摘要：Background: Immunization is a medical procedure many children frequently undergo. As it involves pain, it is important to develop effective pain relief methods that are applicable from infancy. Objective: To clarify the pain-relieving effect of music from speakers on preschoolers during immunization. Methods: A randomized controlled trial using sex-based stratified randomization was conducted at a Japanese pediatric clinic between October and December 2016, involving 48 preschoolers aged 5 - 6. Among these, 25 listened to music (“Twinkle Twinkle Little Star” played by a music box) from speakers before, during, and after influenza immunization (Music group), while the other 23 were not treated with musical intervention (Control group), with the following outcomes: primary: the Face Scale score; and secondary: the heart rate (HR) and oxygen saturation (SpO2) and salivary alpha amylase (sAA) levels. Results: The Face Scale score and HR of the Control group immediately after influenza immunization were significantly higher than their baseline values (P < 0.0001, P < 0.05). There were no significant differences between the Music and Control groups in the Face Scale score, HR, or SpO2 level immediately after influenza immunization or in the sAA level 10 minutes after it. Conclusion: Influenza immunization was painful for preschoolers. When based on the Face Scale score, HR, SpO2 and sAA levels as indices to measure immunization-related pain, music did not show pain-relieving effects.
