Effect of White Noise in Relieving Vaccination Pain in Premature Infants

Effect of White Noise in Relieving Vaccination Pain in Premature Infants

Original Article Effect of White Noise in Relieving Vaccination Pain in Premature Infants --- - From the *Department of Child Health Nursing, Facult...

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Original Article Effect of White Noise in Relieving Vaccination Pain in Premature Infants ---

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From the *Department of Child Health Nursing, Faculty of Health Science, Ataturk University, Erzurum, Turkey; †Department of Neonatology, Research and Practice Hospital, Ataturk University, Erzurum, Turkey. Address correspondence to Aynur Aytekin, RN, PhD, Department of Child Health Nursing, Faculty of Health Science, Ataturk University, 25240, Erzurum, Turkey. E-mail: [email protected] Received August 12, 2014; Revised August 2, 2016; Accepted August 22, 2016. 1524-9042/$36.00 Ó 2016 by the American Society for Pain Management Nursing http://dx.doi.org/10.1016/ j.pmn.2016.08.006

Sibel Kucukoglu, RN, PhD,* Aynur Aytekin, RN, PhD,* Ayda Celebioglu, RN, PhD,* Arzu Celebi, RN, MSc,* Ibrahim Caner, MD,† and Rukiye Maden, RN†

ABSTRACT:

The purpose of this study was to evaluate the effect of white noise as a distraction method in relieving procedural pain caused by vaccination for premature infants. This experimental study was performed at a neonatal intensive care unit (NICU) of a university hospital in Turkey between July and September 2013. The study population was composed of 75 premature infants (35 in the study group and 40 in the control group) who met the inclusion criteria. Premature infants in the study group were exposed to white noise using MP3 players placed at the head of the infants’ open crib for 1 minute before vaccination. The white noise continued until 1 minute after vaccination. Premature infants in the control group were not exposed to white noise. The Premature Infant Information Form, Intervention Follow-up Form, and Premature Infant Pain Profile (PIPP) were used to collect study data. Descriptive statistics, chi-square test, and independent sample ttests were used to evaluate the data. The pain level of the control group (PIPP ¼ 14.35 ± 2.59) was significantly higher than the pain level of the study group (PIPP ¼ 8.14 ± 3.14) (p < .05). The authors found that 67.6% of the infants in the study group had moderate pain during vaccination and only 2.9% had severe pain. Most of the infants in the control group (82.5%) had severe pain, whereas 17.5% had moderate pain (p < .05). White noise was found to be effective for this sample; however, there is a dire need for extensive research on white noise and its use with this vulnerable population. Ó 2016 by the American Society for Pain Management Nursing

INTRODUCTION Pain is a special sensation that has both psychological and sensory aspects (Ovalı, 2008). It has been determined in various studies that pain is felt beginning in intrauterine life, and that a fetus can respond to pain beginning at 20-24 weeks of pregnancy (Anand & Phill, 2001; Velde, Jani, Buck, & Deprest, 2006). It is known that the anatomical, neurophysiological, and hormonal development needed to feel pain is complete and that neurotransmitter functions are highly developed in fetuses by late pregnancy. It also is reported that premature infants remember Pain Management Nursing, Vol -, No - (--), 2016: pp 1-9

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recurrent painful stimuli that occur in the early period and that they show an excessive response to these stimuli at later times (Ok, 2012). Hormonal, metabolic, cardiorespiratory, and behavioral changes occur in response to pain. The most important problem encountered when assessing pain in premature infants is the lack of verbal expression of the pain response. In measuring pain in infants, one should especially pay careful attention to nonverbal signs (Johnston et al., 2003; Ommaty, 2009). The presence and degree of pain and the response to treatment are evaluated by interpreting certain changes. Premature infants have physiological responses such as increased heart rate, increased blood pressure, increased respiratory rate, decreased oxygen saturation, and paleness or redness in response to painful stimuli (Collins, 2003; Karaayvaz, 2009). Premature infants also show a behavioral response to pain in the form of body movements, facial movements, and crying (Choonara, 1998; Collins, 2003). Premature infants often spend the first few weeks of life in the neonatal intensive care unit, where they experience pain and stress because of countless different reasons, and where they are exposed to many invasive procedures. The painful procedures in this period negatively affect the behavior of premature infants, adaptation to the external world, development of the brain, growth, and family–baby interaction (American Academy of Pediatrics, 2006; Committee on Fetus and Newborn, Committee on Drugs, Section on Anesthesiology, Section on Surgery and Canadian Paediatric Society, Fetus and Newborn Committee, 2000; Gilad & Arnon, 2010; Johnston et al., 2003). The goal in pain management of premature infants is to prevent the pain felt by infants who have faced painful procedures since the first moments of life, and to help them cope with that pain. One of a nurse’s primary responsibilities is to identify and ease pain correctly, as well as to ensure pain relief with methods applied during routine invasive procedures (American Academy of Pediatrics, 2006; Tamez and Silva, 2013). In line with this goal, pain in the neonate can be managed with effective care given through pharmacological and nonpharmacological means specific to the individual, after thorough and correct assessment (American Academy of Pediatrics, 2006; Karaayvaz, 2009). A variety of senses, such as vision, hearing, touch, and taste, are used in nonpharmacological methods for diverting attention to reduce pain in premature infants (Cignacco et al, 2007). Music is a highly effective stimulus in neonatal pain relief. Audio stimulation effectively distracts a baby and provides pain control and a cognitive strategy to suppress the pain response (Aydın & Yıldız, 2012).

The sound referred to as white noise or white sound is a continuous, monotone sound in the form of resonance that suppresses disturbing sounds coming from the outside environment and that has a soothing quality (Balcı, 2006). Given these characteristics, white noise is similar to the sounds in the mother’s womb. It is known that while still in the womb, the infant is affected by the mother’s heartbeat, and being exposed to these familiar sounds and rhythms after birth has a soothing effect on the infant (Balcı, 2006; Ovalı, 2005; Standley, 2001). There is evidence in the literature confirming that intrauterine sounds have stress-reducing, anxiety-reducing, pain-reducing, and soothing effects on the fetus/infant and that its physiological state is positively affected by such sounds (Balcı, 2006; Karakoc¸ & T€ urker, 2014; Ovalı, 2005). In the study of Balcı (2006) (N ¼ 30), it was determined that white noise had a positive effect on nutrition and sleep, and duration of crying decreased among infants in the group exposed to white noise. In an experimental study (Karakoc¸ & T€ urker, 2014) about effect of white noise and holding on the pain sensation of newborns (N ¼ 120) whose blood was drawn from the heel, the babies were divided into three groups. In the group I, babies were only held. The babies in group II both were held and listened to white noise. The babies in group III were lying down and only listened to white noise. The results of the research showed that the shortest period of crying during the painful procedures was noted in the group III newborns, who had only listened to white noise. In the another study about the effect of white noise on sucking success in newborns, newborns in the experimental group (n ¼ 63) were made listen to white noise on the first breastfeeding after birth and one more time 24 hours later, and their sucking success was evaluated. The results of the study determined that white noise listening by newborns in the early postpartum period increased their sucking success compared with infants in the control group (n ¼ 64) (Akca & Aytekin, 2014). Based on this information, this study was carried out to investigate the effect of white noise in easing the pain caused by vaccinations in premature infants who receive treatment in the neonatal intensive care unit.

MATERIALS AND METHODS This experimental study was performed at the neonatal intensive care unit of a university hospital in Turkey between July and September 2013. For the study, the sample size was determined because of power analysis, which had 95% test power with a 0.8 degree of impact and 85% representation power for the study

White Noise for Vaccination Pain

FIGURE 1.

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population. The population of the study consisted of the premature infants who were brought to the NICU between July and September 2013. The sample group was composed of 98 premature infants. Infants who met the inclusion criteria and received permission to participate in the study from parents were divided into two groups: 37 infants in the study group and 41 infants in the control group. Inclusion criteria for this study included premature infants who were 28-32 weeks’ gestational age, had no congenital or neurological problems, had no need for mechanical ventilation, had not received any analgesics or sedatives, had a stable health condition, had a passing score on an infant hearing test at 1 month of postnatal age, weighed more than 1000 g, and had parental consent to participate in the study. Twenty infants were excluded in the sample group; 17 infants did not meet the inclusion criteria. After data

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Flow of study.

collection began, two infants in the experimental group and one infant in the control group were dropped from the sample because of the parents’ decision to withdraw from the study. Figure 1 shows the study flow diagram for the enrollment of preterm infants. The sample group for the study consisted of 75 infants who were selected from the study population using the random sampling method. Randomization was ensured by using the date of birth to assign infants to the study group (even calendar days) and control (odd calendar days) groups. Which group was assigned to even or odd days was decided by using the method of drawing lots. Data Collection Data were collected by the researchers via the Premature Infant Information Form, Intervention Follow-up Form, and Premature Infant Pain Profile (PIPP), and

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the materials included an MP3 music player, a decibel meter, and a white noise CD. The PIPP, an observation-based tool, was filled out by the researcher and the observer nurse. Before starting the study, the observer nurse was trained by the researcher concerning the use of PIPP. The researcher and the observer scored the PIPP form simultaneously and independently by evaluating each infant separately. Correlation between the independent observers was tested by the McNemar test, and no difference was found between the observers (p > .05). The various forms used in this study are discussed below: Premature Infant Information Form: This form was prepared by the researchers to collect data about infants. The form included information such as gestational age at birth, birth weight, sex, birth height, and birth head circumference. Intervention Follow-up Form: This form was prepared by the researchers to obtain the premature infants’ physiologic data (i.e., vital signs plus oxygen saturation), recorded before and after the vaccination. Vaccination was performed while all vital signs were stable at least half an hour after routine care (i.e., feeding, skin care, diaper change, etc.). Premature Infant Pain Profile (PIPP): This scale, which was created by Stevens et al. (1996), is a paindiagnostic scale developed for 28- to 36-week premature infants. On this scale, heart rate, oxygen saturation, brow bulge, eyes squeeze, and the nasolabial furrow are taken into consideration together with gestational age and behavioral state. Each parameter is scored with 0, 1, 2, or 3 points (Table 1). The validity and reliability of the scale was demonstrated by Akcan, Yi git & Atıcı

(2009). Infants’ pain is assessed through the total score on the PIPP, from 0 to 21. The level of pain is mild if the PIPP is 0-6 points, moderate if it is 7-12 points, and severe if it is 12-21 points (Akcan, Yigit, & Atıcı, 2009). The PIPP’s Cronbach alpha coefficient was found to be 0.75 by Akcan et al (2009). In this study, the Cronbach alpha coefficient was found to be 0.71. In this study, premature infants were exposed to the same white noise that was used in previous studies (Balcı, 2006; Karakoc¸ & T€ urker, 2014), from the album ‘‘Colic,’’ by Orhan Osman of the On Music Production Company. Osman arranged this album by taking as a model the album ‘‘The Happiest Baby’’ by Dr. Harvey Karp, which was composed only of intrauterine sounds with the aim of soothing babies. In contrast to that album, Osman also used frequencies apart from intrauterine sounds and added sounds such as white noise and intrauterine frequencies. White noise was played by a music player with a sound level indicator and a portable speaker. The white-noise level was set to 55 dB, based on studies conducted on music therapy methods in infants (American Academy of Pediatrics, 1997; Balcı, 2006; Committee to Establish Recommended Standards for Newborn ICU Design, 2007; Karakoc¸ & T€ urker, 2014; Ovalı, 2005;). Vaccinations were administered by the nurse to infants in an open crib. The portable speaker was placed about 10 cm away from the head at bedside. The speaker was cleaned according to the infection control guidelines before the procedure. Intervention According to clinic procedures, vaccination with the second dose of hepatitis B vaccine was performed at

TABLE 1. Premature Infant Pain Profile Indicators

0 Point

1 Point

2 Point 28-31 weeks and 6 days Active/sleep Closed eyes Facial movements 15-24 beats/min increase 5.0-7.4% decrease Moderate Moderate Moderate

Gestational age

$36 weeks

Behavioral state

Active/awake Opened eyes Facial movements 0-4 beats/min increase 0-2.4% decrease

32-35 weeks and 6 days Quiet/awake Opened eyes No facial movements 5-14 beats/min increase 2.5-4.9% decrease

None None None

Minimum Minimum Minimum

Heart rate (maximum) Oxygen saturation (minimum) Brow bulge Eyes squeezed Nasolabial furrow

3 Point <28 weeks Quiet/sleep Closed eyes No facial movements 25 beats/min or more increase 7.5% or more decrease Maximum Maximum Maximum

None is defined as 0 to 9% of the observation time; minimum, 10% to 39% of the time; moderate, 40% to 69% of the time; and maximum as 70% or more of the observation time. In this scale, scores vary from zero to 21 points. Scores equal to or less than 6 indicate absence of pain or minimal pain; scores greater than 12 indicate the presence of moderate to severe pain (Stevens et al., 1996).

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30 days postgestational age for premature infants who weighed more than 1000 g. Vaccination of all the infants was performed by the same clinical nurse to maintain consistency in the technique. The vaccination procedure was performed on the vastus lateralis muscle by intramuscular injection to the infant in the open crib. No pharmacological or nonpharmacological pain relief methods were administered before, during, or after vaccination. All of the premature infants were evaluated with the PIPP, and the Intervention Follow-up Form was filled out before vaccination. Parents were allowed to stay in the NICU during the procedure, but did not provide comfort until after the vaccinations and pain assessments were completed. Study Group (n ¼ 35). After disinfecting the MP3 player surface and placing it on a sterile sponge inside the open crib, white noise was played for 1 minute before the hepatitis B vaccination was performed, and continued until 1 minute after the vaccination of the premature infants in the study group. Vaccination was performed according to the routine clinical application. After completing the procedure, the researcher filled out the Intervention Follow-up Form. The researcher and the observer observed the procedure during the vaccination and evaluated the procedure independently at the same time with the PIPP after the vaccination. Control Group (n ¼ 40). Hepatitis B vaccination of infants in this group was performed according to routine clinical practice, without any intervention. After completing the procedure, the researcher filled out the Intervention Follow-up Form. The researcher and the observer observed the procedure during the vaccination and evaluated the procedure independently at the same time with the PIPP after the vaccination.

Analysis Statistical analyses were performed using the Statistical Package for the Social Sciences software program (SPSS Inc., Chicago, Illinois) for Windows (version 18.0). Descriptive statistics were expressed as percentage, mean, and standard deviation. The control and study groups were compared by chi-square test and independent t-test. Cronbach’s alpha coefficient calculation was used to test the internal consistency of PIPP. McNemar test was used to estimate the agreement between the two independent observers. Significance was assessed at the level of p < .05. Ethical Considerations Because infants are a vulnerable population and fully dependent on nurses to manage their procedural pain, it is an ethical obligation to provide effective pain management. The authors believed that white noise similar to womb sounds could help newborns struggling with painful procedures. Approval of the local ethics committee and official permission were obtained from the relevant authorities to conduct this study. The purpose of the study was explained to all of the parents of the premature infants included in the study. Additionally, written informed consent was obtained from the family of each preterm infant.

RESULTS The sex, gestational age at birth, birth weight, birth height, and birth head circumference of the premature infants included in the study and control groups were similar (p > .05) (Table 2). Before the procedure, there was no statistically significant difference between the groups in terms of mean peak heart rate, respiratory

TABLE 2. Comparison of the Control and Study Groups According to the Information Characteristics of Premature Infants Study Group (n ¼ 35)

Control Group (n ¼ 40)

Characteristics

Mean (SD)

Mean (SD)

Test

p

Sex, n (%) Female Male Gestational age at birth, weeks Birth weight, g Birth length, cm Birth head circumference, cm

18 (51.4) 17 (48.6) 31.77 (3.30) 1673.29 (321.16) 41.09 (6.07) 30.70 (4.57)

24 (60.0) 16 (40.0) 31.30 (2.50) 1530.62 (347.25) 40.39 (2.67) 30.43 (4.75)

c2 ¼ 0.557

.304

t ¼ 0.702 t ¼ 1.838 t ¼ 0.659 t ¼ 0.255

.485 .070 .512 .800

SD ¼ standard deviation.

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TABLE 3. Comparison of Study and Control Groups Regarding Physiological Parameters before and after the Procedure Study Group (n ¼ 35)

Control Group (n ¼ 40)

Mean (SD)

Mean (SD)

t

p

150.51 (19.09) 57.63 (8.53) 91.68 (3.63)

155.82 (19.10) 53.64 (9.64) 89.95 (6.94)

1.201 1.875 1.327

.233 .065 .189

154.37 (18.06) 50.15 (11.24) 94.10 (17.42)

166.25 (25.78) 61.17 (10.88) 91.94 (16.76)

2.280 4.298 0.688

.026 .000 .494

Physiological Parameters Before procedure Peak heart rate Respiratory rate Oxygen saturation After procedure Peak heart rate Respiratory rate Oxygen saturation SD ¼ standard deviation.

rate, or oxygen saturation (p > .05). Following the procedure, the mean peak heart rate was 154.37  18.06 beats/min in the study group and 166.25  25.78 beats/min in the control group, so the difference between the groups was statistically significant (p < .05). In addition, the mean respiratory rate was 50.15  11.24 respirations/min in the study group and 61.17  10.88 respirations/min in the control group after the vaccination procedure (p < .05) (Table 3). A comparison of the level of pain in the infants in the study group showed that 29.4% had a mild level of pain, 67.6% had moderate pain, and 2.9% had severe pain during the procedure. There was no mild pain observed in the infants in the control group, whereas 17.5% had moderate pain and 82.5% had severe pain. A statistically significant difference was found between the groups according to PIPP pain levels (p < .05)

TABLE 4. Comparison of Study and Control Groups Regarding PIPP Scores

Pain Level 0-6 points, mild level 7-12 points, moderate level 13-21 points, severe level

Study Group (n ¼ 35)

Control Group (n ¼ 40)

n (%)

n (%)

Test and p

10 (29.4)

0 (0)

c2 ¼ 48.483 p ¼ .000

23 (67.6)

7 (17.5)

1 (2.9)

33 (82.5)

PIPP ¼ Premature Infant Pain Profile.

(Table 4). Before the procedure, the mean PIPP scores for all of the premature infants were equal at 0.00  0.00. The mean PIPP scores of premature infants in the control group during the procedure (14.35  2.60) were significantly higher than for the infants in the study group (8.14  3.14) (p < .05) (Table 5).

DISCUSSION One of the primary responsibilities of nurses working in neonatal units is pain management in infants. A variety of nonpharmacological interventions have showed effectiveness in the prevention and relief of pain in infants undergoing painful procedures (American Academy of Pediatrics, 2006; Czarnecki et al., 2011; Tamez and Silva, 2013). Nonpharmacological methods often are used, including oral administration of sucrose, kangaroo care, and breastfeeding (Aguilar Cordero et al., 2015). Revealing the effectiveness of alternative treatment methods and equipping nurses with these methods are important in neonatal pain management (Akcan, Yigit, & Atıcı, 2009). These

TABLE 5. Comparison of Mean PIPP Scores of Study and Control Groups Study Group (n ¼ 35)

Control Group (n ¼ 40)

Scale

Mean (SD)

Mean (SD)

Test and p

PIPP

8.14 (3.14)

14.35 (2.60)

t ¼ 9.359 p ¼ .000

PIPP ¼ Premature Infant Pain Profile; SD ¼ standard deviation.

White Noise for Vaccination Pain

methods have approved efficacy and low risk for infants, as well as low costs (American Academy of Pediatrics, 2006). Various factors, such as gestational age, sex, delivery method, nutrition, and diet, are important in pain perception and pain response in infants (Merenstein & Gardner, 1998). In this study, the descriptive characteristics of infants in the control and study groups, such as gestational age at birth, sex, birth height, birth weight, and birth head circumference, suggest that the infants included in the study were similar in terms of factors affecting pain perception and level of response. Because the physiological symptoms caused by painful stimuli show the general stress status of the body, they should be treated as symptoms caused only by pain (Hummel & van Dijk, 2006; Karaayvaz, 2009; Merenstein & Gardner, 1998). Although necessary, frequent painful procedures during hospitalization of preterm infants such as injections, blood draws, and vaccinations (i.e., ‘‘pain-related stress’’) may contribute to altered programming of neuroendocrine systems such as the hypothalamicpituitary-adrenal axis and thus influence stress-related behaviors in preterm infants (Grunau, 2013, Zouikr et al., 2014). The most common physiological symptoms, including heart rate, blood pressure, respiratory pattern, and oxygen saturation, are used to assess pain caused by acute procedures, whereas hormonal and metabolic variables are used to assess pain-related stress (Karaayvaz, 2009). In this study, there were no differences between peak heart rates, respiration rates, and oxygen saturations of the premature infants before the procedure (p > .05); however, the peak heart rates and respiration rates were higher in the control group after the procedure (p < .05). In the experimental study conducted by Kawakami et al. (1996), 131 normal full-term newborn infants under stress were allowed to listen to their mothers’ heartbeats or white noise, and it was determined that the stress indications of the group that listened to white noise were significantly lower than those of the heartbeat group and the control group. In Lee’s (2010) experimental study (N ¼ 40), it was found that maternal heartbeats made the behavioral conditions of fetuses and newborns stable. Music-related experiences not only meet the emotional needs of the newborn but also make them feel safe, especially in stressful periods (Whipple, 2008). In the semiexperimental study of Akca & Aytekin (2014), about effect of white noise on sucking success of newborns (N ¼ 127), it was found that sucking success scores of infants in the experimental group (n ¼ 63) exposed to white noise were higher than control group (n ¼ 64)

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scores. An experimental study (Whipple, 2008) reported the physiological and behavioral effects of music-reinforced pacifiers for 60 preterm infants experiencing heelstick. Infants were randomly assigned to one of three treatment groups: pacifier-activated lullaby (PAL), pacifier-only, and no contact. Whipple determined that the behavioral state and stress levels of the PAL group were more stable than for the other groups. Studies have shown that music in the NICU increases oxygen saturation and decreases heart rate, blood pressure, stress behavior, and length of hospital stay (Ahmadshah et al, 2010; Gilad & Arnon, 2010; Neal, 2008). In this study, it was found that the control group had a higher average pain score than the study group exposed to white noise (p < .05). Karakoc¸ and Turker (2014) conducted an experimental study on the effect of white noise and pain perception in newborns (N ¼ 120). The results of that research showed that the lowest NIPS points were experienced in the following order: newborns exposed only to white noise (4.10  2.92), newborns held in their mothers’ laps and exposed to white noise (4.15  3.07), and infants only held in their mothers’ laps (4.60  3.04). Furthermore, it was found in an experimental study (Balcı, 2006) (N ¼ 30) that a white noise CD played for babies with colic affected them positively and relaxed them. Crying (p < .05), screaming (p < .01), and awakening (p < .01) periods after noise exposure decreased compared with before exposure to white noise in the study. In an experimental study conducted by Tramo et al. (2011) (N ¼ 13), a soothing music similar to white noise was played for premature infants during heel sticks and stress and pain levels of the infants were found to be lower than in the control group. Music is a highly effective stimulus in pain relief. Audio stimulation effectively distracts the patient and provides pain control and a cognitive strategy to suppress the pain response (Hartling, Shaik, & Tjosvold, 2009; Kisilevsky et al., 2004; Standley, 2001). The present study showed results similar to previous studies. Implications for Nursing Neonates who are experiencing prolonged or persistent pain may not exhibit the usual behavioral signs of pain seen in neonates who are experiencing acute pain. Instead, they may exhibit signs and symptoms of energy conservation (American Academy of Pediatrics, 2006). The nursing staff may be most familiar with the infant or young child’s procedural pain behavior and pain management is one of the independent roles of the nurse in painful procedures performed on infants. Therefore, the nurse evaluates

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infant pain, plans pharmacological and nonpharmacological pain management strategies with the healthcare team, administers this plan, and assesses these practices’ effectiveness. The results of the current study will contribute to the use of evidence-based and nonpharmacological methods of pain management for pediatric nurses. Additionally, pediatric nurses should never prefer to use only white noise for pain management; pharmacologic management is the gold standard. Limitations of Study This study included infants whose parents gave permission for their inclusion in the study. Because of the small sample size, the results are not generalizable. In

addition, the researcher and observer were not blinded to the study groups during data collection.

CONCLUSIONS According to these results, white noise was found to be an effective method of managing the pain caused by invasive procedures such as vaccination. Therefore, it is thought that white noise can be used especially in painful procedures during the neonatal period, in addition to pharmacological methods, because its application is simple, inexpensive, and noninvasive. In addition, it is recommended that further research be conducted regarding the use of white noise in other areas of premature infant care.

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White Noise for Vaccination Pain

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