The role of the physical therapist (PT) in neonatal care has expanded as experts have become increasingly concerned with improving the quality of life for infants with very low birth weight (VLBW; <1500 g) who survive neonatal intensive care.1,2 Therefore, the effects of handling on the infant with VLBW should be of utmost concern to the neonatal PT to enable this group of clinicians to monitor and implement changes in their and other neonatal caregivers’ practices.
Handling procedures in the neonatal intensive care unit (NICU) have been observed as being frequent, painful, stressful, and often unnecessary.3–7 These handling procedures are associated with adverse behavioral, physiological, and hormonal events like behavioral distress, hyperactivity, inappropriate sleep patterns, decreased weight gain, autonomic instability, changes in cortisol levels, hypoxia, and heart rate instability.4,7–15 Furthermore, infants with VLBW also are predisposed to the sequelae of untreated and prolonged pain, such as altered development of pain systems, behavior, cognition, etc., because of their immature pain pathways.14,16 As a result, experts suggest that there is a link between the stimuli infants with VLBW are exposed to in the NICU and their long-term developmental outcomes.17–19
In contrast, social and maternal touch has been found to have positive effects on the weight gain and behavior of infants born with VLBW.20,21 However, the infant receiving neonatal intensive care is thought to receive inadequate social and maternal touch,4,22 with Werner and Conway5 observing for a group of 10 infants born VLBW only 21.75 minutes of direct social contact across a period of 1100 minutes (18 hours, 20 minutes).
To protect the neurodevelopment of the infant born with VLBW and improve practice in neonatal intensive care, there has been an emphasis in medical and neonatal journals in recent years toward the following philosophies: the humane neonatal care initiative,22,23 individualized developmental care,15,19,24–26 and family-centered neonatal intensive care.27,28 In the humane approach to neonatal intensive care, technical handling is minimized and maternal contact is encouraged.22,23 This has been shown to lead to faster weight gain by the infant with VLBW, more advanced social and psychological development, and early discharge.22 Individualized developmental care for neonates incorporates environmental modification in addition to minimizing routine handling procedures, maximizing rest periods, clustering care giving, evenly distributing care giving during a 24-hour period and actively involving parents. This has been found to improve overall motor development and medical outcome variables with infants requiring fewer days on oxygen or ventilation, decreased incidence of intraventricular hemorrhage, better autonomic stability, and improved self regulatory skills.15,29,30 Family-centered neonatal intensive care promotes the family’s role as a partner in the delivery of their infant’s care.24,27,28 This contributes to parents’ improved satisfaction with care, decreased parental stress, shorter hospital stay, greater success with breastfeeding, and so forth.24
These philosophies have increased awareness of the needs of the infants receiving neonatal intensive care and their families. They also have focused attention on ensuring that adequate pain relieving and pain-prevention strategies are adopted by caregivers. Therefore, even though one particular approach may not have been adopted and implemented by a NICU, the focus on these approaches and the increased awareness of these philosophies may have altered care giving in the current day NICU. However, this is unknown as studies which have investigated caregiving practices in NICUs are dated.3–5,7,19 Additionally, pain responses of infants receiving neonatal intensive care have only been investigated with regard to specific handling events, eg, heel prick, nappy (ie, diaper) changes. Investigation of specific pain responses to general caregiving practices would aid caregivers in monitoring the effects of their handling and would provide information as to whether current neonatal care giving is considering the needs of the infant and applying pain prevention and pain relieving strategies appropriately.
This study was designed to investigate the effects of handling episodes on the pain responses of the infant born with VLBW, measured using the Neonatal Inventory Pain Scale (NIPS),31 and the frequency, duration and type of handling procedures during a total of 24 hours’ observation, for the infant born with VLBW while in the NICU.
A nonexperimental observational study was conducted at the NICU of Al Wasl Hospital and Dubai Hospital in the United Arab Emirates (UAE) from January to May 2005. Two tertiary level NICUs were selected by convenience to establish more representative figures for neonatal handling practice in the UAE. Aside from providing the necessary medical and nursing care to the infants in their respective NICUs, neither NICU had adopted any developmental, family-orientated, or therapeutic approach aimed at improving infant outcomes. Postural support of the infants was not provided on a routine basis. Both of the NICUs however, did allow unlimited parental visitation.
The study was approved by the Institutional Review Board of the University of Sharjah and also the Dubai Department of Health and Medical Services. Informed consent was obtained from the parents before the infants were entered into the study. The observers and the infants’ parents were not blinded to the aims of the study because of logistical limitations and informed consent. The caregiving personnel were blinded to the specific aims of the study.
The eligibility criteria were selected to obtain a sample of infants born with VLBW who required handling associated with their intensive care needs and excluded circumstances where additional handling would be required, eg, congenital abnormalities that would require specific physiotherapy or technical interventions. Infants who were sedated but not paralyzed were not excluded. It was considered important to include infants who were sedated due to its role as a pharmacological pain management strategy.
Inclusion criteria included birth weight <1500 g, between two and 21 days of age, born in the hospital, mechanically ventilated, and requiring neonatal intensive care. Exclusion criteria included congenital/musculoskeletal abnormalities, and any surgical intervention.
A convenience sample of 18 infants was recruited and observed, nine infants from each hospital site. During the recruitment process, the parents of five infants refused participation in the study.
The following instruments were administered during the course of this study: the NIPs and the Neonatal Medical Index (NMI). The NIPS31 provides a measure of the intensity of infant responses to pain or pain elicited stress and was documented before and after each handling episode in order to fulfill the principle aim of the study. The NMI32 provides a measure of the infants’ illness severity during their neonatal period. This information was required to enable further statistical analysis in relation to handling in the NICU.
The NIPS is a multidimensional pain scale developed specifically for the newborn. It is a simple, noninvasive observational scale. It includes six behavioral groupings: facial expression, cry, breathing patterns, arm movement, leg movement, and state of arousal. Cry has three descriptors (0 = no cry, 1 = whimper, 2 = vigorous cry), each of the other behaviors has two descriptors with scores of 0 and 1. A total score, ranging from 0 to 7 can then be calculated. A lower score indicates that the infant is in less stress and pain. The scale has been developed to assess infants’ acute procedural pain responses before, during and/or after caregiving procedures. This tool has demonstrated construct validity, concurrent validity with visual analog scales (0.53–0.84), high interrater reliability (0.92–0.97) and internal consistency.31
The NMI provides a classification ranging from I to V, in increasing order of illness severity to the infant. This classification is based on the infant’s medical course during the neonatal stay and includes variables such as birth weight, oxygen or ventilatory support, and the presence of additional medical complications, eg, respiratory distress syndrome, intraventricular hemorrhage, or periventricular leucomalacia.32 The NMI has demonstrated concurrent validity for use in discriminating between infants with different illness severity and predictive validity with the Bayley Developmental Quotient at 24 months and with the Stanford-Binet IQ at 36 months.32
A pilot study was conducted to test the suitability of the instruments and establish interrater reliability between Observer 1 and Observer 2, both physical therapists. Two observations at each hospital site were conducted simultaneously by Observers 1 and 2. Each infant (n = 4) was observed for a two-hour period, in accordance with the main study procedure described herein.
Throughout each observation, the two observers documented variables associated with each handling episode, where a handling episode was defined as direct physical contact with the infant by any person. The variables observed and documented for each handling episode were as follows: duration (using a digital stop watch), intensity, action, location, caregiver, and type of caregiving procedure. A complete list of operational definitions of these terms can be found in the Appendix. In addition the observers administered the NIPS before and after each handling episode. The interrater reliability (intraclass correlation model 3, 1) for the variables associated with each handling episode was ICC >0.85. The interrater reliability for the NIPS was ICC = 0.88.
This study aimed to obtain information related to the amount of handling to which an infant with VLBW in a NICU is exposed during a 24-hour period, midnight to midnight. To achieve this, infants recruited were observed for periods of two hours until a full 24-hour period had been observed at each of the two NICUs. The specific hours chosen for the observation of each infant on any given day were selected randomly. Six infants from each NICU were observed for one two-hour period with three infants from each NICU being observed for two two-hour periods. Observations for those infants who were observed on two occasions were conducted with a minimum of 24 hours’ gap between the observations. The observation periods were conducted according to subject recruitment and did not occur consecutively. Observations were carried out from November 2004 to May 2005.
Each two-hour observation was separated by a 15-minute rest period, taken after 60 minutes, to eliminate observer fatigue. The observations were conducted by Observer 1 or Observer 2. To ensure that the data collected represented handling frequency across different days, three weekend observations were conducted at each hospital site.
Before commencing each observation period, the observer introduced herself to the nursing staff, medical staff, and any member of family present and stated that she would be making environmental observations in the NICU. Baseline data: sedation, chronological age, and the exact time of observation commencement were collected for each infant at the start of the observation period. For each handling episode, the following variables were recorded: duration (using a digital stop watch), intensity, action and location, caregiver, type of procedure, if the procedure was invasive or noninvasive, and social or non-social (see Appendix). These aspects of the handling were included based on the recommendations of Liaw.17 The time and duration of parental visitation also was documented to establish the degree of parental contact and involvement taking place in each NICU.
Frequencies (%) and means (SD) were used to summarize subject characteristics. The NIPS were summarized using median (interquartile range) scores as a result of the rank nature of the data. The effects of the handling episodes on the NIPS was examined using the Wilcoxon signed ranks test or the McNemar test (dichotomous sub scales of the NIPS). The effects of procedure type (invasive/noninvasive; social/nonsocial) and caregiver on the NIPS were analyzed using the Mann–Whitney U test and the Chi-squared test, respectively. The relationships between handling episodes and the following variables were examined using bivariate correlation analyses: gestational age, birth weight, chronological age, time and type of day (day or night; weekend or week day) and the NMI, followed by multiple stepwise regression analysis if appropriate.
To achieve the second study aim, the variables associated with the handling episodes observed at the two NICUs were averaged to provide data relating to the observed handling during 24 hours of neonatal intensive care. Means (SD) were used to summarize data pertaining to handling duration, frequency and parental visitation in each NICU. Frequencies (%) were used to summarize the following variables associated with the handling episodes: procedure and procedure type (invasive/noninvasive; social/nonsocial), caregiver, intensity, action and location. SPSS version 10.0 (SPSS Institute, Cary, NC) was used to analyze the data. All tests were two-tailed, and a significance level of p ≤ 0.05 was regarded as significant.
The sample characteristics are presented in Table 1. All of the infants (n = 18) were singletons, intubated and mechanically ventilated at the time of the observation, with seven (29.2%) being sedated. The infants’ mean gestational age was 28.3 weeks (SD, 2.3 days) and mean BW was 962.2 grams (SD 251.4 g). Twelve (66.7%) of the infants were male, whereas six (33.3%) were female. Eight (44.4%) infants were Arabic, and six (33.3%) were Indian (Asian origin). Fourteen (77.8%) infants had a NMI score of Grade III, four (22.2%) had a Grade V classification. The infants were observed at a mean age of 5.7 (SD 2.8) days. Twenty-four, two-hour observations were conducted, six (25%) were conducted over the weekend, and 10 (41.7%) observations were conducted in the daytime (6 AM to 4 PM). Observer 1 and 2 conducted 11 (46.3%) and 13 (53.7%) observations, respectively.
Effects of Handling on the NIPS
The NIPS was significantly greater, median 1 (interquartile range 0–3), after the handling episode than before handling, median 0 (interquartile range 0-3), p < 0.001. Fifty-two (49.1%) handling episodes caused an increase in the NIPS, 46 episodes (43.4%) had no effect, and eight (7.5%) resulted in reduction of the infants’ pain on the NIPS. The scores on each subsection of the NIPS, ie, facial expression, cry, breathing pattern, arms and legs, were significantly greater after handling than before (p < 0.001, p = 0.011, p < 0.001, p = 0.001, and p = 0.001, respectively), except state of arousal (p = 0.052).
In summary, of the individual infant responses after a handling episode: 39 infants had an increase in their breathing pattern score; 22 infants had an increase in their facial expression score; 20 had an increase in their leg scores; 18 had an increase in their arm scores; and 10 had an increase in cry and state of arousal subsection scores. Table 2 summarizes the changes in the NIPS and the section scores of the NIPS in relation to the handling episodes.
The seven sedated infants underwent 15 handling episodes during the observations. The 11 infants who were not sedated had a total of 91 handling episodes. Sedated infants had a significantly lower pain response to handling than those who were not sedated (p = 0.027). After a handling episode, the median change in the NIPS for the sedated infants was 0 (range 0 to 1) where the infants who were not sedated had a median change in their NIPS scores of 1 (range −5 to 7).
Infants’ pain responses during handling episodes that contained social touch did not differ significantly from pain responses associated with handling episodes that did not contain social touch. Handling episodes that contained a noninvasive procedure did not significantly affect the infant’s pain response compared to handling episodes which were invasive in nature. Caregiver also did not influence infants’ pain responses.
Characteristics of the Handling Episodes
During 24 hours, infants with VLBW in the NICUs were disturbed an average of 53 (range 34–72) times and handled a total of 2.7 (range 1.44−3.92) hours. The handling episodes occurred on average every 22.25 minutes (SD 32.9; range 1.05–184 minutes), for an average of 3.04 minutes (SD 4.7; range 0.08−34.5 minutes). A mean of 1.9 procedures (SD 1.3; range 1 to 7) per handling episode were observed.
At the two NICUs an average of 99.5 (63 to 136) procedures were observed during 24 hours. Repositioning was the most frequent procedure n = 20.5 (18 to 23). The frequency of procedures conducted are itemized in Table 3. In 24 hours, a mean of 30.5 (18 to 43) procedures were classified as invasive, and a mean of 69 (range 43–86) were noninvasive (see Appendix).
Social touch was provided by either nurses or parents during only 6.5 (range 4–9) of the handling episodes. Stroking was the only procedure conducted for the purposes of social touch. Over the course of 24 hours, parents visited their infants an average of 2.5 (range 2–3) times a day, with the visits lasting a total mean of 7.29 (range 4.42−10.2) min/day. Parents handled their infants an average of five (range 4–10) times in 24 hours. It is unclear how long these interactions lasted, because they were not always provided in an isolated handling episode. However, during their interactions, they conducted the following caregiving procedures within 24 hours; repositioning (n = 4.5), stroking (n = 4.5), and nappy (diaper) changing (n = 1.5). Additional characteristics of the handling episodes are provided in Table 4.
There was no significant relationship between the duration and frequency of handling with gestational age (r = −0.276 and r = −0.315, respectively), birth weight (r = −0.164 and r = −0.079, respectively), chronological age (r = −0.067 and r = 0.147, respectively) or NMI score (rs = −0.054 and rs = −0.152, respectively). There were no significant differences between weekday and weekend observations or between day and night observations in relation to either the number or duration of episodes observed. Because of the lack of significance found between the aforementioned variables, further multiple regression analyses were not required.
The NIPS was significantly higher after handling than before handling (p < 0.001). Just more than half of the handling episodes (n = 52; 49%) caused an increase in the pain score as recorded by the NIPS. Interestingly, the infants’ pain responses were not affected by the types of handling (social/nonsocial; invasive/noninvasive) or by the caregiver despite evidence suggesting that there are physiological and behavioral benefits of social and maternal touch.20,21 Therefore, the results indicate that there is an infant pain response associated with general handling of caregivers indiscriminate of the aim of the handling. This result highlights the need for all neonatal caregivers, including those such as PTs who are providing handling interventions deemed to be enhancing infant development, to monitor the impact of their handling on infant pain and modify their handling accordingly. The results of this study also suggest that to achieve the documented benefits of social and maternal touch and to potentially reduce the pain associated with general caregiving, education of parents and neonatal caregivers is required.
The subsections of the NIPS showing most changes after handling episodes were breathing pattern, followed by facial expression. The subsections where least changes were observed were state of arousal and cry. This may be an unexpected finding for those caregivers not commonly adopting pain scales in their practice. Caregivers need to be made aware of the variety and presentation of pain responses of the infant with VLBW to general caregiving procedures. This information can enable caregivers to monitor and modify practice so as to incorporate adequate pain relieving (both pharmacological and non pharmacological) and pain prevention strategies.
Only seven of the 18 infants observed in this study were sedated; all of these infants were observed at one hospital site. This perhaps indicates that the provision of adequate pain relief for an infant born VLBW receiving neonatal intensive care, as recommended,33 is not being implemented in all NICUs. This finding should be considered in light of the result that the sedated infants had significantly lower pain responses after handling than those infants not sedated, demonstrating the effectiveness of the sedation. Neglecting pain relieving and pain prevention measures may have the effect of continued adverse functional and behavioral sequelae for an infant with VLBW as these measures are thought to have a neuroprotective effect.16,25 Those infants who were sedated were handled less frequently than those who were not. This may partly be the result of the fact that all of the sedated infants were observed at the NICU where there were less handling episodes generally. However it may also indicate that sedated infants require less caregiver handling as they are more settled.
This study observed an average of 53 handling episodes during 24 hours of observation, with the total duration of handling being 2.7 hours. These results are comparable with other studies that have been conducted in various NICUs worldwide.5,34 The most frequent handling procedure observed was repositioning of the infant (mean 20.5). This procedure involved movement or adjustment of a body part but did not involve an actual posture change, ie, supine to prone, suggesting that the handling was primarily aesthetic in nature. This result supports previous research which has observed that a number of handling events in neonatal intensive care appear to be primarily to “tidy up the incubator,”6 thus suggesting the need for caregiver education on the importance of minimizing unnecessary handling with the infant with VLBW in a NICU.
The majority of handling episodes observed (mean 5.5) involved the caregiver approaching the infant abruptly, with approximately half (mean 26) of the handling being of strong intensity. These results highlight that more attention is required on behalf of caregivers in NICUs to modify the approach and intensity of the touch provided during infant handling in order to potentially minimize the pain response. The effects of modification of different aspects of handling and their effect on infants’ pain responses is an area for further investigation.
The results of this study suggest that cluster care and social touch are not practiced as recommended in some NICUs. Just more than half (mean 39.5) of the handling episodes included only one procedure, thus not fulfilling cluster care. The degree of parental contact (mean 5) and the amount of social touch (12.3% of handling episodes) the infant is exposed to is limited. Therefore, the contribution that these aspects of neonatal care may make to both the ameliorating adverse neurodevelopment of an infant born with VLBW22,23,27,28 and to reducing health care costs29,30 will remain unchanged if determined efforts are not made to address them. Additionally, the lack of parental contact and visitation and number of potentially unnecessary handling episodes that are painful and stressful for the infant with VLBW indicates that modern day philosophies are not influencing handling in some NICUs. However, the number and duration of handling episodes did not differ significantly between day and night or between week days and weekends indicating that care in the NICUs studied was evenly distributed, an important component of developmental care.
The proximity of the observers during the study could have influenced the caregiving practices of nurses and parents35 and so limits the generalizability of the results. Additionally, the fact that the two observers were not blinded may have biased the results. Generalizability is also affected as the study was conducted in the UAE, where health care is modernizing. Previous work has compared hospital sites in the Middle East (Beirut) and the United States (California) and found that nursing interventions with infants born VLBW were conducted more frequently in the United States-based nurseries.6 Therefore, the number of handling episodes observed in this study may be smaller in number compared with more developed health care systems. However, further research would be required in the current neonatal climate to establish this. Neither of the two NICUs studied adopted a specific developmental or family intervention approach and so the result can only be applied to NICUs that have not implemented these philosophies again limiting the generalizability of the results.
The sample size of this study was small and so analysis between types of handling and caregiver and their effects on pain may be limited due to the likelihood of a type II statistical error. The small sample also limited analyses of separate aspects of touch such as intensity, approach or location and effects on pain. Future research should investigate this in more detail. This study included infants who were sedated and not sedated in accordance with previous research in this field. However, with a small sample this reduced the strength of the analysis of the infants’ pain responses and limits generalizability.
The main strengths of this study were the detailed documentation of the handling procedures and the analysis of the effects of handling on each subsection of the NIPS Additionally the majority of previous studies have observed the infant over a specific time frame at fixed intervals as compared to this study which observed the infant during a 24-hour period in each hospital on all days of the week providing a more complete picture of care giving in the NICU.
Future studies with increased resources should increase the sample size and thus the duration of the total time of care observed and should consider exclusion of sedated infants. Video recordings would enhance the validity of the observations. Regular research is also essential in NICUs in the future to monitor caregiving practices and to ascertain if handling recommendations are being implemented.
General handling of infants with VLBW in the NICU causes a significant alteration in their pain responses. The pain responses seen are varied with changes in breathing pattern and facial expression the most common. Health care professionals providing neonatal intensive care need to be made aware of the effects of neonatal handling episodes on infants’ pain and pain responses, and take appropriate measures to ensure this is minimized and prevented. These measures may have a neuroprotective effect and may then promote infant development.
Despite recommendations, infants born with VLBW are handled frequently during a 24-hour period and social touch remains infrequent. Handling in NICUs needs to be routinely monitored to ensure unnecessary care giving is minimized. Parents and caregivers need to be educated and supported in providing social touch which may potentially benefit the infant. Neonatal PTs, with their knowledge of touch alongside their working objective of optimizing the neurodevelopment of infants with VLBW, are well placed to play a major role in influencing and monitoring handling practices in NICUs.
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Glossary of Terms
Direct physical contact by any individual during the stated time interval. If an infant was handled and the individual left the side of the incubator but returned within one minute and continued to handle the infant this was counted as a single handling episode if the gap was longer than one minute it was counted as a new and separate episode.
An individual caregiving procedure with a specific aim, eg, nappy (diaper) change, suctioning. More than one procedure could be conducted during a handling episode.
The temporal length of touch from initiation of physical contact by the caregiver to cessation of contact.36 This was recorded using a digital stopwatch.
The area(s) of body contacted. These included the upper and lower extremities and face, neck, or trunk.
The rate of approach to a body surface by the caregiver. Action can be abrupt or gradual as a function of speed or rate of approach to the body.17
The extent of indentation applied to the body surface by the pressure of the caregiver’s touch. Rated as strong, moderate and weak.6
Any procedure requiring penetration of the skin surface or introduction of a foreign object into a body cavity, eg, heel prick, suctioning.
Any procedure requiring direct physical contact with but not penetrating the body surface, eg, stroking, repositioning.
Beneficial contact, stroking or touching, provided to calm or comfort the infant.
Direct physical contact provided other than social touch.