The Effect of Using Multifunctional Baby Carrier on Physiological Parameters, Pain and Sleep Status in Babies With Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Newborn Pain, Agitation and Sedation Scale (N PASS Scale)
研究概览
简要总结
The study aims to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, crying, and sleep status in infants aged 0-3 months who have undergone congenital heart surgery. It is planned to be conducted in a randomized controlled crossover design. Following congenital heart surgery, the use of sedative interventions in the high-stress environment of the intensive care unit has a significant effect on preserving the energy reserves necessary for the infant's growth and development. Using a sensitive and soothing mobile crib to assist in the postoperative care of infants who have undergone congenital heart surgery is a potential opportunity for the infant, nurse, and parent. The combined application of swaddling, sound, and movement reduces the baby's fussiness and has a calming effect on their physiological activation.
Infants who underwent heart surgery between 0-3 months and were followed up in a multi-purpose baby carrier (swaddling, white noise, and rocking) compared to infants in the follow-up experimental group, compared to infants in the control group who were only swaddled;
Hypothesis 1: The heart rate is lower. Hypothesis 2: Blood pressure is lower. Hypothesis 3: Oxygen saturation levels are higher. Hypothesis 4: Sleep durations are longer. Hypothesis 5: Pain scores are lower.
详细描述
This thesis study was designed to investigate the effect of using a multifunctional baby carrier with rocking, safe swaddling, and white noise features on physiological parameters, pain, crying, and sleep status in infants aged 0-3 months who underwent congenital heart surgery.
The sample size for the study, which is a 2x2 crossover design, was calculated using power analysis a large effect size and 80% power, resulting in a sample size of 52. Infants will be assigned to groups using simple randomization.
The dependent variables of the study are the infant's heart rate, blood pressure, oxygen saturation, sleep status, pain scale score, and crying duration. The independent variables are: the baby's gender, the baby's age, the postoperative day, the time spent at home with the parent, swaddling, white noise, and rocking.
Research groups: 1. Swaddling group (control), 2. Swaddling combined with rocking and white noise feature in a multifunctional primary cradle group.
In the crossover design, two groups were defined: Group A and Group B, where interventions were applied in different orders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Babies born at 38 weeks or later
- •Babies aged 0 to 3 months after birth
- •No illness other than congenital heart disease
- •Who has undergone surgery for the first time due to congenital heart disease
- •Whose clinical condition is stable (PSOFA score below 8 points)
- •Infants with stable thermoregulation
排除标准
- •Babies born before 38 weeks of pregnancy
- •Babies older than 3 months
- •The presence of other chromosomal or neurological disorders and syndromes in the infant
- •Those who have undergone two or more surgeries due to congenital heart disease
- •pSOFA score above 8 points
研究组 & 干预措施
Group A
Group A (26 babies) :
- Monitoring in a multifunctional baby carrier for the first 3 hours (experiment)
- Monitoring in an open incubator for the next 3 hours (control)
干预措施: Multifunctional Baby Carrier (Other)
Group B
Group B (26 babies) :
- Monitoring in an open incubator for the next 3 hours (control)
- Monitoring in a multifunctional baby carrier for the first 3 hours (experiment)
干预措施: Multifunctional Baby Carrier (Other)
结局指标
主要结局
Newborn Pain, Agitation and Sedation Scale (N PASS Scale)
时间窗: 6 hours
Term and preterm newborns are used for the purpose of evaluating postoperative pain/agitation and sedation. The total pain score ranges from 0 to +11. A high score indicates significant pain.
Sleep-Wake Status Measurement Device (Actigraphy)
时间窗: 6 hours
It is used to monitor babies' sleep-wake cycles.
次要结局
- Pediatric Sequential Organ Failure Assessment Score (pSOFA)(6 hours)
- Pediatric Sequential Organ Failure Assessment Score (pSOFA)(6 hours)
研究者
Aynur Baykal
PHD STUDENT
Istanbul University - Cerrahpasa