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2012Heden L, von Essen L. & Ljungman G. (2009). European Journal of Cancer Care 18, 358-363.Randomized intervelntions for needle procedures in children with cancer.

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Heden L, van Essen l.. & Ljungman G. (2009). European Journal of Cancer Care 18, 358-363.Randomized intervel1tions for needle procedures in children with cancer.

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Randomized interventions for needle procedures inchildren with eancer

1. HEDEN, RN, PHD STUDENT, Department of Women's and Children's Health, Uppsala University, Unit forPaediatric Haematology and Oncology, Children's University Hospital, Uppsala, 1. VON ESSEN, PROFESSOR,Department of Public Health and Caring Sciences, Psychosocial oncology, Uppsala University, Uppsala, &.G. LJUNGMAN, MD, PHD, Department of Women's and Children's Health, Uppsala University, Unit for PaediatricHaematology and Oncology, Children's University Hospital, Uppsala, Sweden

HEDl~.N L., vaN ESSEN L. &. LJUNGMAN G. (2009) European Journal of Cancer Care 18, 358-363Randomized interventions for

The aim of this study was to examine whether children experience less fear, distress and pain connected to aroutine needle insertion in an intravenous port when subjected to an intervention: blowing soap bubbles orhaving a heated pillow Ys. standard care.

Twenty-eight children, 2-7 years, cared for at a paediatric oncology unit, undergoing a routine needleinsertion in an intravenous port were included consecutively. All children were subjected to two needleinsertions; at the first they received standard care, and at the second standard care + a randomized intervention.Parents and nurses assessed children's fear, distress and pain on 0-100 mm visual analogue scales.

According to parents' report, children experienced less fear when subjected to intervention vs. standard carereported by parents (P < 0.001). Children also experienced less fear (P < 0.05) and distress (P < 0.05) whensubjected to standard care + blowing soap bubbles vs. standard care (n = 14), and less fear when subjected tostandard care + heated pillow vs. standard care (P < 0.05). Nurses' reports did not show any differences forstandard care + intervention vs. standard care.

Blowing soap bubbles or having a heated pillow is more effective than standard care in reducing children'sfear and distress in needle procedures, according to parents' report.

Keywords: children, cancer, pain.

INTRODUCTION

Pain is a frequentthe often longstanding,

significantandcancer treatment

(Ljungman et al. 1996, 20001. Children with cancer oftenasmention needle procedures

Correspondence address: Lena Heden, Department of Women's and Chil-dren's Health, Uppsala University, Unit for Paediatric Haematology andOncology, Children's University Hospital, 5£-75185 Uppsala, SwedenIe-mail: [email protected]).

Sources of funding: This research was financially supported by the SwedishChildren's Cancer Foundation

Accepted 5 February 2008DO!: lO.1111/j.l365-2354.2008.00939.x

European Joumal of Cancer Care, 2009, 18, 358-363

@ 2008 The AuthorsJournal compilation @ 2008 Blackwell Publishing Ltd

childrenneedle procedures in with cancer

distressing problem with regard to disease and treatment(Kleiber & Harper 1999; Hedstrom et al. 2003). As most ofthe cancer treatment is administered intravenously, manychildren on treatment have an intravenous port for bloodaccess. The port is implanted subcutaneously on thechild's chest and is connected to one of the centrallylocated large veins through a catheter. To obtain venousaccess, a needle is inserted through the skin into the port.The child has to lie on his/her back for a secure insertion.This can be experienced as distressing and, maybe becauseof the proximity to the face, as a threat to the child'sintegrity. Before needle insertion, the skin is numbed withEutectic Mixture of Local Anaesthetics (EMLA@, Astra-Zeneca, Sodertii.lje, Sweden! as standard care in Sweden.Even when EMLA is used, some children experience the

problem during,childrenin

mostthe painful and

needle procedure as painful and frightening (Ljungmanet al. 1996, 2000) and have to be restrained when theneedle is inserted.

It has been shown that parents expect their child toexperience more distress and report higher levels ofanxiety for younger children «5 years) than for olderchildren during painful procedures (Fanurik et al. 2000).Therefore, it appears particularly important to helpyounger children to cope with pain caused by painfulprocedures. Inadequate pain relief initially in a treatmentperiod is related to inadequate pain relief distress anddifficulty to alleviate pain in connection to future painfulprocedures (Weisman et al. 1998). As a consequence, itappears important to offer good pain relief at the beginningof a treatment period containing painful procedures.

According to Kazak et al. (1998) , a combination of phar-macological and psychological interventions is most effec-tive in order to reduce children's distress caused by painfulprocedures. Psychological interventions can be more orless based on distracting tec;hniques. Distraction can bedefined as drawing the attention from the painful andfearful situation. The intention of distraction is to helpchildren cope with distress and pain (Kleiber & Harper1999), and can be achieved by means of, for example,watching a movie, blowing a party blower, blowing soapbubbles or playing with toys. The distraction can be per-formed by the child or by another person, for example, aparent or a nurse (Powers 1999). Different effects of dis-traction techniques aimed at reducing pain and distress inprocedures have been reported in a Cochrane report(Uman et al. 2006).

It can be assumed that distraction techniques might bemore or less effective for a specific child depending on theindividual child's primary coping strategies. In the litera-ture, different coping strategies are described, for example,focusing on the stimulus (attention) or focusing awayfrom the stimulus (distraction) (Fanurik et al. 1993). Inanother study, Bernard et al. similarly suggest the termsapproach and avoidance; approach coping generally refersto a person's tendency to attend a stressor, whereas avoid-ance coping represses, ignores or diverts attention awayfrom the stressor. In addition, Bernard et al. emphasizes

and randomizationFigure 1. Design

process.


Interventions for procedures in children with cancer

the importance of evaluating developmental differences inchildren vs. adults when choosing distraction method(Bernard et al. 2004). An important challenge is to identifythe child's preference of being active or passive in theprocedure situation. Older children «5 years) can alsochoose a distractor of his or her own preference (Windich-Biermeier et al. 2007).

Blowing soap bubbles is an intervention that has beenused to distract children from pain caused by injections(Sparks 20011. In addition, it may also have an effect onbreathing and thus help children relax. In a pilot study, wefound that blowing soap bubbles has an effect on chil-dren's fear, distress and pain when a needle is inserted inthe intravenous port. The results indicate that youngerchildren «4 years) are more easily distracted by blowingsoap bubbles than older children. Blowing soap bubbles isan intervention, which requires active part taking fromthe child. If a child is unable and/or unwilling to activelycooperate in the distraction intervention, a more passivedistraction or touch can also decrease pain (Sparks 2001).Another more passive intervention that has been sparselystudied is distraction by use of a heated pillow. The modeof action may be through distraction, but other mecha-nisms probably also play an important role, for example,thermal sensory input may reduce the pain input, accord-ing to the gate-way theory (Melzack & Wall 1965).

The aim of this study was to examine whether childrenexperience less fear, distress and pain connected to aroutine needle insertion in an intravenous port when sub-jected to (1) an intervention: blowing soap bubbles orhaving a heated pillow in addition to standard care vs.standard care only; and when subjected to (2) blowing soapbubbles vs. heated pillow.

PATIENTS AND METHODS

Design

The study is a randomized controlled trial with parallelgroups in two steps with standard care as baseline value sothat each child becomes his/her own control, see Figure 1.The groups were (1) standard care at the first needle inser-tion and standard care + blowing soap bubbles at the

Needle insertion 1

Standard care (n=28)

Randomization

~Needle insertion 2Standard care + Heated pillow (n=14)

Needle insertion 2Standard care + Soap bubbles (n=14)

359

HEDEN et al.

second needle insertion; and (2) standard care at the firstneedle insertion and standard care + heated pillow at thesecond needle insertion.

We thus wanted to see if a distracting intervention wassuperior to standard care and if there was a differencebetween the two interventions. Because the effect of theintervention might be unspeeific, we randomized to twodifferent types of interventions, one more active (Le.blowing soap bubbles!, and one more passive (Le. heated

pillow!.

Patients

Twenty-eight children (2-7 Yt:ars) with cancer, cared for atthe Unit for Paediatric Haematology and Oncology at theChildren's University Hospital in Uppsala, Sweden, wereincluded consecutively from 2001 to 2003. Exclusion cri-teria were age <2 years or ;:::8 years, severe pain (> 40 on avisual analogue scale, 0-100 mm) of other cause than theneedle insertion, fever >38°, nausea, or previously knownsevere needle phobia with need of pharmacological seda-tion. None of the approached parents declined participa-tion. See Table 1 for a presentation of the participants'background data. All included children had earlier experi-ences of needle insertions.

Instruments

As children 2-7 years old can have difficulties to reporthow much fear, distress and pain they experience, theirparents and the nurses caring for them were asked toassess these variables for the children on 1O0-mm visualanalogue scales. Our research group has previously usedthe visual analogue scale for proxy assessments of chil-dren's fear, distress and pain (Ljungman et a1. 2001). Inaddition, fear was assessed by the first author at the child'sfirst needle insertion in the study, according to thefollowing: no, little, or great fear.

Procedure

The Regional Ethics Review Board at the Faculty of Medi-cine at Uppsala University approved the study. After the

Table 1. Background data of children randomized to blowing soap bubbles and the heated pillow interventions

Age (years)- mean (range)Girls/Boys (11)Diagnosis (111: (leukaemia/CNS tumour/solid tumourTime (months) since diagnosis - mean (range)Anxiety reported by a nurse at the first needle insertion (n):

(No anxiety/Little anxiety/Great anxiety)

360

child and his/her parent had received information aboutthe study, the parent was asked for consent. A randomnumber table was used for the randomization to one of theinterventions. All participating children were subjected totwo needle insertions; at the first they received standardcare, that is, EMLA-cream on the place for the needleinsertion and information according to the usual routines,and at the second standard care and an intervention,blowing soap bubbles or a heated pillow. The same routineand material for needle insertion in the port was usedduring the entire study inclusion period.

During the needle insertion in the standardcare + blowing soap bubbles condition, the children wereencouraged to look at the soap bubbles flying around inthe room. During the needle insertion in the standardcare + heated pillow condition, the children wererequested to 'feel the pleasant, cosy heat' on the place onthe body where the child had chosen to place the heated

pillow.One of the parents present and the nurse responsible for

the needle insertion quantified the child's fear, distressand pain at the needle insertion with visual analoguescales approximately 30 min after the procedure. The timewas chosen in order for parents to have time to, if neces-sary, comfort their child before answering the visualanalogue scales.

Statistical analysis

A clinically significant effect or difference which wouldmotivate a new treatment has in earlier studies been sug-gested to be 13-18 mm for fear, distress and pain on avisual analogue scale (Todd & Funk 1996; Bishai et al.1999; Hee et al. 2003). Accordingly, we set a relevantdifference to 15 mm calculating with standard deviationsof 20 mm, found in an earlier study (Bishai et al. 1999); wewould reach a power of 0.97 and aHa of 0.05 with two-tailed test to demonstrate a difference between interven-tion and standard care with 28 children. Descriptivestatistics was used for means and standard deviations forvisual analogue scale symptom scores and for symptom

toreduction Paired sample t-test was usedscores.examine whether children experience less fear, distress

Blowing soap bubbles n = 14 Heated pillow n = 14

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and pain connected to a routine needle insertion in anintravenous port when subjected to a heated pillow orblowing soap bubbles in addition to standard care vs. stan-dard care. Independent sample t-test was used to examinesymptom reduction for standard care + blowing soapbubbles vs. standard care + heated pillow. The use of para-metric statistics in the analysis of visual analogue scaleresults can be controversial. We therefore perfonned bothparametric and non-parametric tests with similar results.The statistical analyses were perfonned using spss 13.0(spss for Windows, ReI. 13.0.1. 2004. Chicago: SPSS IncJ.The aHa value was set to 0.05.

RESULTS

See Table 2 for a presentation of means, standard devia-tions and symptom reduction for children's fear, distressand pain reported by parents and nurses at first needleinsertion with standard carc, and at second needle inser-tion with standard care + blowing soap bubbles or havinga heated pillow. Children experienced less fear when sub-jected to intervention vs. standard care reported by parents(t = 4.08, d.f. = 27, P < 0.001). Children also experiencedless fear (t = 2.36, d.f. = 13, P < 0.05) and distress (t = 2.28,dJ. = 13, P < 0.05) when subjected to standard care +blowing soap bubbles vs. standard care (n = 14), and lessfear when subjected to standard care + heated pillow vs.standard care (t = 3.400, d.f. = 13, P < 0.05) reported byparents. Neither parents nor nurses reported any differ-ences in symptom reduction for children subjected tostandard care + blowing soap bubbles (n = 14) vs. standardcare + heated pillow (n = 14). Nurses' reports did not show

any significant differences for standard care + interventionvs. standard care.

DISCUSSION

Blowing soap bubbles or having a heated pillow is moreeffective than standard care in reducing children's experi-ence of fear and distress in connection to needle proce-dures, according to parents' report. In the soap bubblegroup there was reduction in fear and distress, and in theheated pillow group, fear was reduced. This is in accor-dance with earlier studies in children with cancer demon-strating decreased distress during painful procedures withcombined pharmacological and psychological interven-tions (e.g. blowing soap bubbles, reading books, breathingexercises) (Kazak et al. 19981 and decreased fear and dis-tress during needle procedures with distraction interven-tinn~ tWindich-Riermeier ,,;t nr ?,O071

Sparks et al. demonstrated decreased pain perceptionwhen healthy pre-school children were distracted by



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blowing soap bubbles. During intramuscular injectionprocedures in that study EMLA was not used (Sparks2001). In our study pain is r(~ported as the least problemduring the needle procedure compared with fear and dis-tress, and there is no significant reduction in pain afterintervention. This may reflect that EMLA takes away thepain or that pain is not the major problem in port needleinsertions.

According to Berde and Wolfe, anxiety and pain areoften impossible to distinguish from each other and thecombination of the two is often referred to as distress(Berde &. Wolfe 2003). In our study, however, parentsreported less fear for children subjected to intervention vs.standard care, which could indicate that the parents wereable to differentiate between fear and pain.

The heated pillow is an intervention that requires noeffort from the child. This may be more suitable for chil-dren who do not want to be distracted (i.e. attendersfapproachers), and perhaps the youngest children who mayhave difficulties carrying out more active interventions.Consequently, active intervl~ntions such as blowing soapbubbles may be more appropriate for distractorsfavoiders.As far as we know, this is the only study showing that useof a heated pillow can reduce children's fear during painful

procedures.It is generally agreed that patients are the best raters of

their experiences Ivon Essen 2004), and self-report is thegold standard (Finley &. McGrath 1998). Unfortunatelyyoung children «6 years) may have problems to describeand discern feelings of fear, distress and pain to evaluate aprocedure (Blount et al. 2006). Where it is not possible toobtain information by self-report, for example, when thepatient is a small child, the use of proxy-report can be analternative (von Essen 2004).

The visual analogue scale self-report method is a reli-able and valid way to assess pain (Scott et al. 1977). Inaddition, it has been suggested that visual analogue scalescan be used to assess other symptoms such as fear anddistress (Yaster et al. 2002). However, reliability and valid-ity for visual analogue scale use to assess fear, distressand pain in proxy assessment has yet to be established

(McGrath 1990).It is known that nurses sometimes underestimate chil-

dren's pain and it has, as a. consequence, been suggestedthat parents should assess their child's pain to secure fornurses' underestimation (Lal et al. 2001 I. However, parentassessments are not altogether consistent either. Cham-bers et al. have shown that parents rate their child's (5-12years) pain during venipunctures higher (Chambers et al.1999) and their child's (7--12 years) post-operative painlower than the child does (Chambers et al. 1998). More-

362

over, Manne et al. have discussed whether parent as wellas nurse assessments of children's pain at least partly mayreflect the assessor's distress (Manne et al. 1992). Whenassessments do not correlate, the question is whichassessment to consider more valid, parents' or nurses'(Blount et al. 2006). In this study parents, but not nurses,reported less fear and distress for children subjected tointervention vs. standard care. This might indicate thatparents are more sensitive to subtle variations in theirchild's experiences of symptoms than nurses are and thatthe closer the relation to the child, the more valid theassessment. Other possible explanations are that nursesfocus on the needle insertion, and may not be able toaccurately observe the child's behaviour, or that parents'reports to a higher degree reflect their own feelingsfexperiences. Our decision to assess children's fear, distressand pain according to parents as well as nurses was basedon the assumption that various informants may identifydifferent aspects of a phenomenon as suggested by others(Manne et al. 1992; Berde &. Wolle, 20031.

Even though the study has a randomized design, thegroups in the two interventions differed on one essentialpoint. According to nurse reports, only two children in thestandard care + heated pillow condition experienced 'greatfear' at the first needle insertion compared with eightchildren in the standard care + blowing soap bubbles con-dition. The reported results of symptom reduction are ananalysis of the individual change after intervention, so thegroup difference with regard to fear is thus controlled.

It could be argued that the decrease in fear between thefirst and second needle insertion according to parentreports is a consequence of children's adaptation to thepainful procedure (i.e. a period effect). This is unlikely, asall children had gone through multiple needle insertionsprevious to participation in this study. Moreover, the lackof a significant decrease in the nurse assessments supportsthe absence of a period effect. A major limitation of thisstudy is the small sample size; however, power is greatenough to show tllat there is a difference betweenintervention and standard care.

CONCLUSIONS AND IMPLICATION

Blowing soap bubbles or having a heated pillow is moreeffective than standard care in reducing children's experi-ence of fear and distress in connection to needle proce.dures, according to parents' reports. The focus in thisstudy is needle insertion in an intravenous port in chil.dren with cancer but the results can probably be general-ized to procedures in children in general. The effect ofblowing soap bubbles or having a heated pillow is inter-


esting, as these interventions are simple and cheapmethods that can be implemented, without significantlyincreasing the workload for the personnel.

ACKNOWLEDGEMENTS

The authors would like to thank the families and the staffat the Unit for Paediatric Haematology and Oncology inUppsala for valuable cooperation.

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