Pain, defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage [1], significantly affects the mental health of neonates, infants and children, causing fear, anxiety, depression, and behavioral and cognitive abnormalities [2]. Additionally, the unpleasant experience or emotional state of pain may trigger physiological responses, including changes in plasma cortisol levels, fluctuations in blood oxygen saturation, increased heart rate and respiratory rate [3]. Venous-related punctures, including venipuncture, intravenous placement and blood sampling, are common in pediatric care and are among the most painful and terrifying medical procedures for children [[4], [5], [6], [7]]. If not managed effectively, these procedures may have immediate and long-term consequences, including delayed visits and medical evasion [8,9]. Effective pain management is thus essential in pediatric healthcare.

In the management of procedural pain in pediatric populations, both pharmacological and non-pharmacological interventions are endorsed as efficacious strategies [10]. Among the pharmacological therapies, topical anesthetics play a vital role in reducing pain for children undergoing needle procedures [11]. Various topical anesthetics are currently available, each with its own formulation and administration technique. Conventional agents that are commonly employed as topical anesthetics include the eutectic mixture of lidocaine and prilocaine (EMLA), as well as various lidocaine or amethocaine-based formulations. EMLA, which contains 2.5 % lidocaine and 2.5 % prilocaine, is widely recognized for its efficacy in alleviating pain from venipuncture by impeding pain conduction in the dermal layers [12]. However, despite its topical nature, EMLA may lead to adverse effects such as skin allergies, local numbness and systemic symptoms, including methemoglobinemia, particularly in neonates due to their compromised skin barrier function and low metabolic capacity for prilocaine [13]. Furthermore, the administration of pharmacological pain relief for venipuncture procedures may necessitate additional resources to manage adverse reactions and may incur substantial procurement and long-term usage costs [[14], [15], [16]]. Moreover, there exists a temporal cost linked to the delayed onset of action of EMLA, requiring application 60 min prior to the procedure under an occlusive dressing, which may be inconvenient in urgent clinical scenarios [17]. Therefore, the Infusion Nurses Society (INS) guidelines recommend considering pharmacological interventions only when non-pharmacological therapies prove inadequate or when the complexity of the procedure warrants it [18]. Non-pharmacological therapies include relaxation, play, psychological suggestion, hypnosis, music and cognitive-behavioral therapy [4]. These non-pharmacological therapies aid in regulating physiological markers, such as heart rate, blood pressure and respiratory rate, and in managing or preventing complications that may arise during hospitalization, including pain, anxiety and sleep disorders [19]. Among these non-pharmacological modalities, music-based interventions provide an economical, safe, non-invasive and valuable adjunctive method in various clinical treatments to alleviate pain and distress [[20], [21], [22], [23], [24]]. Moreover, music therapy circumvents the costs associated with drug-related complications and entails minimal operational expenses [25]. It can directly alter ascending pain-conducting neural modulatory factors through a range of actions that extend from the peripheral dorsal root ganglia to the cerebral cortex [26].

Research on the effectiveness of music therapy in alleviating pain, anxiety and distress during venipuncture in children has produced different results. While some studies demonstrated its effectiveness [26], others observed no advantage over traditional distraction methods [27]. The variability in study quality often leads to conflicting conclusions, highlighting the need for a comprehensive and systematic review of the effectiveness of music therapy in managing pain, anxiety and fear in pediatric patients.

A meta-analysis conducted in 2014 substantiated the efficacy of distraction techniques in alleviating needle-related pain among children [28]. However, this study exhibited two notable restricted: its scope was limited to four studies exclusively examining music therapy, and its temporal proximity precluded the incorporation of recent advancements in this domain. Recently, Ting et al. [24] published a systematic review and meta-analysis, which found that music therapy had significant therapeutic effects on improving children's heart rate, respiratory rate and stress levels. Recent meta-analyses predominantly have concentrated on the effects of music therapy on heel prick procedures in children [29,30], while research on venipuncture remains scarce. Furthermore, following the most recent meta-analysis, numerous randomized controlled trials examining music-based interventions in pediatric patients have emerged in the literature, thereby necessitating an updated systematic review and meta-analytic synthesis.

This study aims to systematically synthesize and critically evaluate the existing evidence from randomized controlled trials (RCTs) regarding the effectiveness of music-based interventions in alleviating pain and mitigating psychological distress among pediatric patients. The findings are anticipated to provide scientific evidence supporting the integration of music-based interventions into routine pediatric venipuncture services, thereby advancing innovation in pediatric care and promoting the delivery of holistic, patient-centered care.