Effectiveness of Gentle Touch Technique on Pain Level and Respiratory Parameters During Painful Procedures in Preterm Infants
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Karbala University
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Pain level
概览
简要总结
Preterm infants in neonatal intensive care units frequently undergo painful procedures that may affect their physiological stability, including pain level and respiratory parameters. Non-pharmacological interventions such as gentle touch technique are considered safe and effective methods for reducing pain in premature infants.
This study aims to evaluate the effectiveness of gentle touch technique on pain level and respiratory parameters during painful procedures in preterm infants admitted to neonatal intensive care units in Karbala teaching hospitals. The study will compare infants receiving gentle touch intervention with those receiving routine care to determine its effect on reducing pain and improving respiratory stability.
详细描述
Painful procedures are common among preterm infants admitted to neonatal intensive care units. These procedures may lead to physiological instability and increased stress responses. Non-pharmacological methods such as gentle touch technique have been suggested as effective and safe interventions to reduce pain and improve physiological outcomes.
This experimental study will be conducted among preterm infants admitted to neonatal intensive care units in Karbala teaching hospitals. A sample of premature infants will be selected using convenience sampling. The infants will be randomly assigned to the intervention and control groups using a simple random sampling method (lottery method) to minimize selection bias. One group will receive the gentle touch technique during painful procedures while the other group will receive routine care.
Pain level will be assessed using an appropriate neonatal pain assessment tool, and respiratory parameters such as respiratory rate and oxygen saturation will be measured. The study aims to determine whether gentle touch technique can significantly reduce pain and stabilize respiratory parameters among premature infants during painful procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with a gestational age range from 28 to 36 weeks.
- •Preterm infants admitted to the neonatal units of the selected teaching hospitals.
- •Preterm infants who were clinically stable at the time of data collection.
- •Preterm infants undergoing routine painful procedures as part of standard neonatal care.
- •Preterm infants who did not receive analgesic or sedative medications prior to the procedure.
- •Preterm infants whose parents or legal guardians agreed to participate in the study and provided informed consent.
排除标准
- •Preterm infants with a gestational age of less than 28 weeks or more than 36 weeks.
- •Preterm infants with congenital anomalies or genetic disorders.
- •Preterm infants diagnosed with neurological impairment or central nervous system disorders.
- •Preterm infants who were clinically unstable or required intensive medical interventions at the time of data collection.
- •Preterm infants receiving analgesic or sedative medications prior to the painful procedures.
- •Preterm infants with severe respiratory distress or requiring mechanical ventilation.
- •Preterm infants who had undergone any painful procedure within 30 minutes prior to the study procedure.
研究组 & 干预措施
Gentle Touch Group
Participants in the Gentle Touch Group received the gentle touch technique during painful procedures. The researcher warmed her hands and gently placed one hand on the infant's head and the other hand on the abdomen while maintaining the infant in a supine position inside the incubator. The gentle touch technique was initiated before the painful procedure and continued during the procedure and for a short period after completion of the procedure. The total duration of the intervention ranged from 7 to 10 minutes. The intervention was performed by the researcher under the supervision of the neonatal intensive care unit nursing staff.
Participants in the Control Group received routine neonatal care during the painful procedures without the application of the gentle touch technique.
Pain levels were assessed using the Neonatal Infant Pain Scale (NIPS), and respiratory parameters including respiratory rate and oxygen saturation were measured before, during, and after the painful procedure
干预措施: Gentle Touch Technique (Other)
Control Group
Participants in the Control Group received routine neonatal care during painful procedures without applying the gentle touch technique.
结局指标
主要结局
Pain level
时间窗: Before the painful procedure, during the procedure, and immediately after the procedure
Pain level will be assessed in preterm infants during painful procedures using the Neonatal Infant Pain Scale (NIPS). The NIPS ranges from 0 to 7, where higher scores indicate greater pain intensity. The scale evaluates facial expression, crying, breathing pattern, arm and leg movements, and state of arousal to determine the level of pain.
Respiratory Rate
时间窗: Before the painful procedure, during the procedure, and immediately after the procedure.
Respiratory rate will be assessed in preterm infants during painful procedures by measuring the number of breaths per minute using standard neonatal monitoring devices available in the neonatal intensive care unit (NICU). The normal respiratory rate in preterm infants typically ranges from 40 to 60 breaths per minute. Changes in respiratory rate will be used as a physiological indicator of the infant's response to painful stimuli and to evaluate the potential calming effect of the gentle touch technique.
Oxygen Saturation (SpO2)
时间窗: Before the painful procedure, during the procedure, and immediately after the procedure.
Oxygen saturation (SpO₂) will be continuously monitored in preterm infants during painful procedures using pulse oximetry monitoring devices available in the neonatal intensive care unit (NICU). The normal oxygen saturation range for preterm infants typically ranges between 90% and 95%. Oxygen saturation levels will be used to assess physiological responses to pain and to evaluate the potential stabilizing effect of the gentle touch technique.
Skin Color
时间窗: Before the painful procedure, during the procedure, and immediately after the procedure.
Skin color changes will be observed in preterm infants during painful procedures as a clinical indicator of physiological responses to stress and pain. Normal skin color in preterm infants is typically pink, while abnormal findings may include pallor (paleness) or cyanosis (bluish discoloration), which may indicate physiological stress or instability. These observations will help evaluate the infant's response to painful stimuli and the potential soothing effect of the gentle touch technique.
次要结局
未报告次要终点
研究者
Ruqaya Mohammed Jasim
Master's graduate student
Ministry of Health, Iraq