Cignacco. The efficacy of non-pharmacological ....pdf

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Review

The efficacy of non-pharmacological interventions in themanagement of procedural pain in preterm and term neonates

A systematic literature review

Eva Cignacco a,*, Jan P.H. Hamers b, Lilian Stoffel c, Richard A. van Lingen d,Peter Gessler e, Jane McDougall c, Mathias Nelle c

a Department for Obstetrics and Neonatology, Women’s and Children’s Clinic, University Hospital Insel,

Bern, Effingerstr. 102, CH-3010 Bern, Switzerland b University of Maastricht, Section of Nursing Science, Maastricht, The Netherlands

c

Children’s Clinic, University Hospital Insel, Bern, Switzerland d Isala Clinics, Princess Amalia Department of Paediatrics Division of Neonatology, Zwolle, The Netherlandse Children’s University Hospital, Zurich, Switzerland

Received 31 August 2005; received in revised form 4 February 2006; accepted 19 February 2006

Abstract

Background: Neonates in a neonatal intensive care unit are exposed to a high number of painful procedures. Since repeated andsustained pain can have consequences for the neurological and behaviour-oriented development of the newborn, the greatest atten-tion needs to be paid to systematic pain management in neonatology. Non-pharmacological treatment methods are being increas-ingly discussed with regard to pain prevention and relief either alone or in combination with pharmacological treatment.

Aims: To identify effective non-pharmacological interventions with regard to procedural pain in neonates.Methods: A literature search was conducted via the MedLine, CINAHL, Cochrane Library databases and complemented by ahandsearch. The literature search covered the period from 1984 to 2004. Data were extracted according to pre-defined criteria bytwo independent reviewers and methodological quality was assessed.Results: 13 randomised controlled studies and two meta-analyses were taken into consideration with regard to the question of cur-rent nursing practice of non-pharmacological pain management methods. The selected interventions were ‘‘non-nutritive sucking’’,‘‘music’’, ‘‘swaddling’’, ‘‘positioning’’, ‘‘olfactory and multisensorial stimulation’’, ‘‘kangaroo care’’ and ‘‘maternal touch’’. There isevidence that the methods of ’’non-nutritive sucking’’, ‘‘swaddling’’ and ‘‘facilitated tucking’’ do have a pain-alleviating effect onneonates.Conclusions: Some of the non-pharmacological interventions have an evident favourable effect on pulse rate, respiration and oxygensaturation, on the reduction of motor activity, and on the excitation states after invasive measures. However, unambiguous evidenceof this still remains to be presented. Further research should emphasise the use of validated pain assessment instruments for theevaluation of the pain-alleviating effect of non-pharmacological interventions.

2006 European Federation of Chapters of the International Association for the Study of Pain. Published by Elsevier Ltd. Allrights reserved.

Keywords: Newborn; Non-pharmacological pain management; Neonatal nursing; Procedural pain

1090-3801/$32 2006 European Federation of Chapters of the International Association for the Study of Pain. Published by Elsevier Ltd. All rights

reserved.

doi:10.1016/j.ejpain.2006.02.010

* Corresponding author. Tel. +41 31 632 11 15; fax: +41 31 632 11 23.E-mail address: [email protected] (E. Cignacco).

www.EuropeanJournalPain.com

European Journal of Pain xxx (2006) xxx–xxx

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mailto:[email protected]:[email protected]


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1. Introduction

1.1. Problem statement

Intensive care treatment of preterm and sick terminfants in the neonatology unit entails a period of hospi-

talisation which may last from several weeks to severalmonths. These children are exposed to an environmentcharacterised by highly variable, sometimes excessivestimulation (light, noise and activity related to monitorsand respirators as well as medical emergencies), lack of diurnal variation and frequently changing caregivers.Furthermore, neonatal intensive care involves a highnumber of diagnostic and therapeutic procedures whichare associated with pain for the neonates concerned. Ste-vens et al. (1999), for example, described an average of 134 painful procedures within the first two weeks of lifefor each of 124 preterm neonates with a gestational ageof 27–31 weeks. One preterm infant even underwent 766

invasive procedures in the course of the entire hospital-isation period (Porter et al., 1998). Among 151 neonates,an average of 14 ± 4 painful interventions were recordedduring the first 14 days of life within a period of 24 h(Simons et al., 2003). In a study covering 54 neonates,more than 3000 painful interventions were documentedduring their entire hospitalisation period, of which74% involved preterm infants under 31 weeks gestation(Barker and Rutter, 1995). Most of the painful interven-tions included capillary blood sampling by heel stick,followed by endotracheal suctioning. Preliminary inter-mediate results from a study in Switzerland involving

a random sample of the vulnerable group of intubatedpreterm neonates during their first 14 days of lifeshowed a total number of 4092 interventions among11 children alone, 64.8% of these interventions beingrelated to intubated preterm infants below 28 weeks ges-tation. According to this study, every preterm infantexperiences an average of 372 interventions within thefirst 14 days of their life (Cignacco et al., 2005, manu-script in preparation). These studies are restricted tothe description of brief acute pain stimuli. The fact thatneonates in an intensive care unit are also subjected tochronic pain (e.g., in the case of illnesses and abnormal-ities) and post-operative pain must not be disregarded.

The number of painful and distressing events (light,noise, manipulations) can influence the metabolic rateby increasing the demand for oxygen (Ambuel et al.,1992) and be the cause for cerebral oxygenation distur-bances (Gagnon et al., 1999). As a number of studiesshow, repeated and sustained pain can have direct andlong-term consequences on the neurological and behav-iour-oriented development of the neonate (Anand andCarr, 1989; Grunau et al., 1994, 1998, 2001; Gagnonet al., 1999; Oberlander et al., 2000; Anand, 2000; Gru-nau, 2002; Peters et al., 2005). Data from animal modelsconfirmed that prolonged exposure to pain is harmful to

development. It affects the normal development of thenociceptive neural circuits and leads to an altered devel-opment of the pain system, characterised by loweredpain thresholds during later infancy (Anand et al.,1999; Ruda et al., 2000; Bhutta et al., 2001) and bothhypoalgesia after puberty and hyperalgesia in adulthood

(Ren et al., 2004). Therefore, strategies for stress reduc-tion, such as the concept of developmental care (Sizunet al., 2002; Als et al., 1996), and systematic pain man-agement are central issues in neonatal intensive care topromote the wellbeing and unimpeded development of the neonate. In particular, the use of non-pharmacolog-ical interventions is of great importance, since they arebased on nurses’ clinical assessment of pain and canbe carried out by nursing staff without instructions byphysicians. However, pain management in a neonatalintensive care unit (NICU) remains an interdisciplinarytask.

1.2. Pain assessment instruments for neonates

A precondition for an adequate pain treatment proce-dure is the accurate assessment of the pain. Recently, agrowing number of reliable and valid measurement toolsfor neonates have been developed. In the clinical setting,the validated instruments ‘‘Bernese Pain Scale for Neo-nates’’ (Cignacco et al., 2004), the ‘‘Premature InfantPain Profile’’ (Ballantyne et al., 1999) and the ‘‘ComfortScale’’ (Ambuel et al., 1992; Van Dijk et al., 2000) arewidely used. However, in spite of these developments,many conceptual and measurement issues remain. Thus,

the influence of contextual factors on the expression of pain, such as the gestational age and the associatedimmaturity of the central nervous system, as well asthe influence of states of illness and of consciousness(for example, in the case of sedation during mechanicalventilation) has not yet been comprehensively explained.No instruments have been definitively validated withregard to these influences. Although the use of multidi-mensional instruments is recommended for pain assess-ment in neonates (McGrath et al., 1985; Abu-Saad,1990, 1998; Cignacco, 2001), there are reports of eitherno correlation or low correlation (r = 0.3) between phys-iological and behavioural outcomes of pain (Stevens andJohnston, 1994; Barr, 1998). According to these studies,using measures which combine the interpretation of behavioural and physiological responses into a singlescore for assessing the efficacy of pain-alleviating inter-ventions may not reveal the individual effects on eachof the two systems. Such dissociations suggest that phys-iological systems are only loosely coupled to behav-ioural responsive systems (Barr, 1998). This rendersany evaluation of the effectiveness of interventions diffi-cult, which particularly applies to the evaluation of theefficacy of non-pharmacological interventions. Accord-ing to some studies, there was only a reduction in behav-

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ioural indicators, not in physiological ones (Johnstonet al., 2003; Field and Goldson, 1984). The use of mul-tidimensional instruments is therefore under discussion.The validation study of the Bernese Pain Scale for Neo-nates yielded contrary results. The study proved a goodcorrelation (Cronbach’s Alpha r = 0.80) between two

physiological indicators (heart rate and oxygen satura-tion) and seven behavioural indicators (Cignaccoet al., 2004). Consequently, the Bernese Pain Scale forNeonates also appears to be a valid pain assessmentinstrument in the evaluation of non-pharmacologicalinterventions with a more marked effect on behaviouralindicators. With regard to the dissociation describedbetween physiological and behavioural indicators of individual pain assessment instruments, further valida-tion studies are necessary.

1.3. Interventions in pain management

Up to 80–90% of the medications which are usedamong sick preterm and term neonates in an intensivecare unit are either not approved for the illness con-cerned (off-label use), or are administered in a formother than that officially approved (unlicensed use)(Conroy et al., 1999; Roth, 2004). As a rule, their useis based on clinical guidelines. The reticence in system-atic application for routine short interventions can be justified with a view to their long-term effects and possi-ble side-effects (Anand et al., 2004). By contrast, non-pharmacological methods are suitable to counteractprocedural pain because of their short-term efficacy

and good tolerance, and are therefore increasingly beingrecommended for pain prevention and pain manage-ment. In order to achieve optimum efficacy, both phar-macological and non-pharmacological interventionsadditionally require a reduction of external stimuli, suchas loud noise and bright light (Franck and Lawhon,1998; Stevens et al., 2000). The initiation of non-phar-macological treatment is recommended for mild pain(American and Canadian Academy of Pediatrics, 2000;Anand and the International Evidence-Based Groupfor Neonatal Pain, 2001). Although the immature painsystem in preterm infants predisposes them to greaterclinical and behavioural sequelae (Anand, 2000), therehas been little progress in the provision of effective pro-cedural pain management (Anand, 2001; Anand andSelankio, 1996; Stevens, 1996).

The administration of sucrose has been the most fre-quently studied non-pharmacological intervention forthe relief of procedural pain in neonates (Stevenset al., 1997; Blass and Watt, 1999; Kaufmann et al.,2002; Gibbins et al., 2002). The effects of sucrose arethought to be mediated by endogenous opioid pathwaysactivated by sweet taste, and endure after sucrose isorally administered. There is evidence that the combina-tion of sucrose and ‘‘non-nutritive sucking’’ is the most

efficacious intervention for single heel stick (Stevenset al., 2004). However, there was some inconsistencyas to the concentration of sucrose at which it was effec-tive, and therefore the optimum concentration to beused in preterm and/or term infants has not yet beenidentified. There is still little evidence with regard to

the long-term effect of sucrose. In a study by Johnstonet al. (2002), the analgesic effect of sucrose even afterseveral administrations has been confirmed. In the caseof prolonged administration of sucrose, however, theauthors describe a possible risk of impaired neurologicaldevelopment at the corrected age of 40 weeks gestationin preterms of less than 31 weeks gestation. Studiesregarding the real long term effects, i.e., neurologicaloutcome at one year and beyond are not available.

Although there are other non-pharmacological meth-ods for pain relief currently in use in the neonatal set-ting, there is a paucity of data about their efficacy.This stresses the need for further research into the effi-

cacy and safety of non-pharmacological managementof pain in preterm infants.

1.4. Mechanism of non-pharmacological pain

interventions

Non-pharmacological pain intervention is a prophy-lactic and complementary approach to reduce pain(Franck and Lawhon, 1998). It is assumed that non-pharmacological interventions activate the gate controlmechanism (Melzack and Wall, 1965). Some of themlead to an endogenous endorphine dispersal, which

contributes to the modulation of the pain pulse atthe level of the spinal cord, and have the effect of relieving pain. These interventions can also activatethe attention of neonates, distract them from the pain,and thus modify the pain (Bellieni et al., 2001). It ispostulated that they reduce the pain by pre-emptinghypersensitivity (Stevens et al., 2000). However, it islikely that further multiple parallel physiological anal-getic systems are involved. Effective coping strategies,such as ‘‘maternal touch’’, ‘‘non-nutritive sucking’’and ‘‘kangaroo care’’ (Johnston et al., 2003), may elicitactivation of neuropeptides systems, such as cholecys-tokinin. Cholecystokinin is an opioid-modulating sub-stance that promotes stressor adaptability and canachieve an analgetic effect through the potentiation of opioid activity (Hebb et al., 2005). Furthermore,infants are particularly responsive to olfactory cuesemanating from their mothers’ nipple regions (Porterand Winberg, 1999). Familiar odours may also stimu-late the release of cholecystokinin.

1.5. Objective of the literature overview

The aim of this systematic literature review is to gaininsight into the efficacy of non-pharmacological

E. Cignacco et al. / European Journal of Pain xxx (2006) xxx–xxx 3

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interventions in pain management for preterm and termneonates in a neonatal intensive care setting. Theselected interventions, such as ‘‘non-nutritive sucking’’,‘‘music’’, ‘‘swaddling’’, ‘‘positioning’’, ‘‘olfactory andmultisensorial stimulation’’, ‘‘kangaroo care’’ and‘‘maternal touch’’, are all part of current nursing prac-

tice. As the use of sucrose has been reviewed recently(Stevens et al., 2004) in a Cochrane review and judgedto have a high level of evidence, we choose not to inves-tigate this intervention again.

2. Methods

In line with the research objective, a systematic searchwas conducted via the MedLine, CINAHL and Coch-rane Library databases, and also via the Medscape pro-vider. The literature search covered the period from1984 to 2004, focusing on randomised controlled inter-

vention studies and meta-analyses. Since non-pharma-cological interventions are a central issue for thenursing profession, two MESH headings were entered(‘‘Infant, Newborn’’ and ‘‘Neonatal Nursing’’), workingin combination with the following search terms: ‘‘painmanagement’’, ‘‘neonatal pain and comfort’’, ‘‘neonatalpain and nursing intervention’’, ‘‘neonatal pain andnon-nutritive sucking’’, ‘‘neonatal pain and sensorystimulation’’, ‘‘neonatal pain and music’’, ‘‘neonatalpain and facilitated tucking’’ AND ‘‘positioning’’, ‘‘neo-natal pain and kangaroo’’, ‘‘pain prevention and neo-nate’’. Studies which exclusively examined the

administration of sucrose were not included in thisreview since the effect of sucrose alone has been exten-sively studied before and there is sufficient evidenceavailable regarding its efficacy. After examining 89abstracts, 30 studies were analysed in greater detail onthe basis of established inclusion criteria (Table 1). Fur-thermore, a handsearch was carried out in the Bern Uni-versity Library which also included the reference lists of all located articles. The search attempted to identify allrelevant studies in English, German, French and Italian.In total, 13 studies and two meta-analyses were takeninto consideration with regard to the question of non-pharmacological pain management methods amongneonates.

2.1. Quality examination of the studies selected

The quality examination of randomised controlledtrials (RCTs) includes a consensus statement preparedby an expert survey (Verhagen et al., 1998). In this con-text, criteria are determined which allow for qualitative

statements regarding RCTs. Accordingly, importantquality features of the randomisation process are theexplicit determination of inclusion and exclusion crite-ria, the comparability of patients, double-blinding (bothexaminer and patient) and the intention-to-treat analy-sis. In this present study, with the exception of double-blinding, which is not applicable within the frameworkof trials involving neonates, all of these features weretaken into account for the quality examination. Theuse of pain assessment instruments was also examined.To appraise the quality, a numeric scale of 1–10 wasused, 10 representing the best score. The appraisal wasshared between two authors. The independent appraisal

achieved a correlation of Kappa r = 0.613 (see Table 2).The evidence presented by the studies was assigned onthe basis of an existing and generally acknowledged clas-sification (Gray, 1997). The studies selected do exhibitweaknesses with respect to some criteria, which doesnot allow for authoritative statements with regard tothe efficacy of non-pharmacological interventions. Thesedeficiencies are taken into consideration and explainedin the results and discussion sections.

3. Results

3.1. Features of the studies

The studies taken into consideration (Table 2) differwith respect to the variables examined (physiologicaland/or behaviour-oriented parameters), the patients(ventilated and non-ventilated neonates) and the meth-ods of the non-pharmacological interventions. ‘‘Swad-dling’’ of the neonates and ‘‘positioning’’, as well as‘‘non-nutritive sucking’’, are described as the most fre-quently applied methods for pain relief. Eleven studiesexamined the routine intervention ‘‘heel stick’’ and onestudy (Ward-Larson et al., 2004) focused on the relief of pain during endotracheal suctioning. The two

Table 1Inclusion criteria

Randomised controlled trials or meta-analysis German, French, Italian and English articles Articles on non-pharmacological interventions, which are part of current nursing practice (music, kangaroo-care, facilitated tucking, swaddling,

non-nutritive sucking, olfactorial and multisensorial stimulation, positioning, etc.) Articles in which interventions before, during and after a painful stimulus were studied Articles which included preterm and term infants hospitalised in a neonatal intensive care unit up to 44 weeks gestational age Studies with ventilated and not ventilated preterm and term neonates


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meta-analyses (Prasopkittikun and Tilokskulchai, 2003;Shiao et al., 1997) were likewise restricted to the heelstick. The pain response was determined with differentassessment instruments, which were described in themain as valid and reliable.

3.2. Efficacy of non-pharmacological interventions

3.2.1. Non-nutritive and nutritive sucking

‘‘Non-nutritive sucking’’ refers to the placement of apacifier in an infant’s mouth to promote sucking behav-iour without breast or formula milk to provide nutri-tion. As Table 2 shows, the intervention ‘‘non-nutritivesucking’’ achieves a moderate effect on the behaviourof preterm and term neonates, regardless of neonatalcomplications (Field and Goldson, 1984; Corbo et al.,2000). As a result of ‘‘non-nutritive sucking’’, theybecome calmer and more attentive, and a reduction incrying was observed (Field and Goldson, 1984; Corbo

et al., 2000). ‘‘Non-nutritive sucking’’ on a pacifier ora cotton wool stick also resulted in a significant reduc-tion in the pulse rate (Field and Goldson, 1984; Shiaoet al., 1997; Corbo et al., 2000) and seems to be highlyeffective. Interestingly, this effect was not demonstratedamong neonates with neonatal complications (Fieldand Goldson, 1984). It was not possible to provide con-clusive proof of an effect on transcutaneous partial oxy-gen saturation or the respiratory rate (Shiao et al., 1997;Corbo et al., 2000). One meta-analysis confirmed thatthe type of pacifier (shape, material) and the durationof sucking influence the physiological pain indicators

(Shiao et al., 1997). Sucking on a pacifier or a cottonwool stick which had been sprinkled with distilled water,glucose 10%, or sucrose 24% resulted in a reduction inpain response. A statistically significant reduction inpain response was achieved by sucking on a pacifier withdistilled water (Stevens et al., 1999; Bellieni et al., 2001).However, with regard to pain relief, sucking on a paci-fier with glucose 10% was more effective than suckingon a pacifier with distilled water (Bellieni et al., 2001).This difference could not be observed between distilledwater and sucrose 24%. Both interventions seem to behighly effective (Stevens et al., 1999).

3.2.2. Music

A number of studies examined the effects of differentforms of music: music with intrauterine sounds, instru-mental music or a capella singing (Bo and Callaghan,2000; Butt and Kisilevsky, 2000). Regardless of the typeof music, a positive effect on the pain response wasinvariably recorded, such as the regulation and reduc-tion of the pulse rate, a more rapid reversion of physio-logical parameters to the initial values, a rise in oxygensaturation and a reduction in the excitation state.‘‘Music’’ decreased the pain response particularly whencombined with non-nutritive sucking in a sample of neo-

nates from 30 to 41 weeks gestation as shown by the‘‘Neonatal Infant Pain Scale’’ (Bo and Callaghan, 2000).

Butt and Kisilevsky (2000), however, could not iden-tify an effect of instrumental music and a capella singingon the pulse rate of preterm infants below 31 weeks ges-tation. Facial relaxation, was also delayed in this group.

Evidence of a pain-relieving effect achieved by instru-mental music and a capella singing was only confirmedin preterm infants older than 31 weeks gestation, whichwas measured by the ‘‘Neonatal Facial Coding System’’.This study, however, is restricted in its analytical valuebecause of the small randomised sample size (14 neo-nates). The authors of both studies are in agreement that‘‘music’’ should not be provided for longer than 15 minper intervention due to the risk of sensory overload.

3.2.3. Facilitated tucking

‘‘Facilitated tucking’’ (see Picture 1) was tested inthree studies with randomised samples of 30–40 preterm

infants (Corff et al., 1995; Ward-Larson et al., 2004;Huang et al., 2004). The authors describe facilitatedtucking as an effective pain-relieving intervention.‘‘Facilitated tucking’’ leads to a significant reductionin the pulse rate. Time to first quieting and total cryingtime were reduced significantly in comparison to thecontrol group (see Table 2) (Corff et al., 1995). Withregard to oxygen saturation, however, this interventionshowed no effect (Corff et al., 1995; Huang et al.,2004). It is important to mention, that Corff et al.,1995 did not use an objective measurement tool, butbased the assessment on heart rate, oxygen saturation

and sleep/wake state. The other two studies used the‘‘Premature Infant Pain Profile’’ as an outcome measureof pain. Among a group of 40 intubated and ventilatedpreterm neonates between 23 and 32 weeks gestation,‘‘facilitated tucking’’ during endotracheal suctioningachieved significant pain relief (Ward-Larson et al.,2004).

Picture 1.


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3.2.4. Swaddling

‘‘Swaddling’’ involves wrapping the neonates in afabric cloth (see Picture 2). Among 15 preterm infantsaged above 31 weeks gestation, it was found that ‘‘swad-dling’’ after a painful intervention was associated with aclear reduction in the pulse rate (Fearon et al., 1997).

Among preterm infants under 31 weeks gestation, bycontrast, no effect could be demonstrated with this inter-vention. A contradictory result was obtained by Huanget al. (2004), who found in their study of 32 preterminfants that swaddling was even effective, as measuredby the ‘‘Premature Infant Pain Profile’’, for infantsyounger than 31 weeks (Ballantyne et al., 1999). Like-wise, ‘‘swaddling’’ is described as having an effect onoxygen saturation for all age groups (Fearon et al.,1997). During the recovery phase, the preterm neonatesdemonstrated a significantly faster increase in oxygensaturation, and in the process attained stability morerapidly than the control group. Again, however, a con-

trary result was obtained by Huang et al. (2004): neitherduring nor after the intervention was any significanteffect on oxygen saturation recorded. The behaviour-ori-ented indicators, such as facial mimicry, body languageand crying, were attenuated as a result of ‘‘swaddling’’(Fearon et al., 1997; Huang et al., 2004) although, inthe former study, this effect could only be demonstratedin neonates older than 31 weeks gestation. In a meta-analysis with a random sample of 108 term and pretermneonates, a pain-relieving effect was also recorded, theeffect being maintained, interestingly, for a longer timeamong term infants (up to 4 min). Among preterm

infants, the effect was also present but lasted for a signif-icantly shorter time (Prasopkittikun and Tilokskulchai,2003).

3.2.5. Positioning

Laying the neonate in a prone position is a frequentmeasure in everyday practice as it is expected that the

counter-pressure of the mattress will relieve the painbeing experienced. Furthermore it promotes betterbreathing and a decrease of oxygen needed. In a meta-analysis, the non-pharmacological interventions of ‘‘swaddling’’, ‘‘maternal skin contact’’ and ‘‘position-ing’’ were found to have a moderate (mean effect size

0.53, 95% CI = 0.27–0.80) to large (mean effect size0.79, 95% CI = 0.27–0.80) effect as methods of painrelief (Prasopkittikun and Tilokskulchai, 2003). Thefindings suggest that the moderate to large effect of ‘‘positioning’’ continued throughout the poststick per-iod. In contrast, the effects of ‘‘swaddling’’ (in both full-term and preterm neonates) and of ‘‘maternal holdingand touching’’ tended to decrease over time. Grunauet al. (2004) were unable to confirm the effect of theprone position. It was, however, observed that duringthe measurement of the baseline before the painful inter-vention, the prone position was an indication of deepersleep in preterm neonates than in the control group.

Likewise in a further study with 122 very preterm infantswas concluded that the prone position did not have apain-relieving effect (Stevens et al., 1999). The evidencefor the effect of ‘‘positioning’’ remains inconclusive.

3.2.6. Olfactory and multisensorial stimulation

In accordance with study results which showed astress-relieving effect of the smell of breast milk, Goubetet al. (2003) tested the hypothesis that a familiar odourmight be effective in relieving distress associated withpainful stimuli in preterm infants. They tested thepain-relieving effect of a familiar vanillin aroma among

preterm neonates while sampling capillary blood orwhile taking venous blood. In both groups, three inter-ventions were tested: one group was familiarised witha vanillin odour prior to testing and was presented withit during the procedure; the second group was not famil-iarised with vanillin but was presented with it during theprocedure; the third group was neither familiarised norpresented with an odour at all. In the group familiarisedwith the vanillin aroma, pain relief was demonstrated bya significant reduction in facial mimicry and crying, butonly while taking venous blood. While drawing capillaryblood, no effect was observed. This indicates that theolfactory intervention is probably only effective in casesof slight to moderate pain. The authors concluded thatpresenting a purely ‘‘attentional distracter’’ like an unfa-miliar odour did not relieve the pain in newborns. Onlywhen the odour presented was an ‘‘experiential dis-tracter’’ could a pain-relieving effect be achieved. Theyqualified the familiar odour as ‘‘experiential’’ becauseits effect rested on a prior memory of the encounter withthe odour in the incubator. Similar results were obtainedby the testing of ‘‘multisensorial stimulation’’ (Bellieniet al., 2001). ‘‘Multisensorial stimulation’’ addressesthe neonate on a number of different sensory levels: tac-tile, auditory, olfactory and orogustatory. The neonatePicture 2.


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is calmed during, and in particular after, a painful stim-ulus in a tactile manner by massaging his/her back andface. A few drops of a pleasant-smelling oil are spreadonto the hand used for this (orogustatory level). Duringthe massage, the child is also spoken to gently (auditorylevel). Furthermore, the infant is provided with a cotton

wool stick which has been sprinkled with glucose 10% sothat he/she can suck on it (olfactory level). In a study of 17 preterm neonates, the authors were able to describethis intervention as being significantly more pain-reliev-ing than when using distilled water and standard nurs-ing. In particular, this intervention had a positiveeffect on crying, with the multisensorially stimulatedpreterms not expressing any crying reaction. However,Bellieni et al. (2001) specify that the assessment of theintervention of ‘‘multisensorial stimulation’’ was notblinded, which is to be criticised as a clear bias and callsinto question the efficacy of this non-pharmacologicalintervention as described.

3.2.7. Kangaroo care and maternal touch

‘‘Kangaroo care’’ involves the neonate being takenout of the incubator and laid on the bare skin of themother or father. The neonate is covered with towelsso that there is no loss of body temperature. A studyof 74 preterm neonates older than 32 weeks gestationconfirmed that ‘‘kangaroo care’’ produces a reductionin pain response, using the ‘‘Premature Infant PainProfile’’ as a validated pain assessment tool (Johnstonet al., 2003). The ‘‘kangaroo care’’ intervention showeda significant reduction in pain response in comparison

with the controls at 30, 60 and 90 s after the painfulprocedure. Heart rate and oxygen saturation were sim-ilar in both groups, but the facial activity as an indica-tor of pain being experienced was on average 20%more marked in the control group. One meta-analysis(Prasopkittikun and Tilokskulchai, 2003) describedthe greatest pain-relieving effect occurring with ‘‘mater-nal calming’’ rather than with ‘‘swaddling’’ and ‘‘posi-tioning’’, but the effect dropped off more rapidly incomparison with the other two interventions, where itwas sustained over 4–5 min. Pain relief was onlydescribed for term neonates; preterm neonates hadnot been taken into consideration in the studies cov-ered by the meta-analysis. There are no results at allfor preterm neonates below the gestational age of 32weeks.

4. Discussion

The present systematic literature review provides evi-dence that non-pharmacological interventions do have apain-relieving effect among preterm and term neonates.The results indicate that non-pharmacological methodsmitigate both physiological and behaviour-oriented

reactions. In particular, ‘‘non-nutritive sucking’’, ‘‘swad-dling’’ and ‘‘facilitated tucking’’ seem to have an evidentpain-relieving effect. A considerable limitation concern-ing the verification of efficacy is the fact that all thenon-pharmacological measures discussed were testedexclusively with one-off painful procedural interven-

tions. Neonates in a neonatal intensive care unit are subjected to a large number of painful stimuli, but itremains unclear whether the non-pharmacologicalmethods described also have a beneficial effect on anypossible long-term consequences of prolonged exposureto pain. Unfortunately, there are no studies available onthis subject.

The influence of contextual factors (gestational age,state of illness, state of consciousness) is still a matterof controversy. Butt and Kisilevsky (2000) and Fearonet al. (1997) were able to determine the pain-relievingeffect of music and swaddling exclusively among neo-nates of more than 31 weeks gestation. For preterm

neonates younger than 31 weeks, these interventionsfor pain relief only had an effect on oxygen saturationbut not on the behaviour of the neonates. Both studiesare limited in their analytical value because of theirsmall sample sizes (14 and 15 neonates, respectively).Prasopkittikun and Tilokskulchai (2003) found a rapidrecovery phase in swaddled preterm and term neonates,the preterm neonates being older than 31 weeks gesta-tion. The pain-relieving effect was, however, observedto last longer among term neonates than among pre-term infants. Both ‘‘olfactory and multisensorial stimu-lation’’ achieve pain relief regardless of the infants’

gestational age. Bellieni et al. (2001) describe significantpain relief after exposure to pain. These results must beinterpreted with caution, however, due to the method-ological deficits. In addition, the neonates’ state of health is described as an influencing variable; thenon-pharmacological intervention of ‘‘non-nutritivesucking’’ achieved an effect among healthy pretermneonates only, not among sick neonates (Field andGoldson, 1984). For the latter group, changes wereonly shown in their behaviour (facial mimicry, bodylanguage), but not in pulse rate, respiration or oxygensaturation. Stevens et al. (1999) were unable, however,to demonstrate any difference in pain expression eitheramong extremely preterm neonates or among sick pre-term infants in comparison with healthy and olderones. Sucking on a pacifier with distilled water or withglucose 10% attained a pain-relieving effect in all theneonates in this study. By analysing 10 studies(n = 281), Shiao et al. (1997) were able to confirm asignificant effect of ‘‘non-nutritive sucking’’ in all thepreterm and term neonates examined.

Among the highly vulnerable group of intubatedpreterm neonates with a restricted state of consciousnesscaused by sedatives, ‘‘facilitated tucking’’ achieved aperceptible pain-relieving effect with regard to


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