3 on a 0–10 pain scale are considered
to require a pain-relieving intervention.[4 ]
[5 ]
Like pain, fear is subjective and the golden standard in fear assessment is thus self-report.
The Children’s Fear Scale (CFS) is a self-report faces scale composed of five faces
ranging from no fear (0) to maximal fear (4). CFS is validated for use in patients
over 5 years of age.[6 ]
Procedural pain in childhood cancer patients
Procedural pain caused by blood sampling, lumbar puncture (LP), bone marrow (BM) aspirations,
biopsies, and other procedures required for the diagnosis and treatment of cancer
is a major part of the treatment-related pain in childhood cancer patients (the still-developing
nervous system in a child, together with the psychological immaturity with fewer and
less developed coping strategies, makes children especially sensitive to pain and
to its consequences).[7 ] Procedural pain is influenced by expectations and earlier experiences of pain, as
well as affective and emotional components, such as fear that is known to increase
the perception of pain.[8 ]
[9 ]
[10 ]
[11 ]
[12 ]
[13 ]
[14 ]
There are different pharmacological as well as nonpharmacological methods to mitigate
pain and fear during medical procedures.[12 ]
[13 ] Guidelines for procedural pain management in children recommend age-adequate information
and preparation as the first intervention.[14 ]
[15 ] Together with topical anesthetics, preparation is regarded to be basic in pain management
and recommended for all patients before procedures. Inappropriate management of procedural
pain in children has been found to be associated with increased pain and anxiety in
subsequent painful procedures [7 ]
[13 ]
[16 ]
[17 ]
[18 ] as well as increased pain sensitivity in adulthood.[7 ]
[10 ]
[19 ]
In pediatric oncology care in high-income countries, general anesthesia is the standard
practice for providing sedation and analgesia during medical procedures such as BM
aspirations and LPs. According to a survey of pediatric cancer hospitals in India,
published in 2010, general anesthesia was not used anywhere in the country for BMs
or LPs.[20 ]
[21 ] In 89% of the centers, some type of sedation or analgesia was used in LPs. In the
majority of the surveyed centers, systemic sedation and analgesia using ketamine or
midazolam were used, but at some centers, only local anesthetics were the standard
of care. The authors describe lack of resources as a probable cause of this, as the
use of systemic sedation and analgesia was considerably higher in private or cooperative
hospitals compared to state-financed public hospitals.
Aim
The aim of this study was to evaluate the prevalence of and quantify the intensity
of procedural pain and fear experienced by the pediatric cancer patients undergoing
a LP and to assess the feasibility of a preprocedural preparation and its impact both
on the comprehension of the procedure and on the level of pain. The secondary objective
of this study was to compare the patients’ self-reported pain with the pain assessments
done by closest caregivers and by the medical staff performing the procedures.
Methods
This state-financed hospital is the only cancer hospital providing oncological treatment
free of charge for patients below the poverty line in a catchment area of 85 million
inhabitants in the states of Telangana and Andhra Pradesh. Medical, surgical, and
radiation therapy is available, as is a specialized palliative care unit. There is
a specialized pediatric oncology department with approximately 90 beds in two wards.
The hospital has around 350 beds for in-house patients and a shelter for outpatients
during treatment.
This study was a prospective interventional trial. First, a preparatory material for
information about the LP procedure was put together specifically for this study, for
this underprivileged group of patients in a low-resource hospital. This preparatory
material included basic information on the anatomy of the spine, the spinal cord,
and the spinal fluid and why and how a LP is performed. This material was presented
to the patients and caregivers in Group B, during the second half of the study period.
During the first study-period, LP: S were performed, according to routines at the
hospital, without informational preparation, Group A. Data concerning levels of pain,
fear, and understanding of the procedure were collected for comparison between the
two groups of patients. Data on pain reports from the child, the caregiver, and the
performing medical staff were also compared.
Inclusion and exclusion criteria
All patients between 5 and 18 years of age, admitted to the hospital and undergoing
LP during the data collection period, were asked for participation in the study. Children
unable of self-reporting and children, who for some reason were not interviewed on
the same day as they had the procedure, were excluded. Patients who underwent LP multiple
times during the study period were only included once.
Data collection
The data collection period extended from February 25, 2017, to April 12, 2017. Sociodemographic
data such as age, sex, education, and occupation were obtained through interviews
with the family. The diagnosis and date of the first admission to the tertiary cancer
hospital were obtained from handwritten medical records. As data on the number of
previous LPs were frequently incomplete in the patients’ medical records, this information
was asked for in the interviews with the family.
Patients were sequentially selected for the intervention with preprocedural preparation
or not. Between February 25, and March 9, data were collected by interviewing patients
who did not receive any information or preparation before the LP, henceforth referred
as patients in Group A. The preparatory interventions and the data collection from
the patients who received preparation, Group B, started on March 10 and continued
until April 12. However, some patients who went through a LP during this latter period
missed out from the preprocedural preparation and were thus included in the nonintervention
group, Group A.
Preprocedural preparation
For the purpose of this study, a film was recorded to serve as a preprocedural information
for pediatric patients before their LP [Appendix 1]. The video was recorded in the
local language Telugu and consisted of a 5-min long explanation about the anatomy
of the spine, why the LP is performed and showing the procedure, on a teddy bear,
and also demonstration a LP done in a pediatric patient at the hospital.
Questionnaire
Questions [Appendix 2] to map the procedural pain, fear during the procedure, knowledge
of why the LP was done, and the cause for the LP (diagnosis) were phrased in an interview
form. Patients, closest caregiver, and performing doctor were all asked for pain and
fear levels; patients and caregivers were asked for knowledge of the LP and diagnosis
for which a LP was done. The questionnaire was read out to all patients, caregivers,
and doctors. It required 5–10 min to complete. The questions to the staff were asked
in English immediately after each procedure. The questions to the patients and their
caregivers were asked in the local language after returning to the ward from the procedure
room. The goal was to interview each patient within 1 h from the procedure, and the
time between procedure and interview was registered for each case.
Pain
The level of pain was assessed by a scale which was a combination of WBFPRS, NRS,
and Colored Analog Scale, as this pain assessment tool was already in clinical routine
at the pediatric ward at the hospital [Figure 1 ].
Figure 1: The pain scale used for procedural pain assessment
Fear
Fear during procedure was assessed with the CFS [Figure 2 ], and patients, caregivers, and doctors were all asked to grade the level of fear.
Figure 2: Children’s Fear Scale used for fear assessment
Reason for the procedure
In question number 3, the patient and the caregiver were asked whether they knew why
the procedure was done. The obtained answers were classified as either “yes” or “no.”
Any answer stating that the purpose of the procedure was to treat or reduce the symptoms
or the burden of the disease was classified as a “yes.”
Diagnosis
In question number 4, the patient and the caregiver were asked whether they were familiar
with which disease the patient suffered from. Any answer stating that the disease
was a form of cancer was classified as a “yes.”
Ethical approval
Ethical approval for the study was granted by the ethical committee at hospital. Participation
in the study was voluntary. Oral and written information about the study was supplied
to all the patients and their caregivers, and written consent for participation was
obtained from each caregiver by collecting a signature or a thumb imprint, if illiterate.
The participants could at any point withdraw from the study without any consequences.
Statistical analysis
Before the data collection, a statistical power calculation was carried out. We assumed
the true mean difference in NRS score between children having intervention and children
not having intervention to be 3 units and the pooled standard deviation to be 6. Using
these assumptions, a total number of 128 patients were needed to be able to reject
the null hypothesis that the group means are equal with 80% power. Probability of
Type I error (alpha) associated with this test was 5%. The true mean difference in
NRS score between children and parents, as well as between children and doctors, was
assumed to be 2.5 units, the standard deviation to be 6, and the correlation between
the groups to be 0.4. Using these assumptions, a total number of 57 pairs (patient
and parent, patient and doctor) were needed to be able to reject the null hypothesis
that the true mean difference is 0 with 80% power. Probability of Type I error (alpha)
associated with this test was 5%.
The statistical calculations were carried out in Excel 2010 and in SAS Enterprise
Guide, version 6.1. As the obtained data were not symmetrically distributed and the
study groups were relatively small, the median was used as the measure of central
tendency. As the NRS is an ordinal scale that consists of a limited number of values,
the Mann–Whitney U-test was used to investigate if there were differences between
Group A and Group B. For the binomial data (knowledge of diagnosis and understanding
of the reason for the procedure), Fisher’s exact test was used to investigate if there
were differences between the two study groups. Since the comparison between children
and caregivers, as well as children and health-care personnel, consisted of paired
samples, Wilcoxon signed-rank test was used to investigate if there were differences
between the pain scores within the pairs. P = 0.05 was considered statistically significant.
Results
In total, 79 patients met the inclusion criteria for this study and were asked for
participation. Caregivers to all patients gave their consent to participate. Three
patients were later excluded because they were not interviewed on the day of the procedure
or were unable of providing a self-report [Figure 3 ]. Group A consists of 51 patients who underwent LP without preparation and Group
B consists of 25 patients who underwent the preparatory intervention before the LP.
The study was limited by time constraints, and we did not reach the planned inclusion
of 128 children.
Figure 3: Flowchart of participants
Baseline data
Sociodemographic data such as age, gender, religion, educational level, family income,
caregiver’s educational level, and caregiver’s occupation were similar between the
two study groups [Table 1 ]. The distribution of diagnoses within the two groups, see [Table 1 ].
Table 1
Sociodemographic and other baseline data in the two study groups
Group A (no intervention)
Group B (preparation)
ALL - Acute lymphoblastic; AML - Acute myeloid leukemia; APML - Acute promyelocytic
leukemia; INR - Indian Rupee; USD - United States Dollar
Sample size
51
25
Sex
Female=19 (37%), male=32 (63%)
Female=11 (44%), male=14 (56%)
Age, median (minimum-maximum) years
10 (5-18)
9 (5-16)
Diagnosis (%)
ALL
48 (94)
18(72)
AML (included APML)
1 (2)
5 (20)
Other
2 (4)
2 (8)
Age adequate education
48 (94)
25 (100)
Religion
Christian
7 (14%)
2 (8%)
Hindu
34 (67%)
18 (72%)
Muslim
10 (20%)
5 (20%)
Urban or rural
U=17 (33%) R=34 (67%)
U=7 (28%) R=18 (72%)
Relation of primary caregiver
Mother
39 (76)
12 (48)
Father
9 (18)
12 (48)
Other
3 (6)
1 (4)
Caregiver education
No education
23 (45)
10 (40)
1-10 years of school
11 (22)
7 (28)
10-12 years of school
14 (27)
5 (20)
Higher education
3 (6)
3 (12)
Caregiver occupation
Agriculture
7 (14)
4 (16)
Daily labor
24 (47)
13(52)
Housewife
14 (27)
4 (16)
Other
6 (12)
4 (16)
Mean monthly family income (%)
<5000 INR (≈77 USD)
13 (25)
8 (32)
5000-10 000 INR (≈77-155 USD)
36 (71)
16 (64)
>10,000 INR (≈155 USD)
2 (4)
1 (4)
Family type (nuclear or joint)
N=44 (86) J=7 (14)
N=19 (76) J=6 (24)
The ages of the patients ranged between 5 and 18 years with a median of 10 (5–18)
years in Group A and 9 (5–16) years in Group B. The majority of the patients attended
school and lived in nuclear families in a rural setting. The attending caregiver was
the mother in 67% of the cases, almost half of the caregivers were illiterate, and
most caregivers had occupations within daily labor. The majority of the patients had
been diagnosed with acute lymphoblastic leukemia and the second most common diagnosis
was acute myeloid leukemia. The few remaining patients had the diagnoses of Burkitt’s
lymphoma, anaplastic large cell lymphoma, and Ewing sarcoma. Out of the 79 patients,
only 14 patients underwent the LP for the first time, and the median number of previous
LP in the remaining 64 patients was 4 (0–40). For one patient, data were not found
regarding previous LP, and for two patients, the number of previous LP was not known.
Interviews
The majority of the interviews were conducted by the same interpreter. However, in
total, four different interpreters were involved in the data collection. Two patients
and their caregivers did not speak the local language but spoke English and were therefore
interviewed in English by the author. In Group A, the median time between procedure
and interview was 40 (5–225) min. In Group B, the median time between procedure and
interview was 25 (5–190) min.
Preprocedural preparation
In Group B, the informational video was shown to the children together with their
caregivers on the day of the procedure, about 1 h before the procedure. A nurse or
a social worker gathered the patients and their caregivers as a group, from 1 to 11
patients with caregivers on each occasion, in a separate room and showed the video
on a laptop. Afterward, there was time for questions and discussion. The total duration
of the preparation was around 15 min and most often four to five patients with caregivers
participated.
Topical anesthesia
Before the LP, topical anesthesia (lidocaine and prilocaine cream) was applied to
most, but not to all patients included in this study. In Group A, 8/51 (16%) and,
in Group B, 1/25 (4%) of the patients did not receive topical anesthesia. The time
of application was not registered but is estimated to be 5–45 min before the procedure.
Pain
The median pain score of the patients was 4.0 (0–10) in Group A and 3.0 (0–8) in Group
B, with a significant difference between the groups (P = 0.022). The median pain score estimated by the caregivers was 4.0 (0–10) in Group
A and 2.0 (0–10) in Group B, with a significant difference between the groups (P = 0.0090). The median pain score estimated by the doctors performing the LPs was
2.0 (0–6) in Group A and 2.0 (0–7) in Group B, with no significant difference between
the groups (P = 0.6875) [Table 2 ] and [Figure 4 ].
Table 2
Comparison of pain scores and fear scores reported by patients, caregivers, and staff
in the two study groups
Variable
Responder
Group A (no intervention)
Group B (preparation)
a Mann-Whitney U-test. SD - Standard deviation; IQR - Interquartile range (Q3-Q1)
Pain
Patient
score
n (missing)
51 (0)
25 (0)
(0-10)
Mean (SD)
4.3 (2.2)
3.3 (1.9)
Median (IQR)
4.0 (2.0)
3.0 (2.0)
Q1; Q3
3; 5
2; 4
Minimum; maximum
0; 10
0; 8
P
a
0.0217
Caregiver
n (missing)
46 (5)
24 (1)
Mean (SD)
4.4 (2.4)
3.0 (2.0)
Median (IQR)
4.0 (4.0)
2.0 (1.0)
Q1; Q3
2; 6
2; 3
Minimum; maximum
0; 10
0; 10
P
a
0.0090
Staff
n (missing)
51 (0)
25 (0)
Mean (SD)
2.2 (1.7)
2.4 (1.8)
Median (IQR)
2.0 (2.0)
2.0 (2.0)
Q1; Q3
1; 3
1; 3
Minimum; maximum
0; 6
0; 7
P a
0.6875
Fear
Patient
score
n (missing)
51 (0)
25 (0)
(0-4)
Mean (SD)
1.8 (1.1)
1.7 (1.0)
Median (IQR)
2.0 (1.0)
1.0 (1.0)
Q1; Q3
1; 2
1; 2
Minimum; maximum
0; 4
0; 4
P
a
0.7681
Caregiver
n (missing)
46 (5)
24 (1)
Mean (SD)
1.8 (1.1)
1.8 (1.0)
Median (IQR)
2.0 (1.0)
1.5 (1.0)
Q1; Q3
1; 2
1; 2
Minimum; maximum
0; 4
1; 4
P
a
0.7597
Staff
n (missing)
49 (2)
25 (0)
Mean (SD)
1.7 (1.3)
1.8 (1.3)
Median (IQR)
1.0 (2.0)
1.0 (2.0)
Q1; Q3
1; 3
1; 3
Minimum; maximum
0; 4
0; 4
P
a
0.8228
Figure 4: Pain scores for procedural pain experienced during a lumbar puncture, reported
by patients, caregivers, and staff in Group A (no intervention) and Group B (preparation)
The median difference between each child’s self-reported pain score and its caregiver’s
estimated pain score (i.e., the caregiver’s score minus the child’s score) was 0.0
((-5)4), with no difference between the pain scores (P = 0.9828). The median difference between each child’s self-reported pain score and
the pain score estimated by the doctor who performed the LP on that child (i.e., the
doctor’s score minus the child’s score) was 2.0 ((-4)7), with a significant difference
between the pain scores (P < 0.0001), evidently an underestimation of the child’s pain [Table 3 ].
Table 3
Differences between paired pain and fear scores reported after the lumbar punctures.
The difference is given by each observer’s pain score minus each respective patient’s
pain score
Variable
Patient versus caregiver
Patient versus staff
a Wilcoxon signed-rank test. SD - Standard deviation; IQR - Interquartile range (Q3-Q1)
Pain score (0-10)
n (missing)
70 (6)
76 (0)
Mean (SD)
0.0 (2.0)
1.7(2.3)
Median (IQR)
0.0 (3.0)
2.0 (3.0)
Q1; Q3
-2; 1
0; 3
Minimum; maximum
-5; 4
-4; 7
P
a
0.9828
<0.0001
Fear score (0-4)
n (missing)
70 (6)
74 (2)
Mean (SD)
0.0 (0.9)
0.0 (1.5)
Median (IQR)
0.0 (1.0)
0.0 (2.0)
Q1; Q3
-1; 0
-1; 1
Minimum; maximum
-3; 4
-3; 4
P
a
0.6744
0.9069
Fear
The median fear score of the patients was 2.0 (0–4) in Group A and 1.0 (0–4) in Group
B, with no significant difference between the groups (P = 0.7681). The median fear score estimated by the caregivers was 2.0 (0–4) in Group
A and 1.5 (0–4) in Group B, with no significant difference between the groups (P = 0.7597). The median fear score estimated by the doctors performing the LPs was
1.0 (0–4) in Group A and 1.0 (0–4) in Group B, with no difference between the groups
(P > 0.8228) [Table 2 ]. Furthermore, comparisons of fear scores reported by the patients, their caregivers,
and the doctors showed no significant differences between the self-report and the
estimations [Table 3 ].
Reason for the procedure
In Group A, 7/51 (14%) of the patients knew why the procedure was done, as compared
to 11/25 (44%) of the patients in Group B, with a significant difference between the
groups (P = 0.0081). In Group A, 19/51 (37%) of the caregivers knew why the procedure was done,
as compared to 22/25 (88%) of the caregivers in Group B, with a significant difference
between the groups (P < 0.0001) [Figure 5 ].
Figure 5: Understanding of the procedure among the study participants in Group A (no
intervention) and Group B (preparation). Percentage of patients and caregivers who
knew why the lumbar puncture was done
Diagnosis
In Group A, 14/51 (27%) of the patients knew that they had cancer, as compared to
10/25 (40%) of the patients in Group B, with no significant difference between the
groups (P > 0.3). In Group A, 48/51 (94%) of the caregivers knew that the patient had cancer,
as compared to 25/25 (100%) of the caregivers in Group B, with no significant difference
between the groups (P > 0.3) [Figure 6 ].
Figure 6: Knowledge of diagnosis among the study participants in Group A (no intervention)
and Group B (preparation). Percentage of patients and caregivers who knew that the
patient had cancer
Discussion
In the present study, we have shown that it is possible to develop comprehensible
information material for preprocedural preparation in a low-resource setting and the
feasibility to perform group preparation before a painful medical procedure with families
with poor socioeconomic background and low educational level in a LMIC. We found that
this preparation led to significantly lower self-reported pain ratings among pediatric
cancer patients undergoing a LP (P = 0.022).
Furthermore, we found that the understanding of why the procedure was done increased
significantly among both the patients and their caregivers following this preparatory
intervention. The preparation contained no information about cancer, and there was
no significant difference in knowledge of the diagnosis among the patients and the
caregivers in the two study groups. This further supports our conclusion that the
difference in understanding the reason for the LP procedure was a consequence of the
preparatory intervention and not of prerequisite differences in the level of knowledge
between the two study groups.
Our finding that doctors who performed the LPs underestimated the procedural pain
experienced by their patients (P < 0.0001), which is in line with the findings of many other researchers depicting
that i.e medical personnel’s underestimation of children’s pain, and that is a common
reason for the under-treatment of pain in pediatric patients.[12 ]
[15 ]
There are multiple other studies that suggest that preparation before medical procedures
or surgery can help to reduce anxiety in pediatric patients and their parents and
increase their understanding of the procedure.[22 ]
[23 ]
[24 ]
[25 ]
[26 ] However, the results of these studies are often not statistically significant. Moreover,
many of these publications study combinations of different nonpharmacological interventions,
making it difficult to draw conclusions specifically about preprocedural information.
Two review articles that aim to summarize the current state of knowledge about preprocedural
preparation in childhood patients describe that the quality of evidence for preparatory
information is low, but that the recommendation for such interventions is nevertheless
strong.[12 ]
[13 ] In the present study, with 76 children included, the results are significant and
we postulate that the significance would increase had we included more patients.
There are several sources of potential bias to this result, which need to be discussed.
In our study sample, variations in the use of topical anesthesia were observed, as
well as variations in the number of previous LP procedures that each patient had already
experienced. Both of these factors can be assumed to influence a patient’s experience
of pain and fear from the procedure included in our analysis. On the other hand, the
administration of the only analgesic, i.e. the topical formula, was not provided in
a timely correct manner, as the anesthetic effect is evident first after around 1
h, and the time between application and the procedure in this study was estimated
to be 5-45 min.
We chose to conduct the interviews with the pain scale that was in use at the hospital
and familiar to both the staff and many of the patients, a WBFPRS with some additional
features, despite the limitations associated with the use of a nonvalidated combination
of multiple pain scales, as well as the emotional appearances of the faces in the
WBFPRS. Pain assessment in children is a challenge in clinical practice. In the youngest
children, obtaining a pain report is difficult and can be dependent on the interviewer’s
approach to the child, as well as the environment, mood, and character of the child.
Despite extensive research, one single pain assessment tool suitable for all children
has not been found. According to the systematic review by Tomlinson et al. , the WBFPRS is preferred by both children and parents.[5 ] However, the smiles and tears of the WBFPRS might confound pain intensity with affect
when obtaining a report about a medical procedure. Some studies suggest that the use
of WBFPRS generates higher pain scores than the use of other validated pain faces
scales, such as the FPS-R.[5 ]
[6 ]
In the present study, we produced a video showing in simple ways what an LP is, why
it is done and explaining the anatomy and structures of the back and the spinal cord.
One could argue that ideally, preprocedural preparation should be individualized.
Younger children should be informed and prepared by playing, adolescents should be
given the time and possibility to process and discuss the given information without
the caregivers’ presence, and the amount of information should differ for each patient
according to their individual needs, which is in line with what many authors avocates.[14 ]
[15 ] Preparation in a group, as in the present study, is associated with limitations
and cannot be expected to give the same positive effects that individual preparation.
Further, we believe that the preprocedural preparation would be better if given verbally
by a nurse or a social worker with adequate training and engagement, rather than as
a video. However, given the limitations in a busy and crowded department in an underresourced
hospital, the positive results of our study are encouraging. An existing informational
material, as the video produced here, is a robust method, and the quality of information
will thus not depend on the presence and availability of trained staff. Furthermore,
in a low-resource setting, preparation in group is less vulnerable and less demanding
and thus an acceptable alternative to individual counseling.
Conducting this study was associated with several ethical considerations. Administering
our questionnaire after the procedures might have caused negative emotions, as sensitive
questions regarding the family situation and the reason for the child’s hospitalization
were asked. In the setting where this study was performed, such questions are rarely
freely discussed. To raise questions about the disease and situation of every individual
patient could have a negative impact on the emotional and psychological well-being
of the child and its parents. This is problematic, as resources at this and similar
low resource hospital are scarce and the possibilities for individual counseling are
limited. However, as the interviews were conducted by interpreters from the local
cultural background, much caution and attentiveness were used when asking sensitive
questions. Overall, the potential positive effects of creating new routines for patient
information and preprocedural preparation, as well as of raising the awareness among
the staff at the pediatric oncology unit, are believed to overweigh the risk of possible
negative effects.
This study was conducted in an undermanned, underresourced hospital, which is associated
with many limitations, including unpredictable turns of the day and logistical obstacles.
First, we did not reach our level of inclusion, 76 children were included instead
of the planned 128. Second, the questionnaire used for this study was written in English
and translated by the interviewer while conducting the interviews in Telugu. The interviews
were conducted in the ward, sometimes in a crowded environment. Thus, there is a reason
to doubt the total homogeneity of the interviews. However, all but a few interviews
were conducted by the same interpreter, which decreases the risk of bias due to different
formulation of questions. It should also be noted that regardless of the available
resources, interviewing young children in a completely homogeneous way is not possible,
as some children require more explanation and introduction than other in order to
answer questions. Further, the interviews with the patients and caregivers were mostly
conducted in the presence of both the patient and the caregiver, allowing them to
be biased by each other’s answers. Furthermore, other patients and caregivers were
present during some interviews, which could have influenced the answers of the interviewees.
A strength of this study is that nearly all the eligible patients participated, meaning
that almost all patients who underwent a LP during the data collection period were
interviewed. This allows us to assume that the results can be generalized to similar
health-care settings in LMIC with lacking resources and a high patient burden from
underprivileged families, a situation for the majority of childhood cancer patients
in the world. In our study, the preparation had a positive effect, despite its many
weaknesses. Hence, we conclude that, even in settings where time and resources do
not allow ideal preparation, information and attention around an upcoming medical
procedure give the patients and their families a better understanding and a more positive
experience. It is of importance for hospitals such as where the study was undertaken
to acknowledge that efficient preparation can be achieved with small means and that
there is a need of increased awareness, as well as better pain relief, when performing
medical procedures in children.
Conclusions
The majority of pediatric patients who undergo LPs at the hospital where this study
was conducted experience treatment-requiring levels of procedural pain. Medical doctors
who perform the LPs underestimate the patients’ pain. Preprocedural information and
preparation, adapted to the situation at the hospital, are feasible and are found
to be efficient in informing patients and their caregivers about the reason for the
LP. In the present study, we found a decrease in self-reported procedural pain following
preprocedural preparation. However, in addition to information, further pain-relieving
interventions are required to achieve a satisfactory procedural pain management in
childhood cancer patients undergoing LP in low-resource settings.
Appendices
Appendix 1: Questionnaire
Questions to be asked to the patients:
How much pain did you experience during this procedure? Please point on this scale
that indicates no pain here (point on face 0 and on 0 on Colored Analog Scale [CAS])
and the worst pain you can imagine here (point on face 10 and on 10 on CAS).
If needed: This face does not hurt at all (0), this face hurts just a little bit (2),
this face hurts a little bit more (4), this face hurts even more (6), this face hurts
a whole lot (8) and this face hurts worst (10). Which face did you feel like during
the procedure?
These faces are showing different amounts of being scared. This face (point on face
0) is not scared at all, this face is a little bit more scared (point on face 1),
more scared (point on face 2), even more scared (point on face 3) and the most scared
possible (point on face 4). Have a look at these faces and choose the one that shows
how scared you were during the procedure.
Do you know why this procedure was done?
Do you know which disease you have?
Questions to be asked to the care-givers:
How much pain do you think that your child experienced during this procedure? Please
point on this scale that indicates no pain here (point on face 0 and on 0 on CAS)
and the worst pain you can imagine here (point on face 10 and on 10 on CAS).
How much fear do you think that your child experienced in connection with this procedure?
Please point on this scale that indicates no fear here (point on face 0) and the worst
fear you can imagine here (point on face 4).
Do you know why this procedure was done?
Do you know which disease your child has?
Questions to be asked to the staff performing the procedure:
How much pain do you think that the patient experienced during this procedure? Please
point on this scale that indicates no pain here (point on face 0 and on 0 on CAS)
and the worst pain you can imagine here (point on face 10 and on 10 on CAS)
How much fear do you think that the patient experienced in connection with this procedure?
Please point on this scale that indicates no fear here (point on face 0) and the worst
fear you can imagine here (point on face 4).
Appendix 2: Script for preprocedural preparation
Children, soon you will have a procedure called intrathecal chemotherapy. For this,
you will go to a different part of the hospital, where you might not have been before.
There is usually a big crowd of people there and a lot of noise. Then there is a special
room for the intrathecal therapy. In the room, there will be quite many people that
you have not seen before. A doctor, a nurse, and a few other adults. But you will
go there together with your parents. When it is your turn, you will be asked to lie
down on a bed in this position (show). So you will try to look like a ball, showing
your back to the doctor. Try it! Then, the parents, you will hold your child like
this (show all the parents).
Then if you touch the middle of your back with your hand, you can feel something hard,
this is called the spine. Do you feel it? Try! Inside the spine there is a fluid,
it looks like water. This water is inside all your spine, all the way up to your head
and also around your brain. Sometimes, when you are sick, the disease can swim around
in this water. What we need to do now, is to put a medicine into the water, which
will try to catch the disease and take it away. The medicine will also swim around
all your back and around your brain, trying to catch the disease and take it away.
If the disease goes away, you feel much better and you are not sick any more. This
is why it is important to do this procedure.
In order to put the medicine inside the water in your back, we need to put a needle
into the place in your back, where this water is. So when you lie on the bed like
this, the doctor will touch your back, to find the place where the water is. Then,
s/he will wash your back with something wet and then to put the medicine inside, s/he
will put a small needle in the place where the water is. This can hurt a bit, but
it is very quickly over. About half an hour before the procedure, you will get a cream
on your back – this cream makes the pain from the needle smaller.
When we are finished, we put a little plaster on your back and then you have to lie
down for half an hour. After that you can go to play or do whatever you want again.
It is not dangerous to put the needle in your back. It hurts a bit, but then it’s
over.
So when we do the procedure, you have to lie in this position – like you are trying
to be a ball. You have to lie very still and because of this, your parents will hold
you very hard, so that you can’t move. It is scary when somebody is holding you so
hard, but it is necessary to make sure you don’t move and we can make a good procedure.
Try to breathe calmly and stay still and think of something else, not the procedure,
for example, you can tell your mum or dad about your favorite place or favorite game
or something else that you like.
For the parents, it is important to stay calm, because then also your child is calm.
It is good if you distract your child, maybe by telling them a story or playing a
spoken game with them. If your child is very small, it is also important that you
hold the child firmly, so firmly that they cannot at all move – this will make your
child upset but it will make the procedure much quicker and less scary if you do it.
You can bring a cushion/teddy bear for your child to hug if you think it makes it
easier for them to lie still in the ball position. Does anybody have any questions?
