The Effect of White Noise and Swaddling on Pain, Heart Rate, and Oxygen Saturation in Term İnfants Undergoing Eye Examinations: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- heart rate value
研究概览
简要总结
Eye examinations for vision screening in infants cause pain and stress. Aim: To evaluate the effect of white noise and swaddling on pain, heart rate, and oxygen saturation in term infants undergoing post-discharge eye examinations. This study was conducted with term infants born 30-36 days postpartum who visited the ophthalmologic outpatient clinic for eye screening. A total of 120 term infants were included in the sample, divided into three intervention groups: the white noise group (n=30), the swaddling group (n=30), and the white noise + swaddling group (n=30), along with a control group (n=30). Data were collected by the clinic nurse before the eye examination, 30 seconds into the examination, and at the end of the examination. The Premature Infant Pain Profile (PIPP) scale and pulse oximetry were used for data collection.There was no statistically significant difference in pain scores, heart rates, or oxygen saturation (SpO2) between the intervention and control groups (p>0.05). In all groups, pain scores and heart rates were higher, and SpO2 values were lower after the ophthalmologic examination than before the examination (p<0.001).Swaddling + white noise, white noise, and swaddling during the eye examination procedure did not affect reducing infants' pain or improving heart rate and oxygen saturation values.
详细描述
Early childhood is a critical period for identifying and treating eye diseases, as problems that develop during this time can lead to permanent vision loss. It is recommended that term infants be evaluated for congenital cataracts, congenital glaucoma, retinoblastoma, strabismus, amblyopia, and refractive errors. An estimated 20,000-40,000 babies are born with bilateral cataracts each year globally, leading to blindness in over 14 million children. Congenital glaucoma, a developmental disorder that can be unilateral or bilateral, often occurs at birth or within the first few months of life and can damage the optic nerve, leading to vision loss. The incidence of congenital glaucoma in developed countries is approximately 1 in 10,000-20,000 births. Infections such as rubella and cytomegalovirus (CMV) during pregnancy can also cause cataracts and glaucoma in infants. Detecting risk factors that could impede normal vision development through infant vision screening and providing early treatment helps prevent vision loss and blindness. In Turkey, the national vision screening program includes routine eye examinations and red reflex tests conducted by family physicians for infants aged 0-3 years. Additionally, term infants who do not require intensive care undergo detailed examinations for eye diseases like congenital cataracts and glaucoma at two reference hospitals designated by the Ministry of Health. These examinations use similar methods to those employed in retinopathy of prematurity (RP) screening.
Eye examinations for screening and early diagnosis can be painful and stressful for infants. Exposure to pain can lead to hypersensitivity to painful stimuli, a decreased pain threshold, and altered cortex development in the short term, as well as long-term behavioral problems and learning difficulties. Therefore, it is crucial to minimize pain and stress during these examinations. Systemic pharmacological analgesics used to reduce pain in infants can negatively impact their early brain development, nutrition, socialization, and memory in later years. Currently, non-pharmacologic methods to reduce pain in infants are gaining prominence. These methods are more cost-effective, easier to administer, and safer compared to pharmacologic approaches. They can also be used in combination with pharmacologic treatments. Various non-pharmacological methods frequently used for analgesia in newborns and infants include kangaroo care, swaddling, non-nutritive sucking, exposure to specific odors (such as from the mother, breast milk, or aromatic scents), sucrose, glucose, breast milk, music therapy, massage, white noise, and acupuncture. During eye examinations, blefastop is used to keep the baby's eyelids open, and a scleral depressor is employed to assess the bottom of the eye and move the eye sideways, causing discomfort. The white light source used by the ophthalmologist further unsettles the baby. Studies have explored different non-pharmacologic methods to reduce pain during eye examinations in premature infants, including touch, positioning, non-nutritive sucking, breast milk, glucose, sucrose, white noise, and music. However, these studies have yielded conflicting results, and the evidence remains insufficient. Upon reviewing the literature, no studies were encountered comparing the effects of non-pharmacologic methods on reducing pain during eye examinations in term infants. There is a need for further research to investigate the effectiveness of non-pharmacologic methods in alleviating pain during post-discharge eye examinations in term infants.
This study aimed to evaluate the effect of white noise and swaddling on interventional pain, heart rate, and oxygen saturation (SpO2) in term infants undergoing hospital eye examinations for post-discharge vision screening.
Hypotheses of the Study:
H01: Playing white noise to babies during eye examinations does not affect pain scores, heart rate, or oxygen saturation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In the data collection process, the person collecting data was not blinded.
入排标准
- 年龄范围
- 30 Days 至 36 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants with a gestational age of >37 6/7 weeks,
- •birth weight ≥2000 g,
- •5th minute Apgar score ≥7,
- •aged 30-36 days postpartum,
- •undergoing their first eye examination
排除标准
- •a history of hospitalization in the neonatal intensive care unit,
- •postnatal resuscitation,
- •presence or suspicion of a congenital and/or genetic disease,
- •hearing problems, surgical operation for any reason,
- •systemic analgesic administration within the last six hours.
结局指标
主要结局
heart rate value
时间窗: Eye examination beginning and end (approximately 1-1.5 minutes)
oxygen saturation value
时间窗: Eye examination beginning and end (approximately 1-1.5 minutes)
The Premature Infant Pain Profile total pain score
时间窗: Eye examination beginning and end (approximately 1-1.5 minutes)
The Premature Infant Pain Profile (PIPP); The scale assesses seven items: gestational age, behavioral status, highest heart rate, lowest oxygen saturation value, forehead wrinkling, squinting, and widening of the wings of the nose. Each item is scored from 0 to 3 (from good to bad), with higher scores indicating greater pain. The total PIPP score ranges from 0 to 21, where 0-6 points indicate mild pain, 7-12 points indicate moderate pain, and 13-21 points indicate severe pain
次要结局
未报告次要终点
研究者
Sultan GÜNER BAŞARA
Erbaa Faculty of Health Sciences, Department of Nursing
Tokat Gaziosmanpasa University
