Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535984
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
The Effect of White Noise and Swaddling on Pain Heart Rate and Oxygen Saturation in Term İnfants Undergoing Eye Examinations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of White Noise and Swaddling on Pain Heart Rate and Oxygen Saturation in Term İnfants Undergoing Eye Examinations A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 n30 the swaddling group n30 and the white noise swaddling group n30 along with a control group n30 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 collectionThere was no statistically significant difference in pain scores heart rates or oxygen saturation SpO2 between the intervention and control groups p005 In all groups pain scores and heart rates were higher and SpO2 values were lower after the ophthalmologic examination than before the examination p0001Swaddling 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
Detailed Description:
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 20000-40000 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 10000-20000 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 babys 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
H02 Swaddling infants during eye examinations does not affect pain scores heart rate or oxygen saturation
H03 Swaddling combined with listening to white noise during eye examinations does not affect pain scores heart rate or oxygen saturation
Methods This study was a prospective randomized controlled experimental study The study was conducted in the neonatal eye outpatient clinic of a maternity hospitalIn this hospital healthy infants who do not require intensive care after birth are given screening eye examinations once between the 30th and 36th days after birth Approximately 400 infants who do not need intensive care are admitted to the neonatal eye outpatient clinic each month Participants were divided into four groups three intervention groups and one control group Infants were assigned to these groups using simple random sampling to ensure homogeneity and prevent selection bias The sample size was calculated using the G-Power 3010 program With a confidence interval CI of 95 α 005 effect size 0159 and power 1 - β 080 a total sample size of 108 was calculated for the four groups with at least 27 infants in each group The study included 120 infants divided into the swaddling group n30 white noise group n30 white noise swaddling group n30 and control group n30 Figure 1 The sample included infants with a gestational age of 37 67 weeks birth weight 2000 g a 5th minute Apgar score 7 aged 30-36 days postpartum and undergoing their first eye examination The exclusion criteria included a history of hospitalization in the neonatal intensive care unit postnatal resuscitation presence or suspicion of a congenital andor genetic disease hearing problems surgical operation for any reason or systemic analgesic administration within the last six hours No infants dropped out of the study during the study periodInterventions Infants who were swaddled during the eye examination constituted the swaddling group Intervention Group-1 Infants who listened to white noise constituted the white noise group Intervention Group-2 Infants who were both swaddled and listened to white noise during the eye examination constituted the White Noise Swaddling group Intervention Group-3 The control group received routine care and follow-up The outpatient clinic nurse third researcher numbered the babies according to their order of admission and assigned them to groups by simple randomization All infants were examined by the same ophthalmologist fourth investigator Another outpatient nurse who was not part of the research team measured the infants pain scores heart rate and oxygen saturation at three different times before the examination T1 30 seconds after the ophthalmologist started the first eye examination T2 and immediately after the examination of the second eye was finished T3
Eye Examination Preparation All infants included in the study intervention groups 1 2 and 3 as well as the control group underwent routine procedures performed in the eye outpatient clinic before the examination During this stage pupil dilation was initiated in the waiting room According to the hospitals standard procedure the pupil dilation process involved instilling phenylephrine and tropicamide eye drops twice at five-minute intervals Liu et al 2017 Approximately 45 minutes later once the pupils were dilated each infant was taken to the preparation room One drop of proparacaine was instilled into both eyes of the infants before the examination Proparacaine-containing drops are used to provide topical anesthesia for rapid and short-term diagnostic or surgical procedures Bashinsky 2017 The third researcher then took the infants into the examination room and placed them on the examination table A pulse oximetry probe was attached to the left foot of all infants
Eye Examination Procedure
The third investigator placed the infant in a supine position and fixed the infants head in a midline slightly extended position The eye examination was performed by an ophthalmologist the fourth researcher Each eye examination took approximately one to one and a half minutes The groups were as follows
Swaddling group n30 The third researcher swaddled each infant with its thin blanket The swaddling involved bringing the infants left hand close to the left buttock and wrapping it with the upper right end of the blanket Similarly she wrapped the babys right hand with the upper left end of the blanket by bringing it closer to the right hip She wrapped the babys legs with the lower part of the blanket ensuring that the babys head could move freely
White Noise Group n30 The third researcher turned on white noise rain sound link httpswwwyoutubecomwatchvrZeM-HZeneo before the start of the eye examination and played it to the infants until the end of the examination
White Noise Swaddling Group n30 The third researcher swaddled the infants in this group as described in the swaddling group and turned on the white noise rain sound link httpswwwyoutubecomwatchvrZeM-HZeneo before the examination started and played it to the infants until the examination was over
Control Group n30 Babies in this group received care in accordance with the hospital routine In the hospital routine babies are examined with the clothes they are wearing during the examination and no non-pharmacologic method is applied during the procedure
All data collection was performed by a single outpatient nurse who was not part of the research team This nurse works in the neonatal eye outpatient clinic and has a neonatal intensive care nursing certificate
Data Collection Tools Infant Information and Monitoring Form The form was prepared by researchers Baş et al 2015 Francis 2016 Sun et al 2020 Turan et al 2021 and consisted of 11 questions The form included information about the infants demographic characteristics gestational age birth weight mode of delivery gender postnatal age diet Apgar score oxygen therapy and phototherapy Additionally T1 T2 and T3 pain scores heart rates and oxygen saturation levels were recorded
The Premature Infant Pain Profile PIPP The pain score of the infants was evaluated using the PIPP The Turkish validity and reliability of the scale developed by Stevens et al 2014 were performed by Taplak and Bayat 2019 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 Stevens et al 2014
Ethical Approval All procedures were conducted in compliance with the ethical standards of the Institutional and National Research Committee and within the guidelines of the Declaration of Helsinki Approval was obtained from the institution and the ethics committee date October 26 2020 number E2-22-2419 The parents of the babies were informed about the purpose method and other details of the study They signed a written consent form before the study commenced
Statistical Analysis Statistical analyses were performed using the SPSS version 27 IBM package program Descriptive statistics were used to interpret the findings Pearson-χ2 cross-tabulations were employed to examine the relationship between two qualitative variables For normally distributed data the ANOVA test F-table value was used to compare three or more independent groups and the Repeated Measures test F-table value was used to compare three or more dependent groups For non-normally distributed data the Kruskal-Wallis H test χ2-table value was used to compare three or more independent groups and the Friedman test χ2-table value was used to compare three or more dependent groups
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 babys 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
H02 Swaddling infants during eye examinations does not affect pain scores heart rate or oxygen saturation
H03 Swaddling combined with listening to white noise during eye examinations does not affect pain scores heart rate or oxygen saturation
Methods This study was a prospective randomized controlled experimental study The study was conducted in the neonatal eye outpatient clinic of a maternity hospitalIn this hospital healthy infants who do not require intensive care after birth are given screening eye examinations once between the 30th and 36th days after birth Approximately 400 infants who do not need intensive care are admitted to the neonatal eye outpatient clinic each month Participants were divided into four groups three intervention groups and one control group Infants were assigned to these groups using simple random sampling to ensure homogeneity and prevent selection bias The sample size was calculated using the G-Power 3010 program With a confidence interval CI of 95 α 005 effect size 0159 and power 1 - β 080 a total sample size of 108 was calculated for the four groups with at least 27 infants in each group The study included 120 infants divided into the swaddling group n30 white noise group n30 white noise swaddling group n30 and control group n30 Figure 1 The sample included infants with a gestational age of 37 67 weeks birth weight 2000 g a 5th minute Apgar score 7 aged 30-36 days postpartum and undergoing their first eye examination The exclusion criteria included a history of hospitalization in the neonatal intensive care unit postnatal resuscitation presence or suspicion of a congenital andor genetic disease hearing problems surgical operation for any reason or systemic analgesic administration within the last six hours No infants dropped out of the study during the study periodInterventions Infants who were swaddled during the eye examination constituted the swaddling group Intervention Group-1 Infants who listened to white noise constituted the white noise group Intervention Group-2 Infants who were both swaddled and listened to white noise during the eye examination constituted the White Noise Swaddling group Intervention Group-3 The control group received routine care and follow-up The outpatient clinic nurse third researcher numbered the babies according to their order of admission and assigned them to groups by simple randomization All infants were examined by the same ophthalmologist fourth investigator Another outpatient nurse who was not part of the research team measured the infants pain scores heart rate and oxygen saturation at three different times before the examination T1 30 seconds after the ophthalmologist started the first eye examination T2 and immediately after the examination of the second eye was finished T3
Eye Examination Preparation All infants included in the study intervention groups 1 2 and 3 as well as the control group underwent routine procedures performed in the eye outpatient clinic before the examination During this stage pupil dilation was initiated in the waiting room According to the hospitals standard procedure the pupil dilation process involved instilling phenylephrine and tropicamide eye drops twice at five-minute intervals Liu et al 2017 Approximately 45 minutes later once the pupils were dilated each infant was taken to the preparation room One drop of proparacaine was instilled into both eyes of the infants before the examination Proparacaine-containing drops are used to provide topical anesthesia for rapid and short-term diagnostic or surgical procedures Bashinsky 2017 The third researcher then took the infants into the examination room and placed them on the examination table A pulse oximetry probe was attached to the left foot of all infants
Eye Examination Procedure
The third investigator placed the infant in a supine position and fixed the infants head in a midline slightly extended position The eye examination was performed by an ophthalmologist the fourth researcher Each eye examination took approximately one to one and a half minutes The groups were as follows
Swaddling group n30 The third researcher swaddled each infant with its thin blanket The swaddling involved bringing the infants left hand close to the left buttock and wrapping it with the upper right end of the blanket Similarly she wrapped the babys right hand with the upper left end of the blanket by bringing it closer to the right hip She wrapped the babys legs with the lower part of the blanket ensuring that the babys head could move freely
White Noise Group n30 The third researcher turned on white noise rain sound link httpswwwyoutubecomwatchvrZeM-HZeneo before the start of the eye examination and played it to the infants until the end of the examination
White Noise Swaddling Group n30 The third researcher swaddled the infants in this group as described in the swaddling group and turned on the white noise rain sound link httpswwwyoutubecomwatchvrZeM-HZeneo before the examination started and played it to the infants until the examination was over
Control Group n30 Babies in this group received care in accordance with the hospital routine In the hospital routine babies are examined with the clothes they are wearing during the examination and no non-pharmacologic method is applied during the procedure
All data collection was performed by a single outpatient nurse who was not part of the research team This nurse works in the neonatal eye outpatient clinic and has a neonatal intensive care nursing certificate
Data Collection Tools Infant Information and Monitoring Form The form was prepared by researchers Baş et al 2015 Francis 2016 Sun et al 2020 Turan et al 2021 and consisted of 11 questions The form included information about the infants demographic characteristics gestational age birth weight mode of delivery gender postnatal age diet Apgar score oxygen therapy and phototherapy Additionally T1 T2 and T3 pain scores heart rates and oxygen saturation levels were recorded
The Premature Infant Pain Profile PIPP The pain score of the infants was evaluated using the PIPP The Turkish validity and reliability of the scale developed by Stevens et al 2014 were performed by Taplak and Bayat 2019 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 Stevens et al 2014
Ethical Approval All procedures were conducted in compliance with the ethical standards of the Institutional and National Research Committee and within the guidelines of the Declaration of Helsinki Approval was obtained from the institution and the ethics committee date October 26 2020 number E2-22-2419 The parents of the babies were informed about the purpose method and other details of the study They signed a written consent form before the study commenced
Statistical Analysis Statistical analyses were performed using the SPSS version 27 IBM package program Descriptive statistics were used to interpret the findings Pearson-χ2 cross-tabulations were employed to examine the relationship between two qualitative variables For normally distributed data the ANOVA test F-table value was used to compare three or more independent groups and the Repeated Measures test F-table value was used to compare three or more dependent groups For non-normally distributed data the Kruskal-Wallis H test χ2-table value was used to compare three or more independent groups and the Friedman test χ2-table value was used to compare three or more dependent groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None