Validity and reliability of neonatal infant pain scale (NIPS) in neonatal intensive care unit in Vietnam
MedPharmRes, 2019, 3
1
MedPharmRes
journal of University of Medicine and Pharmacy at Ho Chi Minh City
Original article
Validity and Reliability of Neonatal Infant Pain Scale (NIPS) in Neonatal
Intensive Care Unit in Vietnam
Hai Thanh Ngoa, Kathleen Fitzsimmonsb, Kien Gia Toc*
aVINMEC General Hospital; 208 Nguyen Huu Canh, Ward 22, Binh Thanh District, Ho Chi Minh City, Vietnam;
bGreenville County Schools, Greenville, South Carolina, USA;
cFaculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City; 217 Hong Bang, Ward 11, District
5, Ho Chi Minh City, Vietnam.
Received July 14, 2018: Revised June 11, 2019: Accepted July 04, 2019
Abstract: Background: The study aimed to culturally adapt and validate Neonatal Infant Pain Scale (NIPS)
for use in Vietnamese settings. Methods: The original NIPS was translated into Vietnamese using a standard
protocol. Registered nurses of Neonatal Intensive Care Unit (NICU), Tien Giang General Hospital, Vietnam
used the Vietnamese NIPS for assessing neonatal pain and then provided feedback on acceptability of the scale.
Five registered nurses of NICU were randomly selected and used NIPS for assessing neonatal pain while
watching thirty videos at two times, two weeks apart from each other. Pulse rates per minute and oxygen
saturation (SpO2) were also recorded for validity evaluation. Intraclass correlation coefficients (ICC) with two-
way random effects were applied to assess intra-rater and inter-rater reliability. Multilevel linear regression was
applied to assess the association between NIPS score with pulse rates and SpO2 adjusting for raters, three
periods and two assessments. Results: The Vietnamese NIPS was accepted and valued by nurses at the NICU.
ICCs between the first and second assessments were from 0.53 to 1.00 for five raters before, during and after
clinical procedures showing moderate to excellent intra-rater reliability. ICCs among five raters were moderate
to good before and after, but poor (ICC<0.4) during clinical procedures. NIPS score was not associated with
SpO2, but with pulse rates per minute. Conclusions: The preliminary results showed that the Vietnamese
version of NIPS is reliable and should be used. However, it is recommended that further research should be
conducted to confirm its reliability and validity.
Keywords: NIPS, reliability, validity, NICU, Vietnam.
1. INTRODUCTION
Literatures showed that neonates experience many painful and
stressful procedures in Neonatal Intensive Care Unit (NICU)
[3-5].
Pain is defined as “an unpleasant sensory and emotional
experience associated with actual or potential tissue damage
or described in terms of such damage” [1]. Pain in neonates
has been extensively studied in recent years and evidence
suggests that neonates experience pain much more severe than
adult or older children do as neonatal pain seriously affects
development of nervous system and growing of babies [2].
Pain should be assessed for optimal care of neonates in
NICU [5, 6]; however, assessing pain is very difficult and
complicated, particularly in neonates as they are unable to
verbally communicate [5, 7]. Although some validated and
reliable pain scales are available for assessing neonatal pain,
*Address correspondence to Kien Gia To at the Faculty of Public Health,
University of Medicine and Pharmacy at Ho Chi Minh City; 217 Hong Bang,
Ward 11, District 5, Ho Chi Minh City, Vietnam; Tel/Fax: (+84) 91 95 11 121;
DOI: 10.32895/UMP.MPR.3.2.1
© 2019 MedPharmRes
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To et al.
they are rarely used in clinical practice and most of the scales
are in English which require translation and cross-cultural
adaptation for use in local contexts [4, 5, 8-11].
NIPS has the advantage that it does not require users have
additional skills or equipment to assess pain and would be a
good tool for assessing and improving pain management of
neonates [2, 4]. Moreover, it is valid and reliable and has been
used worldwide [10, 13-15]. A study conducted in a southern
California hospital to assess the inter-rater reliability of NIPS
using 27 neonates with 100 medical procedures showed high
Cronbach’s Alpha coefficients of 0.9, 0.9, and 0.86 before,
during and after medical procedures [14]. Moreover,
Pearson’s correlation coefficients of 0.82, 0.75 and 0.81
showed good inter-rater reliability between three raters
including a nursing faculty, a senior resident doctor and a
post-graduate neonatal nurse [14]. NIPS was successfully
translated into Persian with good inter-rater reliability of 0.87
and excellent intraclass correlation coefficient of higher than
0.9 [15]. The Brazilian version of NIPS provided a
Cronbach’s alpha of 0.76, a kappa score of 0.93, inter-rater
reliability of 95% and intra-rater reliability of 90% [10].
Neonatal Infant Pain Scale (NIPS) was developed by
Lawrence et al. at Children’s Hospital of Eastern Ontario to
assess pain in neonates based on behaviors. Their study
included videotaping 90 medical procedures of 38 neonates
before, during and after procedures [12]. The Cronbach’s
Alpha coefficients before, during and after procedures were
0.95, 0.87 and 0.88, respectively. The Pearson correlation was
0.92 to 0.97 showed good inter-rater reliability. NIPS includes
six items assessing six states of neonates including facial
expression, cry, breathing patterns, movement of arms,
movement of legs and state of arousal. Each item is scored 0
to 1, except state of cry is scored 0, 1 and 2, for a possible total
score of 7. Neonates have no pain if NIPS score is 0-2,
moderate pain if NIPS score is 3-4 and severe pain if NIPS
score is more than 4.
Translation process
Obtaining
permission
Vietnamese
translation
Original
version
English
translation
Synthesis
Expert panel
14 nurses of NICU were asked to assess if NIPS was
understandable, usable, practical, not time-
consuming, supportable to decision making, and
possible to classify pain.
Pilot study
15 neonates were given an intramuscular
injection, and another 15 were given an
intravenous catheter insertion
Video-recorded
5 nurses were randomly selected from the NICU to
assess 30 videos using Vietnamese NIPS
Baseline
assessment
Two weeks
The 5 nurses were asked to use the Vietnamese
NIPS to reassess the 30 videos
Second
assessment
Figure 1: The study process
Psychometric properties of Vietnamese NIPS
MedPharmRes, 2019, Vol. 3, No. 2 3
In Vietnam, assessing neonatal pain in NICU has not been
a routine practice as few studies have been done to provide
supporting evidences. Moreover, valid and reliable scales
were not available. Therefore, the aim of this study was to
cross-culturally adapt NIPS for use in Vietnamese hospitals
and assess its validity and reliability. The study is a useful
reference for practitioners to manage neonatal pain in NICU,
and for students and researchers to do their studies.
deviation of 7 items and the duration of assessment were
calculated.
2.4. Main study to assess validity and reliability of NIPS
Thirty neonates hospitalized in the NICU and prescribed
an intramuscular injection (15 neonates) and an intravenous
catheter insertion (15 neonates) were recruited for the study.
A total of 30 videos was recorded. The neonates having Apgar
scores of at least seven were selected based on consultation
with medical doctors. These neonates were monitored for
pulse rates per minute and oxygen saturation (SpO2) before,
during and after intramuscular injection and catheter insertion.
Literature shows that pulse rates were positively associated
with painful level whereas SpO2 was negatively associated
[18-20]. All the above clinical interventions were normal
procedures in the care of neonates in the NICU of the hospital.
Neonates who were prescribed painkillers, had congenital or
nervous abnormalities, used respiratory support-device, or
had birth by Caesarean section were excluded from the study.
A researcher screened for the eligibility of neonates. He
approached and explained the study to parents of eligible
neonates and asked if they allowed their neonates
participating in the study. If they agreed, they were asked to
sign an informed consent before their neonates participating
in the study.
2. METHODS
2.1. Study setting
The study was conducted at Tien Giang General Hospital
located in My Tho City, Tien Giang province, Mekong Delta,
the South of Vietnam. Tien Giang has an area of 2,367 km
squared and a population of 1.7 million. The hospital was
founded in 1921 and is responsible for healthcare of people
from Tien Giang and nearby provinces. The NICU of Tien
Giang General Hospital has 14 nurses who are responsible for
caring for under-one-month old neonates.
2.2. Translation process
A registered nurse and an English teacher independently
translated NIPS into Vietnamese. Two Vietnamese copies
were compared, differences noted, and were then synthesized
by one researcher. The final Vietnamese version of NIPS was
independently back translated into English by another
registered nurse and English teacher. The English-backward
translated versions of NIPS were compared with the original
NIPS. Again, differences were discussed among a pediatrist
and two registered nurses who are native English speakers
until a consensus was reach. The final Vietnamese version of
NIPS was reviewed and accredited by an expert panel of Tien
Giang General Hospital. The study process is presented in
Figure 1.
Five nurses were randomly selected from all nurses of the
NICU. The inclusion and exclusion criteria were the same as
those had been used in the pilot study. These five nurses were
asked to use NIPS to assess pain of neonates. After two weeks,
the same five nurses were asked to re-assess the videos using
the same tool. The two-week interval was considered
appropriate to assess the intra-rater reliability [10]. The
sample size of 30 videos and five raters was acceptable for
reliability study [21].
2.5. Statistical analysis
2.3. Pilot study to assess the characteristics of the
Vietnamese version of NIPS
All statistical analysis was performed using STATA13.
All nurses were asked to watch 30 videos and use NIPS to
assess the pain of recorded neonates. Two weeks after the first
assessment, they were asked to re-assess the videos. Intra-
rater reliability was calculated to assess a difference in NIPS
mean score of five raters between two assessments (first and
second assessment) at three periods (before, during and after
clinical intervention) using group-average intra-class
correlation coefficient (ICC) with two-way mixed-effects
absolute agreement model [21]. Intra-rater reliability of each
of five raters between two assessments at three periods was
also calculated using individual ICC with two-way mixed-
effects absolute agreement model [21]. Inter-rater reliability
was assessed using individual ICC with two-way random-
effect absolute agreement model [21-25]. ICC was classified
as poor (ICC < 0.5), moderate (0.5 ≤ ICC ≤ 0.75), good (0.75
< ICC ≤ 0.9), and excellent (ICC > 0.9) reliability [21].
Registered nurses, who were working at Neonatal
Intensive Care Unit (NICU) of Tien Giang general hospital,
were invited to participate in the pilot study. Inclusion criteria
were nurses working at the NICU of Tien Giang General
Hospital and responsible for caring newborn babies.
Participants were excluded if they were a probationer or
experienced less than one working year at the hospital. A
researcher approached all nurses of NICU and screened for
their eligibility. If they were eligible, they were informed
about the purpose of the study and invited to participate in it.
If they agreed, they were asked to sign an informed consent
before joining the study. All 14 nurses were eligible and were
trained to use the Vietnamese NIPS as suggested by Gallo [2].
They were then asked to use the tool to assess pain level of
newborn babies in the NICU as well as answer-seven
questions to assess whether the NIPS was 1) clear and easy to
understand, 2) easy to use, 3) convenient for use, 4) time-
consuming, 5) helpful for nurses to decide when to treat pain,
6) practical to use in clinical practice, and 7) able to classify
levels of pain. The seven questions were Likert-style scales
and successfully used in previous studies [16, 17]. Each item
was rated from 1 (strongly disagree) to 5 (strongly agree).
Moreover, the length of time needed by nurses to complete the
assessment was recorded and reported. The mean and standard
As pulse rates per minute and SpO2 predicted level of pain
[18-20], they were used to assess NIPS validity. Associations
between pulse rates per minute and SpO2 with NIPS score
were checked using multilevel linear regression. Three levels
were raters (five nurses), three periods of the clinical
procedures (before, during, and after), and two assessments
(first or second). The total number of observations of 30 videos
of five raters in three periods after two assessments is 900.
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2.6. Ethical issues
(55/ĐHYD-HĐ/2017); and accepted by the Executive Board
of Tien Giang general hospital.
The study was approved by the ethics committee of the
University of Medicine and Pharmacy at Ho Chi Minh City
3. RESULTS
Table 1: The difference between the original NIPS and English-back translation of its Vietnamese version
English-back translation of Vietnamese NIPS The original NIPS (Lawrence et al., 1993)
Facial Expression
Facial Expression
0 – Relaxed muscles
Restful face, neutral expression
0 – Relaxed muscles
Restful face, neutral expression
1 – Grimace
Tight facial muscles, furrowed
brow, chin, jaw
1 – Grimace
Tight facial muscles, furrowed
brow, chin, jaw
Cry
Cry
0 – Not crying
1 – Whimper
2 – Vigorous cry
Quiet, not crying
0 – No cry
1 – Whimper
2 – Vigorous cry
Quiet, not crying
Mild moaning, intermittent
Loud scream, shrill, continuous
(Note: Silent cry may be scored if
the infant is intubated, when there
is evidences by obvious mouth,
facial movements)
Mild moaning, intermittent
Loud scream, shrill, continuous
(Note: Silent cry may be scored if
baby is intubated, as evidenced by
obvious mouth, facial movement)
Breathing Patterns
Breathing Patterns
0 – Relaxed
Usual breathing pattern
0 – Relaxed
Usual breathing pattern for this
baby
1 – Change in
breathing
Arms
Indrawing, irregular, faster than
usual, gagging, breath holding
1 – Change in
breathing
Arms
Indrawing, irregular, faster than
usual, gagging, breath holding
0 – Relaxed
/restrained
No muscular rigidity, occasional
random movements of arms
0 – Relaxed
/restrained
No muscular rigidity, occasional
random movements of arms
1 – Flexed /extended
Tense, straight arms, rigid and/or
rapid extension/flexion
1 – Flexed /extended
Tense, straight arms, rigid and/or
rapid extension/flexion
Legs
Legs
0 – Relaxed
/restrained
No muscular rigidity, occasional
random movements of legs
0 – Relaxed
/restrained
No muscular rigidity, occasional
random leg movement
1 – Flexed /extended
Tense, straight legs, rigid and/or
rapid extension/flexion
1 – Flexed /extended
Tense, straight legs, rigid and/or
rapid extension/flexion
State of Arousal
State of Arousal
0 – Sleeping /awake
Quiet, peaceful, sleeping or alert
and stabilized
0 – Sleeping /awake
Quiet, peaceful, sleeping or alert
and settled
1 – Fussy
Alert, restless, and thrashing
1 – Fussy
Alert, restless, and thrashing
*Total score from 0 to 7
0-2: no pain; 3-4: moderate pain; >4: severe pain
Table 2: The characteristics of Vietnamese version of NIPS were assessed by 14 nurses at Neonatal Intensive Care Unit (NICU),
Tien Giang General Hospital
Characteristics of NIPS
NIPS is clear and understandable
NIPS is easy to use
NIPS is convenient for nurse
NIPS is less time-consuming
NIPS helps nurse give decision on medical care
NIPS is feasible and applicable to clinical context
NIPS is able to classify pain level
Mean± SD
4.4± 0.6
4.1± 0.6
4.0± 0.4
3.9± 0.5
3.4± 0.5
3.6± 0.5
3.5± 0.5
Min
3
3
3
3
3
3
3
Max
5
5
5
5
4
4
4
SD: standard deviation; Min: Minimum; Max: Maximum
Psychometric properties of Vietnamese NIPS
MedPharmRes, 2019, Vol. 3, No. 2 5
Table 3: The group-average and individual intra-rater reliability of NIPS before, during and after clinical procedures
Before During After
ICC ICC
ICC
p
p
p
(95%CI)
0.92
(95%CI)
0.81
(95%CI)
0.99
Overall intra-rater
Rater 1
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
(0.88; 0.94)
0.72
(0.73; 0.86)
0.85
(0.98; 0.99)
0.94
(0.50; 0.86)
0.84
(0.70; 0.92)
0.84
(0.70; 0.92)
0.84
(0.70; 0.92)
0.93
(0.72; 0.93)
0.53
(0.22; 0.75)
0.67
(0.42; 0.83)
0.88
(0.77; 0.94)
0.66
(0.88; 0.97)
1
Rater 2
(1; 1)
1
(1; 1)
1
(1; 1)
0.97
Rater 3
Rater 4
Rater 5
(0.85; 0.96)
(0.40; 0.82)
(0.93; 0.98)
ICC: intraclass correlation coefficient; 95%CI: 95% confidence interval
Five nurses assessed 30 videos in first and second assessment for group-average intra-rater reliability using two-way mixed-
effects absolute agreement model.
For each rater, individual intra-rater reliability was reported using two-way mixed-effects absolute agreement model.
Table 4: The inter-rater reliability of NIPS between five nurses using NIPS to assess pain score before, during and after clinical
procedures at the first and second assessment
Before (n=30)
ICC
(95%CI)
During (n=30)
ICC
(95%CI)
After (n=30)
ICC
p
p
p
(95%CI)
0.60
0.77
(0.66; 0.87)
0.77
0.28
(0.14; 0.48)
0.33
First assessment
<0.01
<0.01
<0.01
<0.01
<0.01
<0.01
(0.45; 0.75)
0.63
Second assessment
(0.66; 0.87)
(0.18; 0.53)
(0.48; 0.77)
ICC: intraclass correlation coefficient; 95%CI: 95% confidence interval
Five nurses assessed 30 videos, two-way random-effects absolute agreement model was used to assess inter-rater reliability
Table 5: Multilevel linear regression assessing the association of NIPS score with SpO2 and pulse rates per minute adjusting for
raters, period (before, during and after clinical intervention) and time (first vs. second assessment) (n=900)
SpO2 (%)
Pulse rates per minute
Coef.
-0.15
p-value
95%CI
-0.51; 0.20
Coef.
3.25
p-value
95%CI
NIPS score
0.40
<0.01
1.19; 5.31
Rater 1
1
-0.02
-0.01
-0.00
0.01
1
0.45
0.14
0.05
-0.27
1
Rater 2
0.95
0.98
0.99
0.97
-0.68; 0.63
-0.66; 0.65
-0.66; 0.65
-0.64; 0.67
0.82
0.94
0.98
0.89
-3.34; 4.24
-3.64; 3.92
-3.72; 3.83
-4.05; 3.51
Rater 3
Rater 4
Rater 5
Before clinical intervention
During clinical intervention
After clinical intervention
1
-15.09
-0.14
0.01
<0.01
0.58
-17.50; -12.69
-0.65; 0.36
25.54
0.05
-0.15
<0.01
0.98
11.62; 39.47
-2.90; 2.99
-2.54; 2.24
Assessments (second vs.
first)
0.97
-0.41; 0.42
0.90
Multilevel linear regression model; Coef.: Beta coefficient; 95%CI: 95% Confidence Interval.
The translation of NIPS into Vietnamese appeared to be
successful as shown in Table 1. The English back translation
version kept the original meaning despite some minor
differences in wording.
the characteristics ranged from 3.4 points for “helps nurses
give decision on medical care” to 4.4 points for “clear and
understandable”. The mean duration NIPS took nurses was
1.6 minutes ranging from one to two minutes.
Table 2 shows the characteristics of the Vietnamese
version of NIPS assessed by 14 nurses at the NICU, Tien
Giang General Hospital. On average, assessment points for
Group-average ICCs of five nurses showed excellent intra-
rater reliability before (ICC=0.92, 95%CI: 0.88-0.94) and
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To et al.
after (ICC=0.99, 95%CI: 0.98-0.99) clinical procedures, but
good (ICC=0.81, 95%CI: 0.73-0.86) during clinical procedure
(p<0.01) (table 3). All individual ICCs showed good to
excellent agreements (ICC ≥ 0.84) with the exception of rater
1 before clinical procedures, and rater 2, 3, 5 during clinical
procedure just showing moderate agreement (ICC=0.53 to
0.72, p<0.01).
This study used SpO2 and pulse rates per minute which were
objective measures to assess validity of the NIPS. Although the
NIPS score was not significantly associated with SpO2, it was
positively associated with pulse rates. This finding may reflect
the inconsistent results in previous studies. While some showed
that heart rate increased and SpO2 decreased during painful
procedures [15, 18], the other found that heart rate and SpO2 were
not sensitive and not associated with pain scores [29].
At first and second assessments, almost 100% videos were
rated no pain before clinical procedure at the first and second
assessments. Five nurses showed good agreements
(ICC=0.77, 95%CI: 0.66-0.87) before clinical procedures,
poor agreements (ICC=0.28, 95%CI: 0.14-0.48 and 0.33,
95%CI: 0.18-0.53) during clinical procedures, and moderate
agreements (ICC=0.60, 95%CI: 0.45-0.75 and 0.63, 95%CI:
0.48-0.77) after clinical procedures (p<0.01) at the first and
second assessments (table 4).
Our study has some limitations. Firstly, due to very low
variability, it was unable to calculate internal consistency for the
entire scale. Secondly, although there are many clinical
procedures conducted in the NICU, only two clinical procedures
were observed in this study, including intramuscular injection
and intravenous catheter insertion. Thirdly, the sample size is
small and the study was only conducted in one hospital in the
South of Vietnam. Therefore, the results may not be
generalizable to other areas of the country.
After adjusting for raters, periods and assessments, the
multilevel linear regression showed that NIPS score was not
significantly associated with SpO2 (p>0.05). However, for
every point increase in NIPS score, pulse rate per minute
increased three beats (p<0.01) (Table 5).
In conclusion, the preliminary results showed that the
Vietnamese version of NIPS showed acceptable reliability for
use in clinical settings. As there was currently no validated tool
for assessing neonatal pain available in Vietnamese, this tool
should be used although it is recommended that further research
should be conducted to confirm its reliability and validity.
4. DISCUSSION
LIST OF ABBREVIATIONS
This study translated and adapted the original NIPS into
Vietnamese using the process guided by World Health
Organization [26]. English-Vietnamese and Vietnamese-English
translations of NIPS is highly consistent. The Vietnamese version
of NIPS were also reviewed and accredited by experts and
experienced NICU nurses. In order to apply the NIPS, it is
important that hospitals’ nurses accept and are willing to use it.
Our study indicated that all nurses agreed that the Vietnamese
version of NIPS is applicable in the local hospital context.
ICC: intra-class correlation coefficient; NICU: Neonatal
Intensive Care Unit; SpO2: Oxygen saturation.
CONFLICT OF INTEREST
The authors declare that they have no competing interests.
ACKNOWLEDGEMENTS
We would like to thank Dr. Quyen Gia To, Queensland
University of Technology, for his helpful advice on statistics.
Our special thanks should go to nurses of Neonatal Intensive
Care Unit and the Executive Board of Tien Giang Hospital for
accepting the study. We also thank Dr. Deborah Kupecz for
her helpful comments on translation; the reviewers for their
useful comments on the manuscript; and all participants for
participating in this study. All other contributions to the study
should be acknowledged.
The NIPS mean score indicated that neonates have almost no
pain before and after procedures but severe pain during them.
Neonatal pain is highly frequent in NICU because neonates
suffered seven invasive procedures per day on average and a half
of them had at least pain once during their hospitalization [27].
Compared to other neonatal pain assessment tools, NIPS is easy
to use and not time-consuming; and does not require extra
equipment [5]. Therefore, NIPS is applicable in NICU.
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The Vietnamese version of NIPS had good test-retest
reliability as its average ICCs of five raters were above 0.75
before, during and after clinical procedures, and individual ICCs
were from moderate to excellent (0.53 to 1). Five raters showed
good agreements (ICC=0.77) before clinical procedures and
moderate agreements (ICC≥0.60) after clinical procedures at first
and second assessment. However, poor agreement (ICC<0.4)
were detected between the five raters during clinical procedures
at the two assessments. As rater 2 had lower ICCs during clinical
procedures, this rater was removed from the calculation. ICCs
were re-calculated among the other four raters which improved
to 0.51 at the first assessment and 0.49 at the second assessment.
A possible explanation was that four raters had different level of
clinical experiences from the rater 2 as an experienced pediatric
nurse tends to rate lower pain score [28]. However, the
explanation could not be confirmed as personal data of raters
were not collected in this study. More training on how to identify
different aspects of pain may be provided to nurses to help
increase inter-rater reliability.
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