Effects of Yakson Method Applied by Mother and Swaddling on Pain and Physiological Parameters During Heel Stick in Newborn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Neonatal Infant Pain Scale (NIPS):
研究概览
简要总结
Type of Study: The study was planned to be conducted in a randomized controlled experimental design.
Place and Time of the Research: Institutional permission will be obtained from the Balcalı Training and Research Hospital in Adana for the collection of research data. Researchers commit to start data collection after obtaining institutional permission. The data collection process will take 1 year after obtaining the institutional permission.
48 newborns who are suited the inclusion criteria will be included in the study. Participants will be assigned to 3 groups according to randomization: Swaddling, Yakson Method, and Control.
详细描述
Total processing time and baby's crying time are calculated by watching video recordings. In order to find the total procedure time, starting from the puncture of the baby's heel, the time until the dry cotton is placed on the baby's heel after the blood collection process is completed is calculated. The heart rate and SpO2 are noted by the investigator during the heel lancing procedure. Pain assessment of infants is done by two independent neonatal nurses, apart from the researcher, by watching video recordings. The scores given by the two observers will be evaluated by making inter-observer harmony. Before the evaluation, the nurses will be trained about the scale and its evaluation.
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
- Single (Outcomes Assessor)
盲法说明
After the researh report is written, a third person will assign an intervention and control group to the letters.
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for Newborn:
- •Born at term (38-42 weeks)
- •Healthy newborn
- •Absence of congenital anomaly
- •No analgesic or sedative medication has been administered in the last 6 hours
- •Parent's consent for inclusion in the study in accordance with the consent form
- •Inclusion Criteria for Mother:
- •Mother's willingness to participate in the study
- •The mother can be mobilized and not have a physical disability (so that she can appyl Yakson therapy for her baby)
- •Being communicative
排除标准
- •Babies whose blood cannot be drawn on the first try
研究组 & 干预措施
Control Group
Parents are informed about the research and verbal consent is obtained.
- Written consent is obtained with an informed consent form.
- The Mother-Baby Information Form is filled.
- Babies are fed 1 hour before blood collection.
- Before starting the heel lancing, a pulse oximeter probe will be attached to the baby's left big toe.
- Blood is taken from the right heel of the foot.
- During the application, the baby is recorded with the camera.
- Evaluation results are recorded in the application observation form.
Yakson Method Group
- The mother is informed about the benefits of the Yakson method.
- Yakson method is taught practically to the mother. Education continues until the researcher is sure that the mother has done the method correctly. The mother starts the application 10 minutes before the heel lancing is done and continues for another 5 minutes after the heel lancing is done. During the application, the baby is recorded with the camera. Just before starting the Yakson method (initial assessment), at 10 minutes of the Yakson method (just before the heel lancing), during the heel lancing while the Yakson method is in progress, and 5 minutes after the procedure (just before the end of the tender touch), the newborn's pain and physiological parameters are evaluated. Evaluation results are recorded in the application observation form.
干预措施: Nonfarmacology method (Other)
Swaddling Group
- Parents are informed about the research and verbal consent is obtained.
- Written consent is obtained with an informed consent form.
- The Mother-Baby Information Form is filled.
- Babies are fed 1 hour before blood collection.
- And researher swaddling the baby
干预措施: Nonfarmacology method (Other)
结局指标
主要结局
Neonatal Infant Pain Scale (NIPS):
时间窗: 1 year
This scale was developed in 1993 by Lawrence et al. for premature and newborns. The scale measures the infant's response to pain behaviorally. The total score of the scale ranges from 0 to 7, and scores higher than 3 indicate the presence of pain.
次要结局
未报告次要终点
研究者
Aslihan Hacisalihoglu
Research Assistan
Istanbul University - Cerrahpasa