Applied Nursing Research 33 (2017) 164–168
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Effects of music therapy and distraction cards on pain relief during phlebotomy in children Diler Aydin, PhD, RN a,⁎, Nejla Canbulat Sahiner, PhD, RN b a b
Bandirma Onyedi Eylul University Faculty of Health Sciences, Department of Pediatric Nursing, Bandirma, Turkey Karamanoglu Mehmetbey University, School of Health, Department of Pediatric Nursing, Karaman, Turkey
a r t i c l e
i n f o
Article history: Received 2 April 2016 Revised 15 November 2016 Accepted 19 November 2016 Keywords: Distraction cards Music therapy Pain management Phlebotomy Procedural pain
a b s t r a c t Aim: To investigate three different distraction methods (distraction cards, listening to music, and distraction cards + music) on pain and anxiety relief in children during phlebotomy. Methods: This study was a prospective, randomized, controlled trial. The sample consisted of children aged 7 to 12 years who required blood tests. The children were randomized into four groups, distraction cards, music, distraction cards + music, and controls. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers, and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale. Results: Two hundred children (mean age: 9.01 ± 2.35 years) were included. No difference was found between the groups in the self, parent, and observer reported procedural pain levels (p = 0.72, p = 0.23, p = 0.15, respectively). Furthermore, no significant differences were observed between groups in procedural child anxiety levels according to the parents and observer (p = 0.092, p = 0.096, respectively). Conclusions: Pain and anxiety relief was seen in all three methods during phlebotomy; however, no statistically significant difference was observed. © 2016 Elsevier Inc. All rights reserved.
1. Introduction The International Association for the Study of Pain (IASP) described pain as an unpleasant sensory and emotional state and behavior that originates from any region of the body, depends on existing or possible tissue damage or can be identified with this damage, and is affected by past experiences of the individual (IASP, 1994; Abd El-Gawad & Elsayed, 2015). Pain is first experienced in childhood and its experience is very influential in a child's life (Inal & Canbulat, 2015). Procedures with needles constitute a substantial part of early exposure to pain (Canbulat, Inal, & Sonmezer, 2014; Uman et al., 2013). Individuals are exposed to many painful procedures during diagnosis, treatment and follow-up processes from the first moments of their lives in neonatal period and later in childhood. Children in hospitals frequently undergo painful medical procedures such as phlebotomy, injections, and vaccinations,
⁎ Corresponding author at: Bandirma Onyedi Eylul University Faculty of Health Sciences, 10200 Bandirma/Balikesir, Turkey. E-mail addresses:
[email protected] (D. Aydin),
[email protected] (N.C. Sahiner).
http://dx.doi.org/10.1016/j.apnr.2016.11.011 0897-1897/© 2016 Elsevier Inc. All rights reserved.
which are sensed as frightening by children (Pillai Riddell et al., 2011; Uman et al., 2013; Canbulat et al., 2014; Inal & Canbulat, 2015; Schreiber et al., 2015). Most of the time, these fears lead to reluctance in children and parents towards procedures such as vaccination and phlebotomy and affect children's future experience of treatment and care. Therefore, use of effective methods of pain relief is very important during phlebotomy procedures in children. To this end, the American Academy of Pediatrics (AAP) and American Pain Society (APS) recommend minimizing and relieving pain and stress in minor procedures such as vascular access (American Academy of Pediatrics - American Pain Society (AAP-APS), 2001). Therefore, pharmacologic and non-pharmacologic methods are adopted for reducing pain during medical procedures (Pillai Riddell et al., 2011; Inal & Canbulat, 2015). However, pharmacologic methods such as local anesthetic are expensive and have the effect of reducing the success of vascular access (Buckley & Benfield, 1993). In recent years, nonpharmacologic methods, such as using distraction cards, balloon inflation, squeezing a soft ball and audiovisual techniques, have become the preferred methods because they are noninvasive, cost effective, and reliable, in addition to having no adverse effects (Srouji, Ratnapalan, & Schneeweiss, 2010). Non-pharmacologic methods used in children have been shown to provide substantial acute pain
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management during painful procedures (Pillai Riddell et al., 2011). The benefits of using non-pharmacologic methods include decreased pain, distress, and anxiety, as reported by the parent, child, and/or observer (Wente, 2013). In pain control in children, supportive, cognitive/behavioral, and physical non-pharmacologic methods are used (Srouji et al., 2010; Inal & Canbulat, 2015). Supportive methods include techniques such as watching videos, reading books, having the family stay with the child during the painful procedure; physical methods include techniques such as touching, positioning, massage, hot and cold applications; and cognitive/behavioral methods include techniques such as relaxing and distraction. Distraction is a commonly used method by parents and healthcare professionals to help reduce pain and anxiety during painful procedures (Koller & Goldman, 2012). The use of distraction cards has recently been shown to be beneficial in pain control during phlebotomy (Inal & Kelleci, 2012; Canbulat et al., 2014; Sahiner & Bal, 2015). Music therapy is another method used by nurses to relieve pain and anxiety (Klassen, Liang, Tjosvold, Klassen, & Hartling, 2008; Balan, Bavdekar, & Jadhav, 2009; Kirby, Oliva, & Sahler, 2010; Augustine & Umarani, 2013). This study aimed to compare the effect of distraction by using distraction cards (Flippits; MMJ Labs LLC, Atlanta, GA, USA) and music to reduce procedural pain and anxiety during phlebotomy in children aged between 7 and 12 years. 1.1. Study hypotheses
Hypotheses 0. Use of music therapy, distraction cards and both of them together during phlebotomy do not relieve pain and anxiety in children. Hypothesis 1. Music therapy during phlebotomy relieves pain and anxiety in children. Hypothesis 2. Use of distraction cards during phlebotomy relieves pain and anxiety in children. Hypothesis 3. Music therapy and distraction cards used together during phlebotomy relieves pain and anxiety in children.
2. Materials and methods This study was conducted at the phlebotomy station of the Bandirma State Hospital, Turkey between July 1st and September 20th, 2015. It was designed as a prospective randomized clinical trial that evaluated and compared the effects of music, distraction cards, and music and distraction cards combined on procedural pain and anxiety levels of children during phlebotomy. 2.1. Setting and sample The study population comprised children aged between 7 and 12 years who presented to the children's phlebotomy station of Bandirma State Hospital. The study sample constituted 200 randomly selected children who met the selection criteria. Inclusion criteria were being aged 7–12 years and requiring blood tests. Children were excluded if they were neuro-developmentally delayed, had verbal difficulties, hearing or visual impairments, used analgesics within the last 6 h, or if they had a history of syncope due to blood sampling and children who could not phlebotomy are not included in the study. A power analysis was performed to determine a sample size capable of detecting a reduction of about 10% in the phlebotomy response (e.g. anxiety, pain), which would be seen with a frequency of 90% with a confidence level of 95%; the sample was determined to require at least 200 participants (Canbulat et al., 2014; Inal & Kelleci, 2012). The children were randomized into four groups: music (n = 50), distraction cards
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(n = 50), music + distraction cards (n = 50), and the control group (n = 50) (Fig. 1). Numbers from 1 to 200 were randomly distributed to the 4 groups with no number repetition using a computer program in order to determine which child would be in which group. All data were obtained through face-to-face interviews with the children, their parents, and the observer after the procedure. The phlebotomy process took an average of 3 min (range, 1–5 min). 2.2. Measurement The study data were obtained using the “Child and Family Information Form,” “Wong-Baker FACES (WB-FACES) pain rating scale,” “Children's Fear Scale (CFS),” distraction cards (Flippits; MMJ Labs LLC, Atlanta, GA, USA), a tablet personal computer (pc). 2.2.1. Child and family information form This form was consisted of questions about the socio-demographic characteristics of the child and their previous phlebotomy history. 2.2.2. Distraction cards The distraction cards (Flippits1, MMJ Labs, Atlanta, Georgia, USA) consisted of 5 × 8 cm visual cards with various pictures and shapes. The children were given the opportunity to examine the cards, and then the researcher asked the children about what they could see on the cards. Distraction with the cards began immediately prior to phlebotomy and continued until the procedure had been completed. The instrument was translated by an expert who is fluent in Turkish and English because the children were not native English speakers. 2.2.3. Music with tablet PC During phlebotomy process, the children and were asked to choose one of 20 Turkish pop fast songs stored in a tablet pc, which was then played throughout the phlebotomy process. 2.2.4. Music + distraction cards group Distraction cards + music were applied together during phlebotomy. During phlebotomy process, the children and were asked to choose one of song stored in a tablet pc and music is playing the researcher asked the children about what they could see on the cards. 2.2.5. Control group The children in this group were allowed to keep their family nearby. The routine blood taking procedure was conducted. 2.2.6. Wong-Baker FACES (WB-FACES) pain rating scale Pain levels were assessed using self-reports, in addition to parent and observer reports, with the Wong-Baker FACES (WB-FACES) pain rating scale after procedure. The WB-FACES scale is a 0 to 10 scale. Six illustrated faces on the cards show a range of emotions from a smiling face (0: very happy/no pain) to a crying face (10: extreme pain) (Hockenberry & Wilson, 2009). 2.2.7. Children's Fear Scale (CFS) The CFS was used to evaluate the children's level of anxiety. The CFS is a 0 to 4 scale that shows five cartoon faces ranging from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety) (McMurtry, Noel, Chambers, & McGrath, 2011). Pre-procedural and procedural anxiety was evaluated for all children by the parents and the researchers. 2.3. Data collection Two volunteer nurses with a minimum of 5 years' experience in pediatric patient care and phlebotomy were trained for and assisted in the conduct of the study. The nurses had no conflict of interest. A pediatrician made the clinical decision for phlebotomy. Patient demographics
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Enrollment
Did not accept to participate (n=0)
Offered to participate
Volunteers assesed for Eligibility (n=200)
Randomization (n=200)
Group 1 Music group (n=50)
Analized (n=50) Excluded from analysis
Allocation Group 2 Group 3 Distraction Cards Music + group (n=50) Distraction Cards group (n=50) Analysis
Group 4 Control group (n=50) No intervention
Analized Analized Analysis Analized Analysis (n=50) (n=50) (n=50) Excluded Excluded Excluded from analysis from analysis from analysis Fig. 1. Diagram showing the flow of participants.
were collected using the self-report forms, which included medical history, recent analgesic use, and body mass index (BMI). Before preprocedural children's height and weight were make measurements by researcher. Prior to randomization, the researcher read a standardized description of the pain and anxiety tools to the parents and children, both of whom acknowledged that they understood how to complete the measurement tasks. The first nurse, who functioned as an observer, evaluated the preprocedural and procedural anxiety and pain for each child using the 0–4 CFS scale for anxiety and the 0–10 WB-FACES scale for pain. The second nurse performed all phlebotomy procedures. The children's anxiety levels were subsequently reviewed by the parents and observers. A total of 200 children were randomized using a computer-generated table of random numbers into four groups of 50. After the group assignment, the children and their parents went to the phlebotomy station to undergo phlebotomy in sessions held between 8:00–12:00 AM and 12:00–16:00 PM and performed using a 5 mL injector and a 22 G needle. The same nurse conducted the distraction cards for all children. All parents stayed with their children in the phlebotomy station. The distraction cards were used continuously prior to and during phlebotomy. The children's pain levels were assessed post-procedure using the same method used with anxiety levels. After the procedure, the children's pain levels were assessed by self-report and by parents' and the observer's report. Distraction cards + music were applied together during phlebotomy. 2.4. Data analysis All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS Inc., Chicago, Illinois, USA) version 21.0 for Windows. Baseline characteristics among the groups and all parametric data were analyzed using the Chi-square test and Student's ttest. Parametric data such as the level of pain in children was compared with one-way analysis of variance. Statistical significance was set at p b 0.05. 2.5. Ethical consideration The study was approved by the ethics committee of Balikesir University Balikesir Medical Faculty, Balikesir, Turkey (ethics approval number
2014/86, December 26th, 2014, Balikesir, Turkey). The aim and method of study were explained to the children and their parents. They were also notified that they could leave the study at any time without having to explain their reasons. 3. Results 3.1. Comparison of the groups' characteristics Two hundred [84 (42%) girls and 116 (58%) boys] were included in the present study. The mean age of the children was 9.01 ± 2.35 years (range, 7–12 years). The children were randomized into 4 groups, distraction cards (n = 50), music (n = 50), distraction cards + music (n = 50), and the control (n = 50) group. The characteristics of children are presented in Table 1. Age, sex, body mass index (BMI), preprocedural anxiety levels of children were similar among the four groups. There were no significant differences among pre-procedural anxiety levels of the study groups in terms of self, parent, and observer reported levels (p = 0.218, p = 0.080, and p = 0.291, respectively). 3.2. Comparison of pain levels The pain level evaluation of the study groups is provided in Table 2. no difference was found between the groups for self, parent and observer reported procedural pain levels (p = 0.72, p = 0.232, p = 0.157, respectively). Self-, parent- and observer reported procedural pain levels were determined high in the control group (mean ± standard deviation; 4.16 ± 4.42, 4.04 ± 4.49, 4.12 ± 4.37, respectively) however, no statistically significant difference was found (p N 0.05). 3.3. Comparison of anxiety levels Procedural anxiety levels of the study groups are presented in Table 3. No significant difference between the procedural child anxiety levels was reported by the parent and observer groups (p = 0.092, p = 0.096 respectively). In the control group, parents and observers reported that anxiety levels were high (mean ± standard deviation; 1.92 ± 1.68, 1.90 ± 1.60, respectively) however, no statistically significant difference was found (p N 0.05).
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Table 1 Baseline characteristics and pre-procedural anxiety scores of the study groups.
Gender Female Male
Age BMI Pre-procedural anxiety levels Self-reported Parent-reported Observer-reported
Distraction card group (n = 50)
Music group (n = 50)
Distraction cards + music group (n = 50)
Control group (n = 50)
χ2
p
22 (44) 28 (56)
22 (44) 28 (56)
16 (32) 34 (68)
24 (48) 26 (52)
0.399
2.956
Distraction card group (n = 50)
Music group (n = 50)
Control group (n = 50)
F
p
9.04 ± 2.3 18.11 ± 4.2
8.68 ± 2.2 18.15 ± 4.9
Distraction cards + music group (n = 50) 9.10 ± 2.1 18.54 ± 4.4
9.20 ± 2.6 16.66 ± 3.9
0.457 1.739
0.712 0.160
1.10 ± 0.50 1.54 ± 1.34 1.90 ± 1.18
1.56 ± 1.45 1.58 ± 1.42 1.72 ± 1.35
1.20 ± 1.19 2.00 ± 1.41 2.02 ± 1.20
1.24 ± 1.22 2.18 ± 1.68 2.22 ± 1.52
1.492 2.284 1.256
0.218 0.080 0.291
Data are represented as number (percentage) or mean ± standard deviation, where appropriate. BMI: Body Mass Index.
4. Discussion It is very important to reduce or relieve pain in children during medical procedures such as phlebotomy, vaccine applications, and injections because poor pain management causes the child and the parent to feel anxious, which may generate long-term adverse outcomes (Po' et al., 2012; Schreiber et al., 2015; Bahorski et al., 2015). The American Society for Pain Management Nursing recommends that optimal pain control before and during painful procedures needs to be provided (Czarnecki et al., 2011). In recent years, non-pharmacologic and distraction methods in particularly have been frequently used in pain management during medical procedures such as phlebotomy (Uman et al., 2013). There is strong evidence that distraction is effective in reducing pain and distress that children experience during needle procedures (Uman et al., 2013). Numerous studies have reported the effectiveness of a variety of distraction methods used by parents and healthcare professionals to relieve medical procedure-related pain and anxiety, and have been found effective (Inal & Kelleci, 2012; Guducu, Celebioglu, & Kuçukoglu, 2009; Abd El-Gawad & Elsayed, 2015; Karakaya & Gozen, 2015; Meiri, Ankri, Hamad-Saied, Konopnicki, & Pillar, 2015; Mutlu & Balcı, 2015). Recently, Inal and Kelleci (2012), Canbulat et al. (2014), and Sahiner and Bal (2015) demonstrated that distraction cards (Flippits) were very effective in reducing procedural pain and anxiety in children during phlebotomy. In our study, similar to study results in the literature, we found that pain and anxiety levels of the test groups, distraction cards and distraction cards + music in particular, were substantially lower than the control group; however, no statistically difference was detected. It has been specified in various studies in the literature that listening to music during medical procedures reduces pain, anxiety, and aggressive behaviors (Klassen et al., 2008; Srouji et al., 2010; Kristjansdottir & Kristjansdottir, 2011; Inal & Canbulat, 2015). In the study of Sahiner and Bal (2015), which was executed with 120 randomly chosen children aged 6–12 years, it was determined that pain and anxiety levels were reduced in the group in which distraction cards were used and subsequently in the group that listened to music from animated movies. In the study of Augustine and Umarani (2013), it was determined that the pain levels of children who underwent hospital treatment were significantly reduced when they
listened to Indian classical music during medical procedures (e.g. phlebotomy, injection). Kristjansdottir and Kristjansdottir (2011) played different music recitals during polio vaccination to 128 adolescents in a randomized, controlled study. In their three-group study, while undergoing vaccination the first group listened to music with earphones, the second group listened to music in the environment without earphones, and the third group received no distraction. They observed that pain scores of the groups that listened to music were significantly lower than the control group; the lowest pain score was in the group that listened to music with earphones. Hartling et al. (2013) reported that listening to music was effective in 42 children aged 3–11 years during IV cannulation in pain and anxiety level reduction. Although there are studies in the literature showing that music therapy during medical procedures has a positive effect, other studies report that the effects were not clearly determined. Balan et al. (2009) compared the comparative efficacy of local anesthetic cream, Indian classical instrumental music, and placebo in reducing pain in children due to venipuncture. The results showed that pain experienced during venipuncture was significantly reduced using Eutectic Mixture of Local Anesthetics (EMLA) or Indian classical instrumental music. Press et al. (2003) examined the effect of music in pain reduction during blood collection from children aged 6 to 16 years in the emergency department and found no significant differences compared with the control group. Singh (2012) reported on 90 children in whom distraction with toys and music therapy were used. The children were divided into 3 groups during vaccine applications. It was reported that distraction with toys was significantly more effective than music therapy. Similar to the literature, pain and anxiety scores were determined lower in our study; however, no statistically significance was found. A similarity was found for the studies of Press et al. (2003), Singh (2012) and Balan et al. (2009) in terms of no significance between pre-application and post-application pain levels for children who listened to music. 5. Conclusions Distraction using distraction cards, music, and distraction cards + music combined during phlebotomy reduced pain and anxiety levels, but the results were not statistically significantly different. Music
Table 2 Comparison of procedural pain scores of the study groups. Procedural pain scores according to WB-FACES
Distraction card group (n = 50)
Music group (n = 50)
Distraction cards + music group (n = 50)
Control group (n = 50)
F
p
Self-reported Parent-reported Observer-reported
2.60 ± 3.59 2.88 ± 3.64 2.68 ± 3.62
2.60 ± 3.55 3.08 ± 3.68 3.20 ± 3.40
2.36 ± 3.58 2.52 ± 3.40 2.64 ± 3.19
4.16 ± 4.42 4.04 ± 4.49 4.12 ± 4.37
2.364 1.440 1.754
0.072 0.232 0.157
Data are represented as mean ± standard deviation. WB-FACES, Wong Baker Faces.
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Table 3 Comparison of procedural anxiety scores of the study groups. Procedural anxiety scores
Distraction card group (n = 50)
Music group (n = 50)
Distraction cards + music group (n = 50)
Control group (n = 50)
F
p
Parent-reported Observer-reported
1.26 ± 1.46 1.26 ± 1.42
1.46 ± 1.34 1.46 ± 1.38
1.26 ± 1.44 1.28 ± 1.30
1.92 ± 1.68 1.90 ± 1.60
2.181 2.140
0.092 0.096
Data are represented as mean ± standard deviation.
therapy and distraction cards used together was found to have no effect on pain and anxiety experienced by the child. But the effects of music and distraction cards observed during short-term painful procedures such as phlebotomy and vascular access should be supported through further evidence-based studies. In addition, nurses should be aware of the harmful effects of procedural pain and anxiety in children, should consider the use of distraction methods, and have knowledge about different non-pharmacologic methods that may reduce the impact of procedural pain. Conflicts of interest The authors do not have any conflict of interest to declare. Acknowledgements The authors thank the children and their parents who agreed to participate in this study for their effort and contribution. References Abd El-Gawad, S. M., & Elsayed, L. A. (2015). Effect of interactive distraction versus cutaneous stimulation for venipuncture pain relief in school age children. Journal of Nursing Education and Practice, 5(4), 32–40. http://dx.doi.org/10.5430/jnep.v5n4p32. American Academy of Pediatrics - American Pain Society (AAP-APS) (2001). The assessment and management of acute pain in ınfants, children, and adolescents. Pediatrics, 108, 793–797. Available at: http://pediatrics.aappublications.org/content/108/3/793. full.html (accessed September 01, 2015). Augustine, A. A., & Umarani, J. (2013). Effect of music therapy in reducing invasive procedural pain — A quası experimental study. International Journal of Recent Scientific Research, 4(5), 553–556. Bahorski, J. S., Hauber, R. P., Hanks, C., Johnson, M., Mundy, K., Ranner, D., et al. (2015). Mitigating procedural pain during venipuncture in a pediatric population: A randomized factorial study. International Journal of Nursing Studies, 52(10), 1553–1564. http://dx.doi.org/10.1016/j.ijnurstu.2015.05.014. Balan, R., Bavdekar, S. B., & Jadhav, S. (2009). Can Indian classical instrumental music reduce pain felt during venipuncture? Indian Journal of Pediatrics, 76(5), 469–473. http://dx.doi.org/10.1007/s12098-009-0089-y. Buckley, M. M., & Benfield, P. (1993). Eutectic lidocaine/prilocaine cream. A review of the topical anaesthetic/analgesic efficacy of a eutectic mixture of local anaesthetics (EMLA). Drugs, 46(1), 126–151. Canbulat, N., Inal, S., & Sonmezer, H. (2014). Efficacy of distraction methods on procedural pain and anxiety by applying distraction cards and kaleidoscope in children. Asian Nursing Research, 8, 23–28. http://dx.doi.org/10.1016/j.anr.2013.12.001. Czarnecki, M. L., Turner, H., Collins, P. M., Doellman, D., Wrona, S., & Reynolds, J. (2011). Procedural pain management: A position statement with clinical practice recommendations. Pain Management Nursing, 12(2), 95–111. http://dx.doi.org/10.1016/j.pmn. 2011.02.003. Guducu, T. F., Celebioglu, A., & Kuçukoglu, S. (2009). Turkish children loved distraction: Using kaleidoscope to reduce perceived pain during venipuncture. Journal of Clinical Nursing, 18, 2180–2186. http://dx.doi.org/10.1111/j.1365-2702.2008.02775.x. Hartling, L., Newton, A. S., Liang, Y., Jou, H., Hewson, K., Klassen, T. P., et al. (2013). Music to reduce pain and distress in the pediatric emergency department: A randomized clinical trial. JAMA Pediatrics, 167(9), 826–835. http://dx.doi.org/10.1001/ jamapediatrics.2013.200. Hockenberry, M. J., & Wilson, D. (2009). Wong's essentials of pediatric nursing (8th ed.). St. Louis: Mosby.
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