EMPIRICAL STUDIES

doi: 10.1111/j.1471-6712.2010.00784.x

Randomized clinical trial of musical distraction with and without headphones for adolescents immunization pain
lo nsdo ttir RN, MS (Doctoral Candidate)1 and Guru nsdo ttir RN, DrPH (Professor)2,3 n Kristja O f Kristja
1

Dalhousie University and IWK Health Centre, Halifax, NS, Canada, 2Faculty of Nursing, University of Iceland and 3Landspitali-University Childrens Hospital, Reykjav k, Iceland

Scand J Caring Sci; 2011; 25; 1926 Randomized clinical trial of musical distraction with and without headphones for adolescents immunization pain Distraction has shown to be a helpful pain intervention for children; however, few investigations have studied the effectiveness of this method with adolescents. The aim of this study was to evaluate the usefulness of an easy and practical musical distraction in reducing adolescents immunization pain. Furthermore, to examine whether musical distraction techniques (with or without headphones) used inuenced the pain outcome. Hundred and eighteen 14-year-old adolescents, scheduled for polio immunization, participated. Adolescents were randomly assigned to one of three research groups; musical distrac-

tion with headphones (n = 38), musical distraction without headphones (n = 41) and standard care control (n = 39). Results showed adolescents receiving musical distraction were less likely to report pain compared to the control group, controlling for covariates. Comparing musical distraction techniques, eliminating headphone emerged as a signicant predictor of no pain. Results suggest that an easy and practical musical distraction intervention, implemented without headphones, can give some pain relief to adolescents during routine vaccination. Keywords: acute pain, distraction, music, adolescents, children, immunization, needles. Submitted 20 February 2009, Accepted 4 February 2010

Introduction
Injections, especially immunizations, are the most common universal health-related procedures in childhood. Although minor, these health care procedures cause pain and fear in both children and adolescents. It has been estimated that at least 10% of the general population has needle phobia, with the prevalence going up to 22% in a US sample of teenage girls needing prenatal care (1). Despite outward signs of coping with painful medical procedures in childhood, the pain and fear associated with these procedures can have future negative effects on seeking medical care as young adults (2). It is unknown how many adolescents refuse to receive further immunizations based on previous negative experiences as a young child. However, the use of pain intervention during paediatric immunization has been emphasized (3). Building a positive experience around immunization thus can lead to less fear and more positive health care experiences in adulthood.

Correspondence to: lo nsdo ttir, 5850/5980 University Avenue, 8th r Mrs O f Kristja (K8306) Halifax, Nova Scotia, B3K 6R8 Canada. E-mail: [email protected]

Early adolescence is a crucial period during which teens take increasing responsibility for their own health (4), and begin to manage their own pain (5). For minor health-related procedures such as immunization, nonpharmacological, such as distraction can decrease reported pain experience and distress among children (6). Various distraction interventions are available for managing childrens pain and distress related to needles. These include looking through kaleidoscopes (7) or virtual reality glasses (8), blowing bubbles or air (9, 10), watching television (11), listening to music (8, 12, 13) or a combination of distraction techniques (14). However, the use of distraction techniques for adolescents specically during needle pain has received little attention and only few studies have included adolescents as research subjects (8, 14). In clinical settings, music has been found to be a preferred coping strategy by adolescents over other coping methods (15). For nurses working with adolescents in school clinics, music distraction can potentially serve both as a pain intervention and as a coping method adolescents can utilize at home when coping with pain (e.g. headache, muscle ache/pain). Headphones are part of adolescent music culture, and are recommended as a part of music distraction interventions to reduce pain (16, 17). Studies using music distraction for children during a minor painful 19

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. Kristja ttir, G. Kristja ttir O nsdo nsdo tion pain when compared with standard care (control treatment), controlling for covariates (see Fig. 1), and (ii) that musical distraction with headphones is more effective in reducing self-reported immunization pain than musical distraction without headphones, controlling for pain related factors (see Fig. 1).

procedure have all used headphones. To our knowledge, no study has compared whether the use of headphones inuences pain outcome in clinical context. This element could prove to be an important factor when implementing musical distraction as a pain intervention within busy clinical settings.

Theoretical framework
The gate control theory (GCT) provides a theoretical basis for using distraction (18). The analgesic effect produced when using distraction appears to work through the reticular system in the brain stem that can slow down incoming stimuli, including pain. The brain stem may then project inhibitory impulses which help close the gate of transmission to the pain producing impulses (a normal or excessive sensory input may therefore relieve pain) (19). Enlightened by the GCT, Patricia McGraths child pain perception model (20, 21) is respected within nursing (22). This model brings forth the complexity of pain introducing four main factors, i.e. situational, behavioural, emotional and stable factors, unrelated to the pain stimuli, that may inuence childrens acute pain sensation (23). These factors are considered signicant to assess when providing a specic pain treatment as they may, to some extent, inuence its effectiveness (21). These include for example, previous pain experiences, gender, pain coping, emotional coping, experienced control, expected pain during procedure, preprocedural anxiety and preprocedural fear (23, 24) (see Fig. 1). The aim of this study was to examine the effectiveness of an easy and practical pain intervention for reducing adolescents immunization pain sensation. At the same time, we wanted to test whether covariates (i.e. gender, previous pain experiences, pain coping, emotional coping, experienced control, expected pain during the procedure, preprocedural anxiety and preprocedural fear) representing McGraths child pain perception model inuence the effectiveness of the musical distraction intervention (see Fig. 1). The study hypotheses predicts (i) that musical distraction [with(out) headphones] reduces self-reported immuniza-

Method
A randomized three-group experimental design was employed to test the stated hypotheses.

Participants
A target sample of 121 adolescents aged 1315 scheduled to undergo immunization at one of the largest primary schools in Iceland was used. Of these students, 118 agreed to participate and completed the study. The sample size was based on similar studies and an estimate of sample size for testing difference between three means with power of 0.8 and an a = 0.05 (25).

Procedure
The study was approved by the National Bioethics Committee and the Data Protection Authority in Iceland, according to Reg. no. 286/2008 on scientic research within the health sector. Based on these approvals, consent for the study was granted by the Chief Nurse Executive at the health care centre responsible for school health services, as well as the central school authorities and the Educational Service Centre. Adolescents were approached through their school where their classroom teacher introduced the study and distributed the information/consent forms for the parent(s) and adolescents. Willingness to consent in the study did not affect the service offered to the students by the nursing staff. Inclusion criteria included all Icelandic speaking adolescents scheduled for a ninth grade immunization. Adolescents completed a background questionnaire before the immunization day in their classroom, administered by their homeroom teacher. On the immunization day in the health clinic location, they completed a pre and postimmunization questionnaire focusing on pain intensity and distress. It took approximately 10 days to collect data in the classrooms and at the schools health clinic. A table of random numbers was used to randomize into groups, providing each participant with the equal probability of being assigned to either the control or the experimental groups (26). The school nurses were not blinded to the intervention groups, but were blinded to the research hypothesis. The adolescents were informed to which research group they were assigned, while in the health clinic.

Stable factors Gender Previous pain

Behavioural factors Pain coping by music Emotional coping by music

Situational Emotional factors factors Expected Pre-immun. immun. pain anxiety Control Pre-immun. fear

Adolescents immunization pain sensation

Musical distraction [with(out) headphones] intervention

Figure 1 Theoretical frame on factors inuencing adolescents immunization pain sensation (based on Patricia McGraths model with authors approval).

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Trial of musical distraction with(out) headphones Two registered school nurses, both with years of experience in working with school children, performed the injections. The nurses attended the different study groups equally. To limit contamination of effects, only one adolescent at a time came to the clinic for their immunization. As the study setting was a normal clinic, there was regular coming and going of students not participating in the study. These incidences were recorded by researchers and did not cause problems.

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measured using a 10-cm VAS, with a line anchored at one end by the phrase not frightened and 0 and at the other end by the phrase as frightened as possibly imagined being and 10. Behavioural factors. Adolescents coping behaviour was measured by their use of music when in pain and when feeling bad (use vs. not use music). Situational factors. For expected pain during the immunizations, adolescents reported with a 10-cm VAS scale using dual anchors (expect no pain = 0) and (expected as much pain as possible = 10). For internal health locus of control (IHLC), adolescents responded to ten statements using a 5-point scale, describing their level of health control ranging from statements such as: good health is just a matter of luck to good health only depends on what I do for myself and how I behave (coded 2 to )2, indicating positive to negative statements of the items involved) (32). Reliability and validity for the IHLC has been established (33). Adolescents immunization pain intensity. Pain intensity was the primary outcome measure, evaluated immediately after the immunization. For pain intensity, adolescents reported using a 10-cm VAS with anchor phrase no pain and 0 at one end, and at the phrase as painful as possibly imagined being and 10 at the other end. The VAS is a uni-dimensional measure of pain. This measure has widely been applied in paediatric pain studies, and has wellestablished validity and reliability (34).

Measures
The WHO-Euro cross-nation study series of health-related behaviours in school children measurement tools were used in the design of the questionnaires (27). These measures have repeatedly been applied in international large surveys (28). The authors adapted the questionnaire to include additional measures relevant to the context of the current study. All measures were pilot tested. Demographic variables. Age, health and parents cultural background were derived from the self-reported adolescents background questionnaire. Berger and Walkers denition of health was applied; asking adolescents, a yes/ no question whether they had a chronic disease and/or were physically handicapped (29).

Pain related factors (covariates).

Eight covariates represented McGraths four factors in the study theoretical frame (see Fig. 1), as they are believed to affect childrens acute pain experiences. These include, previous pain experiences, gender, pain coping, emotional coping, experienced control, expected procedural pain, preprocedural anxiety and preprocedural fear (23, 24) (see Fig. 1). Stable factors. Adolescent gender was collected through the self-reported background questionnaire. Gender was dummy coded (boys = 1). For previous pain experience, adolescents were asked: How intense was the worst pain you have ever experienced? using a 10-cm visual analogue scale (VAS) with anchored phrase no pain at one end and the worst pain imaginable at the other end. VAS scales have extensively been researched, showing good reliability and validity for children older than 8 years (30). Further, different forms of VAS show a high correlation (31). Emotional factors. Adolescents preimmunization anxiety was measured using a 10-cm VAS with a line anchored at one end by the phrase not anxious and 0 and at the other end by the phrase as anxious as possibly imagined being and 10. Adolescents preimmunization fear was

Pain intervention and immunization procedure

A school nurse prepared the adolescent for the polio immunization and answered any questions and concerns related to the procedure. The nurse also responded to any discomfort or complaints related to the immunization. In line with the nurses standard protocol, one adolescent at a time came to the clinic for immunization. After rubbing alcohol on the injection site, the vaccine was injected into the teens deltoid muscle followed by a plaster. Adolescents could choose the arm to be injected, which usually was their none-dominant hand. In the standard care condition, the school nurses were encouraged to maintain their normal modes of caring, which was to comfort and guide the adolescents verbally. If the adolescents had any questions or concerns prior to the immunization, or discomfort after the immunization, the school nurses responded to these with care. Musical distraction intervention [with(out) headphones]. Distraction or active music listening was the pain intervention in the study. Distraction can be viewed as a cognitive coping strategy, where attention is diverted from a noxious stimulus by passively redirecting the subjects attention or

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. Kristja ttir, G. Kristja ttir O nsdo nsdo intensity, pain coping via music, emotional coping via music, preimmunization anxiety, preimmunization fear, experienced control and expected immunization pain, were included in a logistic regression model with pain outcome, as the dependent variable (Fig. 1). For the logistic regression analysis, all variables were entered in one step, and in nonhierarchical sequence. The dependent variable indicated presence or absence of pain (as determined by self-report). The p-value was set at <0.05 for statistical signicance.

by actively involving the subject in the performance of a distractors task (35). In designing the intervention, therapeutic nursing intervention guidelines, on distraction to relieve pain (17) and music therapy (16), were used. In addition, a music therapist was consulted. The intervention protocol was the same for both intervention groups and included the following: (i) explaining the purpose of the music to the adolescents i.e., to distract and to help them cope during/after the immunization, (ii) asking them to concentrate on and disappear into the music, and continue to do so for a few minutes (23 minutes) before and after the immunization, (iii) creating a sense of control in the adolescents by giving them choice i.e., selecting a CD and controlling the volume setting and (iv) asking those getting musical distraction via headphones to wear them during the immunization, while the other group was asked to listen to the music from the loudspeakers. The music for the study was selected based upon results from a pilot study. Using a hypothetical immunization, six teens (1315 years old) were interviewed showing they preferred top ten chart music to relaxing music during the immunization. These results are in accordance with other studies addressing music preferences by adolescents (36). Acknowledging this, the music used in the study was largely chosen from top 10 charts of the day, with the exception of one relaxing classical CD. In selecting the top ten chart music for the study, advice from a music marketing manager (Skifan), who knew adolescent music preferences, was sought.

Results
Descriptive information
Adolescents participating ranged in age from 13 to 15 (mean: 14, standard deviation 0.18 years) with 63 boys (53.4%) and 55 (46.6%) girls, almost all being Icelandic (97%) and healthy (Table 1). The respondents expected immunization pain was on average 2.78 2.49 cm (range 010). Their preimmunization anxiety was rated on average 3.06 3.03 cm (range 010). Adolescent fear ratings prior to the immunization were on average 1.69 2.35 (range 09.9) (Table 1). F-tests and MannWhitney U-tests found no signicant differences between the three research groups on covariates (i.e. gender, previous pain intensity, pain coping by music, emotional coping by music, experienced control, expected immunization pain intensity, preimmunization anxiety and preimmunization fear), or any of the demographic variables (Table 1). Immunization pain outcome across the sample was on average 0.96 1.40 cm (range 07). Only 23 adolescents (11.9%) rated their pain equal to or higher than 2 cm. The reported immunization pain intensity (VAS 010) among adolescents in the musical distraction group via headphones was on average 1.01 1.48. For the musical distraction group not using headphones, the pain intensity was on average 0.87 1.67, whereas for the controls it was on average 1.00 0.95 (Table 1).

Data analysis
SPSS 17.0 (SPSS Inc., Chicago, IL, USA) was used in all data analyses. Descriptive statistics were used to assess violations of underlying assumptions (i.e. normal distribution, extreme outliers), and missing data was analysed. The three research groups were compared on demographics and covariates with F- and MannWhitney U-tests. Pain intensity scores were low and heavily skewed to the left (towards zero). To compensate for the skewed distribution, pain scores were dichotomized into no pain (00.09 cm) and pain (0.110 cm) categorical variables, enabling the use of multiple logistic regression (37). Logistic regression analysis was employed to assess the effects of musical distraction and model covariates on adolescent immunization pain scores. The intervention variable was coded as a dichotomous variable reecting musical distraction intervention: musical distraction with and without headphones (compared to controls), musical distraction without headphones (compared to music with headphones and controls) and musical distraction with headphones (compared to music without headphones and controls). Apart from the musical distraction variables, eight other independent variables including gender, previous pain

Intervention effects
Entered as single variables, musical distraction (OR = 2.83), preimmunization anxiety (OR = 0.84), preimmunization fear (OR = 0.83) and expected immunization pain (OR = 0.80) were signicant predictors of adolescent immunization pain sensation (Table 2). However, when entered jointly into a nine variable logistic regression analysis, only musical distraction emerged as a signicant predictor of immunization pain sensation (Table 2). For the rst hypothesis, a logistic regression analysis was conducted to assess whether musical distraction (with and without headphones) would predict immunization pain,

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Trial of musical distraction with(out) headphones

Table 1 Descriptive information for study variables by total sample and study groupsa

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Mean (SD) Sample Variables Demographic Age (14 years = 0) Health Chronic disease (n = 0) Handicapped (n = 0) Mothers cultural background (icelandic = 1) Fathers cultural background (icelandic = 1) Pain-related factors (covariates) Stable factors Gender (girls = 0) Previous pain intensity (010) Emotional factors Preimmunization anxiety (010) Preimmunization fear (010) Behavioural factors Pain coping using music (not selected = 0) Emotional coping using music (not selected = 0) Situational factors Expected pain during immunization (010) Control (IHLC) [2 to ()2); 2 = positive] Immunization pain outcome Pain outcome Interval (VAS 010) Dichotomous (pain = 0) Music with headphones Music without headphones Controls

0.03 (0.18) 0.06 0.03 0.96 0.97 (0.24) (0.18) (0.18) (0.16)

0.05 (0.23) 0.03 0.05 0.95 0.97 (0.16) (0.23) (0.23) (0.16)

0.03 (0.16) 0.07 0.02 0.98 1.00 (0.26) (0.16) (0.16) (0.00)

0.03 (0.16) 0.08 0.02 0.97 0.95 (0.27) (0.16) (0.16) (0.22)

0.53 (0.50) 5.79 (2.91) 3.06 (3.03) 1.69 (2.53) 0.48 (0.50) 0.77 (0.42) 2.78 (2.49) 0.25 (0.43)

0.54 (0.51) 5.10 (2.88) 3.50 (3.21) 1.96 (2.35) 0.50 (0.51) 0.76 (0.43) 2.71 (2.37) 0.30 (0.33)

0.56 (0.50) 6.32 (2.70) 2.43 (2.63) 1.30 (2.20) 0.54 (0.50) 0.83 (0.38) 2.53 (2.30) 0.24 (0.44)

0.51 (0.51) 5.90 (3.10) 3.30 (3.20) 1.86 (2.52) 0.41 (0.50) 0.72 (0.46) 3.10 (2.80) 0.21 (0.51)

0.96 (1.40) 0.42 (0.49)

1.01 (1.48) 0.42 (0.50)

0.87 (1.67) 0.56 (0.50)

1.00 (0.95) 0.26 (0.44)

VAS, visual analogue scale; IHLC, internal health locus of control. Statistical difference between groups not found.

Table 2 Logistic regression of musical distraction on pain outcome, without controlling for (crude) and controlling for (adjusted) covariates (n = 118)

Crude OR (95% CI) Musical distraction (control = 0) Gender (girls = 0) Previous pain intensity Pain coping by music (not selected = 0) Emotional coping by music (not selected = 0) Preimmunization anxiety Preimmunization fear Expected immunization pain Control (IHLC; positive = 2) OR, odds ratio; IHLC, internal health locus of control. 2.83 1.49 1.02 0.91 1.04 0.84 0.83 0.80 0.99 (1.226.57) (0.713.13) (0.901.16) (0.440.44) (0.442.50) (0.730.96) (0.690.99) (0.670.95) (0.641.55)

p 0.016 0.289 0.765 0.802 0.925 0.011 0.044 0.011 0.976

Adjusted OR (95% CI) 2.84 1.12 1.11 0.75 1.00 0.87 1.13 0.80 0.76 (1.176.88) (0.452.74) (0.961.29) (0.301.88) (0.332.99) (0.651.16) (0.791.61) (0.571.11) (0.441.30)

p 0.021 0.811 0.170 0.533 0.999 0.335 0.519 0.179 0.318

controlling for covariates. Results showed that the odds of adolescents experiencing no pain during immunization were positively related to musical distraction without headphones 0.021, holding all other variables constant. The odds of an adolescent experiencing no pain during the immunization if receiving musical distraction were approximately 2.8 times higher than those of an adolescent receiving standard nursing care (Table 2).

Entered as single variables, musical distraction without headphones (OR = 2.51), preimmunization anxiety (OR = 0.84), preimmunization fear (OR = 0.83) and expected immunization pain (OR = 0.80) were signicant predictors of adolescent immunization pain sensation (Table 2). However, when entered jointly into the ten variable logistic regression analysis, only musical distraction without headphones emerged as a

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. Kristja ttir, G. Kristja ttir O nsdo nsdo

Table 3 Logistic regression of musical distraction, via headphones and via air, on pain outcome, without controlling for (crude) and controlling for (adjusted) covariates (n = 118)

Crude OR (95% CI) Musical distraction via headphones (control, music via air = 0) Musical distraction via air (control, music via headphone = 0) Gender (girls = 0) Previous pain intensity Pain coping by music (not selected = 0) Emotional coping by music (not selected = 0) Preimmunization anxiety Preimmunization fear Expected immunization pain Control (IHLC; positive = 2) OR, odds ratio; IHLC, internal health locus of control. 1.04 2.51 1.50 1.02 0.91 1.04 0.84 0.83 0.80 0.99 (0.472.27) (1.155.45) (0.713.13) (0.901.16) (0.440.44) (0.4352.50) (0.730.96) (0.690.99) (0.670.95) (0.641.55)

p 0.930 0.020 0.289 0.765 0.802 0.925 0.011 0.044 0.011 0.976

Adjusted OR (95% CI) 2.20 3.58 1.14 1.10 0.73 0.98 0.89 1.13 0.78 0.74 (0.796.12) (1.319.77) (0.462.82) (0.941.28) (0.291.86) (0.332.82) (0.661.20) (0.791.62) (0.561.09) (0.431.28)

p 0.131 0.013 0.773 0.229 0.508 0.971 0.441 0.502 0.139 0.281

signicant predictor of immunization pain sensation (Table 2). For the second hypothesis, a logistic regression analysis was conducted to assess whether musical distraction with and without headphones would predict adolescents immunization pain, with the former being a stronger predictor, controlling for covariates. Musical distraction via headphones was not a signicant predictor (p = 0.131) of adolescents immunization pain, whether controlling for covariates or not (Table 3). Results showed the odds of an adolescent experiencing no pain during immunization were positively related to musical distraction without headphones (p = 0.013), holding all other variables constant. The odds of an adolescent experiencing no pain during the immunization if receiving musical distraction without headphones were approximately 3.6 times higher than those of an adolescent receiving musical distraction with headphones or standard nursing care (Table 3). The percentage of adolescents reporting no pain during the polio immunization was 56% for those in musical distraction group not using headphones, 42% for participants in musical distraction using headphone and 26% for the control group (v2 = 7.64, p = 0.022).

Discussion
The prediction that musical distraction would be associated with reduction in adolescents self-reported immunization pain sensation is supported. These ndings are consistent with several studies of distraction for children and adolescents to reduce pain and/or distress (911, 13, 38), while contradicting others (7, 8, 12, 14). Theoretically, these ndings are in line with the GCT. Accordingly, effective distraction methods are able to keep the pain gate (in the spinal cord) narrow and closed, thus inhibiting pain impulses entering the brain (18). Furthermore, Patricia McGraths model (21) (see Fig. 1 and Table 1) corroborates the pain reducing effect of musical distraction.

Three covariates (expected pain, preimmunization anxiety and preimmunization fear) emerged as single signicant predictors of pain outcome, along with musical distraction (see Table 2). When adjusted for, musical distraction, however, was the only signicant predictor of the pain outcome variable. By controlling for the pain related factors (covariates) suggested by Patricia McGrathss model, musical distraction unfolded in a stronger and signicant intervention effect. The prediction that musical distraction via headphones would be more effective in reducing adolescents selfreported immunization pain compared to the other two groups was not supported. However, results showed that musical distraction without headphones is effective in reducing immunization pain sensation compared to the other two groups. Headphones are commonly used by adolescents and have been recommended when giving musical distraction to reduce pain (16). Also, previous studies have used headphones when applying musical distraction. Therefore, the ineffectiveness of using headphones as part of the music distraction for adolescents immunization pain was unexpected. The adolescents in this study did not seem uncomfortable with using the headphones per se, but they were observed removing the headphones to re-engage with the nurse. The isolation effect of using the headphones may have produced more difculty for adolescents in controlling what was going on during the immunization. The headphones may also have interfered with the adolescents seeking comfort from the nurse administering the immunization. A similar effect of using headphones during musical distraction was detected by Megel et al. (12) while studying 36-year-old children having immunizations. In this study, a stress effect was connected to the fact that the children were unfamiliar with using headphones and the authors suggested that allowing them to choose whether to use headphones or not might help to avoid some of these difculties. Further studies are needed to gauge the effectiveness of these methods.

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Trial of musical distraction with(out) headphones Musical distraction without headphones appears to be a clinically meaningful pain intervention strategy for adolescents, as 56% of adolescents reported no pain during the polio immunization, compared to 26% in the control group. The clinical effectiveness, however, needs to be conrmed in future studies, using the preferred pain interval measures (39). This study has several limitations. Adolescents immunization pain intensity ratings were very low, which is consistent with previous ndings showing low needle pain scores among older children and adolescents (8, 40). It is not uncommon for childrens pain ratings to be skewed towards the no pain end of the measurement scales for needle procedures (e.g. immunization). This is evident both in the paediatric pain literature (8) and the adult pain literature (41). Researchers have compensated for this by dichotomizing the pain variable (8). Thus, to compensate for this skewed distribution, we dichotomized the pain scores into a no pain (00.09 cm) and pain (0.110 cm) categorical variables. This enabled us to use multiple logistic regression (37), but not for example analyses of variance (ANOVA). By dichotomizing the pain outcome variable, we lost information on pain variability. Relevant statistical information was nonetheless gained. In future studies, procedures with stronger pain strength variability should be used (e.g. intravenous canalization or suturing) to facilitate the detection of any variation in the musical distraction intervention. Also, the covariates controlled for were limited by its emphasis on psychological dimensions affecting childrens pain perception. In regards to the nurses, they were blinded to the study hypothesis but not to the intervention groups. Although the nurses were asked to go about as usual during the immunization procedure, and no behavioural differences towards adolescents depending on groups were observed, we cannot rule out bias because of this. Further, the data collection took a few days and was carried out in a busy school health clinic. This made it difcult to control the adolescents comments to one another about the procedure and impossible to rule out the impact of rumours, either positive or negative, on the outcome variables. Also, children and adolescents not participating in the study had to be attended to by the nurses during the study period i.e., because of minor accidents. Such incidents occurred randomly and should not have disrupted one study group more than another. Finally, in reviewing the intervention variables, several adolescents found the music selection to be limited and recommended a greater variety, e.g. by adding music by David Bowie, the Beatles and Nirvana. Thus, a wider choice of music is recommended in future studies, and if possible to allow the adolescents to bring their own music. In conclusion, musical distraction in general and specically used without headphones was a signicant predictor of feeling less pain during polio immunization,

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whereas the use of headphones was not. These ndings suggest that a cost-effective, time-efcient and easy-to-use nonpharmacological intervention may provide some comfort to adolescents during these routine distressing health care procedures. Before using musical distraction with adolescents, health care professionals should evaluate whether headphone use is appropriate and assess their musical preference. Further studies are needed to be able to recommend musical distraction as a routine clinical intervention during painful procedures such as immunization among adolescents.

Author contributions
. Kristja nsdo ttir designed and implemented the study O nsdo ttir supervision (masters thesis). under G. Kristja . Kristja nsdo ttir was responsible for drafting the manuO nsdo ttir script and making critical revisions. G. Kristja participated in revising the manuscript.

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