The Effect of Su Jok Therapy on Pain During Heel LanceProcedure in Newborn
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Neonatal Pain/Agitation and Sedation Scale (N-PASS)
研究概览
简要总结
Objective: To determine the effect of Su Jok therapy on pain levels during the heel lance procedure in newborns. The study will be conducted as a randomized controlled experimental trial with a pretest-posttest control group design. The heel lance procedure will be video recorded, and pain assessment will be performed independently by an experienced neonatal intensive care nurse with 7 years of clinical expertise and a neonatologist, using validated pain assessment scales.
详细描述
This study aims to examine the effect of Su Jok therapy on pain experienced during the heel lance procedure in newborns. Reducing pain associated with heel lance, one of the most commonly performed invasive procedures in the neonatal period, is crucial for the health and comfort of infants. Su Jok therapy is a non-invasive and side-effect-free method applied by stimulating specific points on the hands and feet, and in this study, it is considered as an alternative approach for pain management during heel lance procedures.
The research will be conducted between July 1, 2025, and July 1, 2026, in Family Health Centers affiliated with the Rize Provincial Health Directorate. A total of 66 term newborns (≥37 gestational weeks), consisting of 33 infants in the intervention group and 33 infants in the control group, will be included. The study sample size was determined using G\*Power 3.1.9.7 software. Based on a two-group (experimental, control) and three-measurement (pretest, procedure test, posttest) design with Two-Way Mixed ANOVA analysis, an effect size of 0.20 (f = 0.20), an alpha of 0.05, and a power of 90% (1-β = 0.90) were used, resulting in a required sample of 28 per group. Considering potential data loss, the sample size was increased by 20% per group, leading to a final sample size of 33 per group, 66 in total.
**Inclusion criteria:**
- Term newborns (≥37 gestational weeks)
- Without neurological disorders
- Who have not undergone any painful procedure (e.g., injection, venipuncture) in the previous 24 hours
- For whom heel lance for routine screening tests is planned
- Whose parents provided written informed consent
- Who have not received analgesic or sedative medications
**Exclusion criteria:**
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Statistics expert, Participant
入排标准
- 年龄范围
- 1 Day 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term newborns (≥37 gestational weeks)
- •Without neurological disorders
- •Who have not undergone any painful procedure (e.g., injection, venipuncture) in the previous 24 hours
- •For whom heel lance for routine screening tests is planned
- •Whose parents provided written informed consent
- •Who have not received analgesic or sedative medications
排除标准
- •Clinically unstable infants before or during the procedure (e.g., respiratory distress, cardiac instability)
- •Infants whose position was changed, intervention was interrupted, or procedure repeated in a way that could affect pain perception
- •Parental withdrawal of consent during the procedure
- •Severe restlessness or sudden physiological changes preventing pain assessment
- •Infants for whom standardized data could not be collected due to protocol violations
结局指标
主要结局
Neonatal Pain/Agitation and Sedation Scale (N-PASS)
时间窗: 12 months
The Neonatal Pain/Agitation and Sedation Scale (N-PASS) was developed by Hummel et al. in 2003 for use in all neonates, both term and preterm. A further advantage of the N-PASS is that it can be used to assess both acute and chronic pain, as well as in infants receiving mechanical ventilator support. The scale was revised by Pat Hummel on October 2, 2009 (Hummel et al., 2008; Hummel et al., 2010). The Turkish adaptation of the scale was performed by Açıkgöz et al. in 2011, who reported Cronbach's Alpha internal consistency coefficients of 0.797 for the pre-procedure period and 0.917 for during and post-procedure. The scale consists of two distinct sections: one for assessing the level of sedation and another for the level of pain. The N-PASS comprises five sub-parameters. These are: crying and irritability, behavior/state, facial expression, extremities (arms/legs) and trunk tone, and vital signs. In pain assessment, each behavioral and physiological criterion
Neonatal Introductory Information Form
时间窗: 12 months
This form was developed by the researcher and includes introductory questions regarding the newborn. The Neonatal Introductory Information Form contains items such as Apgar score, sex, weight, length, head circumference, feeding type, and feeding route. In addition, it includes a section designed to record the newborn's heart rate, oxygen saturation, and crying duration before, during, and after the heel lance procedure.
次要结局
未报告次要终点
研究者
Ayse Aydin
Principal Investigator
Ataturk University