Effects of Mother-Sung Lullabies on Vaccination-Induced Infant Pain and Maternal Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- State Anxiety Inventory (SAI)
研究概览
简要总结
Childhood pain can cause long-term and psychologically harmful effects. Music can reduce pain and anxiety. This study aimed to investigate the effects of the mother-sung lullaby during vaccine administration on vaccine-induced pain in babies and anxiety in mothers.
详细描述
This study aimed to investigate the effects of the mother-sung lullaby during vaccine administration on vaccine-induced pain in babies and anxiety in mothers. Two family health centers in Turkey between March 4, 2020, and August 28, 2020. A total of 60 babies who received the Bacille Calmette-Guérin vaccine and their mothers.These babies were randomly assigned to one of two groups, including 30 babies in the lullaby group and 30 babies in the control group. Data on descriptive information for all babies and mothers were collected through face-to-face interviews with the mothers before vaccination. Heart rate, oxygen saturation, and crying duration were measured in all babies. Heart rate and oxygen saturation of the babies were recorded using a pulse oximeter during and after vaccine administration. The crying time, measured for up to 30 seconds after vaccination, was recorded as the total cry time (using video seconds). The pain score was evaluated by two observers using the Neonatal Infant Pain Scale, based on video recordings obtained during and after vaccine administration. In addition, mothers' anxiety scores were measured using the "State Anxiety Inventory," both before and after vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The video recordings were evaluated by two academicians in the field of child health and disease nursing, including a researcher and a research assistant with a doctorate in child health and disease nursing who were not blinded to the group assignment. For each assessment, the observers watched the videos of the babies and conducted NIPS assessments during and after the intervention. These observers were blinded to the other's observations and did not discuss the scores.
入排标准
- 年龄范围
- 2 Months 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational age of 37-42 weeks
- •postnatal age at full two month
- •receiving the Bacille Calmette-Guérin vaccine
- •birth weight of 2500 gr or higher
- •no congenital anomalies
- •stable general condition
- •not taking any pain medication before vaccination
- •mothers were required to be older than 18 years and agree to participate in the study
排除标准
- •taking analgesic medication within 4 hours before the procedure
- •parents not willing to participate in research.
研究组 & 干预措施
The Lullaby Group
In this group, their mothers sang a lullaby during the vaccination process. Each mother touched her baby's hands and body while singing a lullaby and hugged her baby after the procedure.
干预措施: The Lullaby Group (Behavioral)
Control Group
In this group, their mothers did not sing a lullaby during the vaccination process.
Mothers touched their infant's hands and body and talk to their infants during and after vaccination. Mothers hugged their infant after the procedure.
结局指标
主要结局
State Anxiety Inventory (SAI)
时间窗: 6 MONTHS
The SAI was used in this study, which can be used to determines how an individual feels at a certain time and under certain conditions. The SAI consists of 20 questions, with scores ranging from 20-80. A high score indicates high anxiety, whereas a low score indicates low anxiety. The State Anxiety Inventory was used to determine the anxiety levels of the mothers before and after the vaccine administration.
Neonatal Infant Pain Scale (NIPS)
时间窗: 6 MONTHS
Neonatal Infant Pain Scale (NIPS) was used for the pain assessment. The NIPS consists of 6 behavioral sections, including facial expression, crying, breathing pattern, arm and leg movements, and wakefulness. Although 2 point values (0-1 point) can be scored for behaviors other than crying, 3 point values (0-1-2 points) are scored for crying. The total score ranges from 0 to 7, with higher scores indicated increased pain intensity.
次要结局
- Oxygen Saturation(6 MONTHS)
- Heart Rate(6 MONTHS)
- Crying duration of babies(6 MONTHS)
研究者
Pınar BEKAR
Assistant Professor
Mehmet Akif Ersoy University