The fear and anxiety induced by the perception of pain during medical procedures, particularly among pediatric patients, are significant concerns. As defined by the International Association for the Study of Pain, pain is described as an unpleasant sensory and emotional experience linked to actual or potential tissue damage [1].  Procedures like immunization and venipuncture, known to cause pain, intensify needle-related fear in pediatric patients. Research indicates that pediatric patients undergoing dental procedures, involving a substantial portion of sensory nerves in the oral-facial region, experience heightened anxiety compared to other medical treatments [2].

In the realm of dental procedures, anxiety and fear among patients can be exacerbated if effective pain management methods are not employed, given the involvement of needles and instruments. Even when local anesthetics are used, the administration of injections contributes to heightened fear levels, especially in the pediatric population. Studies reveal that approximately 67% of children harbor a fear of needles, leading to adverse emotional and psychological impacts [3].

Recognizing the necessity for advancements in technology to mitigate pain perception, anxiety, and associated negative effects in pediatric patients undergoing procedures involving needles and sharp objects, various approaches have been explored. One such technology, Buzzy®, has been developed for pain management and proven effective in reducing anxiety linked to medical procedures requiring needle administration [4]. This device employs non-pharmacological methods such as cold and vibrations to elevate patients' pain thresholds and diminish pain sensitivity [5].

Despite the widespread application of Buzzy® in medical procedures, limited research has focused on its effectiveness in alleviating pain perception during dental procedures in pediatric patients. This review aims to present an assessment of the use of the Buzzy® device, a non-pharmacological approach, in managing anxiety associated with the delivery of local anesthetics during dental procedures.

Managing Anxiety and Pain Perception in Pediatric Patients: Techniques and Strategies

The highest levels of fear and anxiety related to injections are observed in children, and generally diminish as individual’s age. Research indicates that nearly 67% of children experience fear of needles [6].  Prolonged exposure to needle-induced pain can lead to the development of needle phobia, particularly among children aged 5 to 10 [7]. Such pediatric patients may develop negative needle-related experiences, deterring them from seeking medical services, including vaccinations and routine checkups, due to situational anxiety [8,9].

Unfortunately, this anxiety tends to become deeply ingrained, as studies show that the fear of needles starts to develop around the age of four and may persist for an additional five to six years. By age eleven, some pediatric patients begin to cope with the fear of injections independently, with fewer negative side effects [10].

The perception of pain and anxiety during medical procedures can have psychological, physiological, and emotional consequences on patients [11]. Assessing the pain levels experienced by pediatric patients poses challenges, as some children undergo dental procedures before they can effectively communicate through speech. Efforts have been made to employ better subjective pain assessment methods, such as the Visual Analog Scale (VAS), Face Legs Activity, Cry, Consolability Scale (FLACC), and Wong–Baker pain perception scale.

The Visual Analogue Scale [VAS] serves as a pain rating system, gauging the intensity or frequency of diverse symptoms, including a patient's perceived level of pain, on a scale ranging from none to severe [12] (Table 1). Widely employed in assessing pain perception among pediatric and special needs populations with communication challenges, the FLACC scale, which stands for Face, Legs, Activity, Cry, and Consolability, utilizes a scale from 0 to 2 for each of the five criteria (Table 2).  Here, 0 indicates no discomfort, while 2 signifies extreme discomfort [13]. The Wong-Baker FACES pain rating scale adopts a visual approach, depicting the patient's pain level through line art faces on a scale from 0 to 5 or 0 to 10, illustrating various degrees of pain [14] (Figure 1).

Table 1: Visual Analogue Scale (Reference #9).

Table 2: FLACC Pain Scale (Reference #9).

Figure 1: Wong Baker Faces Pain Rating Scale (Reference #15).

While these pain assessment methods are prevalent and beneficial, they have limitations. Self-report assessments may be unreliable due to a child's innate fear of medical procedures or previous traumatic experiences. Consequently, there has been a need to develop ways to alleviate the perception of pain and anxiety during medical procedures. In pediatric dental settings, both pharmacological approaches (general anesthesia and oral sedation) and non-pharmacological methods (tell-show-do, positive reinforcement, parental presence, voice control) are utilized for pain management. Distraction techniques, including vibrating the injection site while engaging with the patient or showing hidden patterns and pictures, are commonly employed [16]. Virtual reality, with headphones, 3D-enabled goggles, and sensory input devices, has also been introduced as a non-pharmacological method to enhance the multisensory experience and reduce pain perception and anxiety [17]. However, the effectiveness of these methods varies among patients.

In recent years, various techniques, and devices, such as Vapocoolant spray, have been introduced to ease the needle administration experience. However, studies indicate that the use of such devices may not significantly reduce anxiety and fear associated with needle administration, requiring additional preparation time and specialized training for medical staff [18]. Therefore, it is crucial for healthcare professionals to carefully select pain management methods tailored to a child's age, developmental stage, and specific medical procedure, considering the preferences and interests of the patient.

While many cases of needle phobia stem from genetic factors and negative experiences with vasovagal reflexes, some phobias arise solely from previous traumatic encounters with needle administration [19]. Despite extensive research on the fear of needles and its associated anxiety, recent studies suggest that this fear continues to escalate with each successive generation [20]. This trend has sparked increased interest in exploring and researching strategies to mitigate the emotional and physical side effects linked to needle-related fears [21].

Numerous studies emphasize the necessity of adopting both conventional pharmacological and non-pharmacological methods in pediatric dental settings. However, not all techniques are universally applicable, as some prove challenging to implement, costly, or time-consuming. Across the globe, researchers have conducted numerous studies with the aim of developing medical equipment and devices that can make injection procedures less painful and induce minimal anxiety in patients. Specifically, for pediatric dental patients, the selection of non-pharmacological methods should consider the long-term effects of needle phobia-induced anxiety, striving for approaches that are easy to apply, age-appropriate, cost-effective, and engaging.

The Buzzy® Device, created by Dr. Amy Baxter, provides a practical solution for minimizing the perception of pain and anxiety associated with injections through conventional pain management methods. This bee-shaped device incorporates a battery-operated vibrating motor connected to removable ice wings, delivering a cold sensation [22]. Powered by AAA-size alkaline batteries, the device's 18g of ice wings can be stored in a freezer when not in use, secured to the bee's body with an elastic band. The ice wings maintain their frozen state for approximately 10 minutes at room temperature, enhancing the device's efficacy during painful medical procedures. Optimal results are achieved when the Buzzy® device is used with frozen wings. The procedure involves freezing the wings for about 1 minute before the medical operation and maintaining contact with the patient's skin throughout the procedure [23]. In the context of local anesthetic administration for dental procedures, the Buzzy device is positioned extra-orally (figure 3).

Figure 2: Buzzy® (Reference #22).

Figure 3: Buzzy® Placement for Maxillary and Mandibular Dental Anesthetic Injection (Reference #22).

The operation of the Buzzy® device aligns with the Gate Control Theory (GCT) proposed by Melzack and Wall in 1965 [24]. GCT posits that nonpainful stimuli, such as cold or vibration, can diminish the pain signal transmitted from the periphery to the brain by activating non-noxious fibers (A-beta) with larger diameters than pain-receptive fibers (A-delta and C-fibers), thereby intercepting the pain signal [2]. Consequently, medical procedures become less painful as inhibitory interneurons in the dorsal horn of the spinal cord are stimulated, reducing the pain information reaching the brain. Additionally, to further decrease sensitivity to pain, vibration is applied to the injection site and underlying bone to stimulate subcutaneous tissue, Meissner's corpuscles, and Pacinian corpuscles [2]. Furthermore, the reduction in pain perception achieved by Buzzy® is enhanced by the application of cold. Studies by Ballard et al. indicate that applying cold for an average of 40 seconds stimulates C fibers to relay noxious thermal information and slows the transmission of pain to the brain [3,25].

Research on the Efficacy of Buzzy In Medical and Emergency Settings

Canbulat et al. explored the effectiveness of external cold and vibration stimulation induced by the Buzzy® device on perception of pain and anxiety levels experienced in pediatric patients during peripheral intravenous cannulation during a randomized controlled trial. Wong Baker, Faces Scale and the Visual Analog Scale self-reports of the children were utilized to assess the patient’s anxiety during procedures. Results of the study showed significantly lower anxiety level in the experimental group with Buzzy® than the control group during the peripheral IV cannulation. Canbulat concluded that the Buzzy® is a useful device to aid in peripheral intravenous cannulation in pediatric patients [26].

 Lescop et al conducted a randomized trial investigating the efficacy of Buzzy® device versus a lidocaine patch for procedures requiring needles. Data revealed that Buzzy® failed to show an equivalent level of efficiency as the lidocaine patch in reducing perception of pain and anxiety among pediatric patients receiving needle injections based on the Faces Pain Scale [27]. However, it is worthy to note that Buzzy® is designed to combine cooling effect and vibration at the injection site. But based on the authors of this study, 40% of subjects in the Buzzy® group requested that the cold wings of the Buzzy® to be removed as the cold sensation was discomforting to them. Contrary to this shortcoming, the application of the Buzzy® required less preparation time; Lidocaine patch was placed on the injection site one hour prior to the anesthetic injection while the Buzzy® device was placed on the injection site for 30 seconds before the injection. Considering the limitations of the study, authors have concluded that Buzzy® could be an effective tool in reducing the patient’s needle related anxiety but no superior to the lidocaine patch. This result was consistent with similar studies by Bourdier et al [28] and Potts et al [29].

Bergomi et al, performed a randomized control trial study to evaluate the effectiveness of Buzzy® device versus animated cartoons in association with anxiety relief during needle administration among one hundred and fifty pediatric patients between the ages of five and 12 years old. Wong-Baker Faces Pain rating scale was used to measure the anxiety and perception of pain associated with needle injection. Data of the study revealed that patient’s perception of pain was less in groups where non-pharmacological interventions were rendered compared to the group with no intervention. Data presented a higher success rate in the Buzzy® group compared to the cartoon group. However, a considerable efficacy was observed in the Buzzy® and cartoon group combined based on the nurse’s perception of child’s pain [30].

Erdogan et al, performed a clinical trial to investigate the effect of distraction cards, virtual reality and Buzzy® on venipuncture pain and anxiety in pediatric subjects using descriptive characteristics form, and the Visual Analog Scale (VAS), Wong-Baker FACES, and Children's Fear Scale (CFS). Results showed that Buzzy® is a more effective pain alleviation technique than virtual reality and distraction techniques [16].

Support has been rammed up for more medical providers to use the device, since it is simple to operate, low-cost, noninvasive, and a reusable technology that promises to overcome the perception of pain and anxiety associated with needle related procedures [31]. The Buzzy® device’s ability to be used up to 100 times makes the pain management method cost-effective. Besides, the device can be effective in any settings with so little preparation time. All these benefits, promote Buzzy® as an effective non-pharmacological intervention in many medical procedures.

Effectiveness of Buzzy® in Pediatric Dentistry

Alanazi et al. conducted a randomized study to assess the effectiveness of Buzzy® in pediatric patients undergoing maxillary infiltration injections, comparing it to a conventional approach defined as no intervention. The observer dentist utilized the Wong-Baker pain scale and the Face, Extremities, Arms, Crying, and Comfort (FLACC) scale to document patients' perceptions of pain and anxiety. The study revealed significantly lower Wong–Baker and FLACC scores in the Buzzy® group compared to the conventional group. The authors concluded that the simultaneous application of vibration and cold could be beneficial in reducing anxiety and pain perception in pediatric patients. Despite the positive outcomes observed in the Buzzy® group, the authors discussed limitations associated with such devices and studies. They argued that selecting subjects for this study presented a challenge, as including very cooperative (Frankl ++) or very uncooperative (Frankl--) patients could potentially skew the results. Therefore, the authors cautioned that the findings of this study should not be generalized to all pediatric patients [32].

Subramaniam et al. conducted a randomized trial examining the efficacy of Buzzy® in pediatric patients undergoing mandibular block injection and maxillary infiltration [2]. Participants were randomly assigned to either the Buzzy® group or the control group with no intervention. Pain perception was evaluated using the SEM (sounds, eyes, motor) scale. In the intervention group, Buzzy® was positioned extraorally over the ramus of the mandible, and for the maxillary infiltration technique, Buzzy® was applied against the zygomatic arch of the maxilla.

Continuing from the previous information about Subramaniam et al.'s study on Buzzy® in pediatric patients undergoing mandibular block injection and maxillary infiltration, the results of the study indicated a significantly higher SEM score in the control group compared to the Buzzy® group. Despite acknowledging the subjective nature of pain perception studies, the authors believed their study was designed and presented with a high level of evidence. Their rationale stemmed from the use of SEM scales instead of conventional measures like the Visual Analog Scale (VAS) or Wong–Baker pain perception scale. The SEM scale recorded various indicators, including patient and child sounds, ocular and body-hand status observed by the dentist. The authors contended that this comprehensive observation of bodily language would help mask confounding factors linked to the innate fear often seen in pediatric patients undergoing needle-related procedures.

AlHareky et al. conducted a randomized trial to delve further into Buzzy®'s effectiveness against conventional methods, involving the application of topical anesthesia (20% benzocaine gel) for 15 seconds before injection [9]. To ensure a trial with a higher level of evidence, common pain perception scales were applied. The Face version of the VAS served as a subjective measure, and parents evaluated and recorded the patient's pain tolerance. Additionally, the SEM scale and FLACC scales were utilized to assess the child's perception of pain as observed by the dentist. The trial results revealed a statistically significant reduction in perception of pain and anxiety in the Buzzy® groups based on data collected using the VAS and FLACC scales. However, the SEM scale failed to show a significant difference between the intervention and control groups. The authors concluded that the combination of external cold compresses and vibration employed by Buzzy® could be a useful device for reducing pain and anxiety in pediatric patients undergoing needle injections.

AlHareky et al. found Buzzy® to be a practical solution for managing the perception of pain and anxiety among patients. However, they highlighted that using the device requires motivation and education on the patient's behalf [9].  Young patients should be allowed to interact with and learn about the device to desensitize them to its effects. The authors argued that if applied efficiently, Buzzy® can be an effective device in reducing anxiety among children undergoing medical procedures requiring needle administration.

Moreover, the device's distraction feature, attributed to its colorful design, easily catches the eye and diverts children's attention from the injection site, lowering their perception of pain, fear, and anxiety [20].  The design's simplicity helps eliminate innate fears associated with medical equipment. Children playing with the device in a healthcare setting contributes to reducing anxiety [33].  The device's ability to grab children's attention and distract them from the noise of other dental equipment in a dental office is considered beneficial [34].  However, despite being promoted as a fast-acting, user-friendly device, pediatric patients need time to become familiar with the device using proper desensitization techniques before anesthetic administration. Therefore, the time required should be taken into consideration when managing and scheduling treatment.

Exploring the Effectiveness of the Buzzy® Device in Pediatric Patients: A Call for Further Research

Recently published literature has highlighted Buzzy® as an effective tool for alleviating pain and anxiety associated with needle-related procedures. However, this reported success relies solely on observer reports via pain perception assessment tools, introducing a potential risk of experimental biases, particularly in pediatric populations. Notably, all the studies discussed in this review were designed as randomized trials, but none were blinded due to the inherent challenges in blindly assigning subjects to control and intervention groups.

To address potential biases, introducing biological elements such as pulse oximeters and blood pressure readings could mitigate risks. Despite reported success in the pediatric population, there has been limited research on Buzzy® in the dental community. This raises questions about the suitability of Buzzy®'s structural design for delivering vibration and a cooling effect to the injection site in dental procedures.

Following the manufacturer's instructions, Buzzy® should be placed near the injection site, making it nearly impossible for dental anesthetic injections often delivered intra-orally. Future studies should explore the limitations of an extraoral vibration device in reducing pain and anxiety associated with dental anesthetic injections compared to an intraoral vibration device.

Beyond vibration and cooling effects, Buzzy® is promoted as a colorful and engaging device designed to capture the patient’s attention and distract children during local anesthetic administration. This prompts questions about whether the engaging element of Buzzy® is limited to a specific age group in the pediatric population. Most published studies on Buzzy® in dental offices have focused on localized buccal infiltration, with only a small group of subjects receiving a mandibular block and none receiving palatal injections. Evaluating the efficacy of Buzzy® and its impact on needle-associated anxiety and fear in more invasive and painful injection techniques would be intriguing.

Furthermore, exploring whether the device maintains the same success rate in distracting patients during follow-up appointments is an interesting avenue for investigation. Limited published studies suggest that Buzzy® is helpful in reducing anxiety among patients undergoing invasive medical procedures, indicating a potential increase in adoption in medical and dental offices. Therefore, further evaluation of the efficacy of Buzzy® in reducing the perception of pain and anxiety in pediatric patients undergoing dental procedures is warranted.

The perception of pain before and during medical procedures, particularly among infants and children, contributes to heightened fear and anxiety. Negative experiences with needles can dissuade individuals from seeking medical attention and hinder the receipt of quality treatment due to trauma associated with painful procedures. Therefore, there is a compelling need to invest in research and development to create technologies that mitigate the perception of pain, fostering greater comfort and motivation for patients to seek and adhere to medical treatments. In the realm of dental care, the use of needles in the highly sensitive oral region is particularly distressing for pediatric patients, leading to significant emotional and psychological experiences. The Buzzy® device was specifically designed as a practical and cost-effective solution to alleviate fear and anxiety during needle injection procedures in this demographic. Employing non-pharmacological pain alleviation strategies, such as applying cold and vibrations at the injection site, recent studies indicate the effectiveness of the Buzzy® device in reducing the perception of pain and anxiety, thereby enhancing patient satisfaction levels. However, existing research on this device in dental offices primarily focuses on procedures involving local anesthetic delivered intraorally. Moreover, the available data from these studies relies either on self-reports from pediatric patients or observations made by dental providers, highlighting the limited quality of evidence. Recognizing these limitations, there is a clear imperative for future research tailored to a specific age group, aiming to comprehensively assess the efficacy of Buzzy® in diminishing the perception of pain and anxiety among pediatric patients undergoing dental procedures with intraoral injections.

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